Perceptions of and decision making about clinical trials in adolescent and young adults with Cancer: a qualitative analysis

Perceptions of and decision making about clinical trials in adolescent and young adults with... Background: Adolescent and young adults (AYA) enrolment rates into cancer clinical trials (CCT) are the lowest of any age group globally. As AYA have distinct biological, psychosocial and relational needs, we aimed to explore any unique factors influencing their CCT decision-making process, including AYA-specific perceptions or attitudes towards CCT. Methods: Qualitative interpretive descriptive methodology was used to explore AYA perceptions and decision-making related to CCT. An analytic approach conducive to inductive imagining and exploratory questioning was used in order to generate insights and interpret data. Results: A total of 21 AYA were interviewed (median age: 31 (18–39)). Twelve (57%) participants had previously been approached to participate in CCT. Major themes influencing trial enrolment decisions were: 1) severity of illness/urgency for new treatment 2) side effect profile of investigational drug in the short and long term (e.g., impact on future quality of life) 3) who approached patient for trial participation (oncologist vs. other) 4) additional information found on-line about the trial and investigators, and 5) family, friends and peer group opinion regarding the CCT. Conclusions: Several psychosocial and relational factors were identified as influencing AYA CCT decisions, some of which are unique to this demographic. Specific strategies to address barriers to CCT and enable supportive decision-making include: 1) involving family in decision-making and 2) helping AYA appreciate short- and long-term implications of trial participation. Finally, exploring social networking and general education about CCT that AYA can independently access may increase participation. Keywords: Adolescent and young adult, Attitudes, Barriers, Cancer, Clinical trial, Beliefs, Psychosocial, Perception Background research [3, 4], predominantly related to investigating sys- Adolescents and young adults (AYA), aged 15 to 39 years, tem and regulatory barriers impacting access [5]. Examin- represent a unique subset of cancer patients. With over ation of perceptions and attitudes towards CCT, also 70,000 AYAs diagnosed with cancer in the United States known to impact trial participation, has been limited to annually, and 7600 diagnosed in Canada, this group repre- children/AYA in pediatric institutes [6–8], older adults [9, sents approximately 4–5% of the North American adult 10] and other marginalized populations [11], with few cancer population [1–3]. Lack of enrolment of AYA onto studies focusing specifically on AYA treated in adult can- cancer clinical trials (CCT) has been the focus of much cer centers. CCT enrolment decisions are influenced by a variety of factors including altruism, scientific benefit, recom- mendations from medical personnel [12–14] and belief * Correspondence: abha.gupta@sickkids.ca Abha A. Gupta and Jeremy Lewin contributed equally to this work. that CCT offers the best treatment [15]. Potential bar- Adolescent and Young Adult Program, Princess Margaret Cancer Centre, riers to CCT enrolment include lack of trial awareness Toronto, Canada [16], concern about side effects [10, 17], medical mis- Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada trust, including fear of being a guinea pig [11, 18], Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Bell et al. BMC Cancer (2018) 18:629 Page 2 of 8 protocol stringency [10], belief that risks outweigh bene- identified potential participants during their regular out- fits [14], concern regarding potential conflicts of interest patient clinics and made initial contact with them regarding [19] and lack of trial availability or opportunity to par- the study. Those patients who were interested in learning ticipate [16]. However, there is limited information about more were referred to two members of the study team (VF the role that personal, socio-demographic characteristics, (female, medical student); ST (female, nursing student)) with and other factors might play in the acceptability of CCT whom the patients did not have any previous clinical rela- for AYA [7, 8, 20–25]. AYA CCT enrolment decisions tionship. These study team members provided a thorough occur in the context of cognitive and emotional develop- background of the study and patients were given as much ment/growth, and self-identity maturation. As a result, it time as they needed to consider the study information and is likely that unique psychosocial and relational factors provide informed consent or refusal to study participation. place additional stress on and influence their CCT Prior to the interview, participants were asked to decision-making process [26]. Thus, this study aimed to complete a demographics form. Participants were given investigate AYA-specific perceptions or attitudes to- the option to conduct the interview at the current time, wards CCT in an adult comprehensive cancer centre or to schedule an interview time in the future. Patients and explore additional factors that may influence AYA who participated in an interview were given a $10 gift decision-making about CCT. card for their time. Methods Data collection Study design Semi-structured face-to-face interviews were conducted Qualitative interpretive descriptive methodology was with each participant in a private setting at the hospital. used [27]. This discovery-oriented approach allows for a All participants individually engaged in the interview but process whereby the researchers remain open to deriving out of respect for the preferences and desires of some insights from the data in order to inform understandings AYA participants, a family member or friend was that answer questions relevant to clinical practice [28]. allowed to be present during the interview to support To do so, in-depth exploration of participants’ experi- them. In these cases, the family member or friend ences is sought with the aim of identifying thematic pat- quietly observed the interview and only a few interjected terns and commonalities, while simultaneously occasionally to give additional information that the par- accounting for individual variation [27]. The overarching ticipant had missed about a certain event or in re-telling goal of interpretive description within this study was to a story. Most of the time the family member or friend identify clinically relevant insights to support AYA deci- was silent. sion making and enhance trial participation. The study An investigator-developed interview guide was created was conducted through the AYA Program at Princess to explore participants’ understanding of CCT, trial expe- Margaret Cancer Centre, Canada [29, 30]. Research eth- riences, factors that influence their decision-making about ics board approval was obtained prior to study com- trial enrolment, and AYA-specific perceptions or attitudes mencement (CAPCR 16-5376). Participants completed towards CCT (see online Additional file 1: Table S1). The written informed consent generally within 24 h of being guide was influenced by previous literature on the barriers approached and prior to any study procedures. They to CCT as experienced by other populations while allow- were reminded of their right to withdraw from study ing for open-ended responses. The research team participation at any time without affecting their care. reviewed the guide to ensure that questions were all-encompassing and contained the necessary probes to Sampling and recruitment help facilitate informative responses. Participants were Eligibility criteria for participants included: patients aged conveyed a working definition of CCTs as defined by the 15 to 39 years upon cancer diagnosis; currently receiving National Institute of Health [31]. Preliminary interviews cancer care (active or in surveillance); and ability to en- were conducted and analyzed to further refine the inter- gage in an interview. Those unable to speak English, or view guide in terms of applicability, ease of use, and effi- who had severe cognitive impairment that would limit ciency. Interviews were conducted with one of two their participation were excluded. Patients with investigators (VF and ST) under the guidance of a mem- leukemia, lymphoma, sarcoma, breast and testes cancer ber of the research team (JB), who has extensive experi- were purposefully recruited with diverse backgrounds ence and training in conducting qualitative interviews. with respect to age, clinical trial experience (accept, Interviews were digitally recorded and transcribed verba- decline, or neither) and treatment goals (metastatic or tim by the researchers (VF and ST). The duration of the disease free). interviews was variable (between 30 min to an hour and a The principal investigators (AG (female, oncologist); JL half). Transcripts were not returned to participants for (male, oncologist)) who were part of the circle of care comment. Bell et al. BMC Cancer (2018) 18:629 Page 3 of 8 Data analysis related to each theme were purposefully sought in order Qualitative data analysis exists on a spectrum of data to understand individual variation and to provide a more transformation from description to interpretation [32]. comprehensive perspective of the collective experience. Because our research aimed to inform clinical practice change, an analytic approach closer to description was Results used in order to generate insights and interpretation of Twenty-three AYA were approached to participate in the interview data related to the research objective [27]. the qualitative interviews between June and August, Two members of the research team (VF, ST) independ- 2016. Of the 23 AYA approached, 21 consented to par- ently reviewed three interview transcripts with the intent ticipate. Eight AYA participant interviews included their of developing “broad-based” codes (as opposed to family member or friend. Participant characteristics are line-by-line coding) ([27], p., 160). These codes were re- shown in Table 1. The median age of participants was 31 flective of those ideas, words or phrases identified as (18-39). Twelve (57%) participants had been approached relevant to the research aim. Broad-based or generic to participate in CCT of which 10 (48%) had enrolled. codes allowed the researchers to remain open to the ut- The majority of these participants (N = 9; 90%) had en- terances and meanings within the data so that they rolled at the time of recurrence or during treatment for might be further interrogated and allow for interpretive metastatic disease. thinking [27]. The researchers then met to compare and contrast codes with a third member of the research team Major themes (JB), and to establish inter-coder reliability. Consensus Major themes were categorized into positive, negative was reached between team members (VF, ST, JB) on the and neutral influences on CCT participation as guided creation of new codes or the collapsing of data into by the research objective (Fig. 1). Positive influences en- existing codes, and the building of detailed descriptions abled CCT participation, negative influences detracted to form an initial coding framework. The initial coding from CCT participation, and neutral influences either framework was then applied independently by each re- had no effect on CCT participation or were described by searcher (VF, ST, and JB) to four more transcripts. The participants as supportive of their trial decision-making researchers (VF, ST, and JB) met again to discuss any process. The top five most frequent thematic influences discrepancies in codes and in applying the initial coding on AYA decision-making regarding CCT participation, framework. Based on this discussion, the initial coding as identified in ≥90% of participant interviews, were: se- framework was modified and distributed to the entire re- verity of illness/urgency of treatment, influence of side search team for review. After review and approval, the effects, recruitment method, additional information, and coding framework was applied by the researchers (VF, opinion of others (Table 2). ST) to the remaining transcripts. Codes were continually compared between and among transcripts as the re- Positive influences on CCT participation searchers asked questions of the data such as “how im- portant is this experience to AYA decision making?” and Severity of illness/urgency of treatment Severity of ill- “is this code qualitatively different than that code?” [28]. ness/urgency of treatment was discussed by a majority of Further, potential relationships between identified codes those interviewed, and was identified by participants as a were explored in order to inform a cohesive and positive influence on AYA’ willingness to participate in clinically-relevant account of influences on AYA CCT CCT. Most AYA stated they would enrol in a trial out of decision making [27]. desperation if they had not responded effectively to the The generation of major themes was guided by a for- standard treatment available and their disease was pro- mal code repetition analysis whereby one member of the gressing or in an advanced stage. As reported by one research team used standard word processing software participant, age 38 (disease free, never been offered a (Microsoft Word) to count the number of times each trial), “If I’ve been given a bad prognosis […] I would code was identified in the transcripts [33]. This exercise probably be willing to participate [in a clinical trial], be- served as a proxy for presumed importance of the ex- cause maybe this new drug might help me”. Similarly, a perience. Major themes were identified as those codes, 36 year-old participant (metastatic disease, currently en- ideas or experiences that had the most textual support rolled on a clinical trial) stated, “I don’t have another op- from multiple transcripts. To promote trustworthiness tion. Radiation is not an option, surgery is not an of the findings [34], major themes were reviewed by the option, so [a clinical trial] is what I’ve got”. Only one entire research team and compared and contrasted with participant said that they would have enough options previous literature on CCT participation in diverse pop- available so that CCT would not be worth their while. ulations as well as the clinical experience of the Another participant did not mention severity of illness/ clinician-investigators. In addition, alternate perspectives urgency as a concern. Bell et al. BMC Cancer (2018) 18:629 Page 4 of 8 Table 1 Participant Characteristics Total participants (n, %) 21 Age, Median (Range) 31 (18-39) Gender Male 10 (48) Female 11 (52) Cancer Diagnosis Testes 3 (14) Leukemia 3 (14) Lymphoma 6 (29) Breast 3 (14) Sarcoma 6 (29) Previous Trial Involvement Approached regarding CCT 12 (57) Phase I 2 (10) Phase I/II 3 (14) Phase II 3 (14) Phase III 4 (19) Not Approached regarding CCT 9 (43) Enrolled on CCT 10 (48) Enrolled at time of diagnosis 1 (5) Enrolled at time of recurrence or during 9 (43) treatment for metastatic disease. English as first language Yes 18 (86) No 3 (14) Student and employment status Currently Working 6 (29) Working prior to diagnosis 13 (62) Currently at School 3 (14) Completed university degree Yes 14 (67) No 7 (33) Children Yes 9 (43) No 12 (57) Mean no. of dependent children 1.3 Relationship Status Single 4 (19) In a Relationship 8 (38) Married 9 (43) Negative influences on CCT participation participant was concerned only if side effects had a high probability of occurrence. Other participants believed Trial side effects Influence of side effects was discussed that CCT offered the best chance of cure so they would in most of the interviews. This theme referred to consid- endure any side effects, or they downplayed the signifi- erations of how the experience of drug side effects cance of side effects, perceiving they would be easily would influence CCT participation. Participants per- treated while on trial. Approximately half of participants ceived the possibility of trial side effects in diverse ways. stated that long-term or severe side effects were quite It could either act as a deterrent towards enrolling, or it concerning and that they would need to thoroughly con- was described as having little to no effect on a patient’s sider their participation prior to enrolment. These par- decision to enrol. Over half of participants stated they ticipants stated the need to weigh the potential for side would consider side effects prior to enrolling in a clinical effects to impact their future quality of life (QOL) trial, while only a few participants said side effects were against the therapeutic gains from the trial. One 23 year-- not a major concern. Several participants stated they old participant (metastatic disease, currently enrolled on had no other treatment options available so they would a trial) mentioned that, “If [the side effects were] some- try any treatment regardless of side effects; one thing like numbness [..] I would still go through with Bell et al. BMC Cancer (2018) 18:629 Page 5 of 8 Fig. 1 A total of 35 themes were identified as influencing AYA patient decisions regarding enrollment in CCT. These themes were classified as either positive, negative or neutral influencers affecting AYA clinical trial enrollment [the clinical trial] because my options are getting smaller decision to enrol or not. This theme included partici- as more regimens are not working for me. But if it was pants’ preferred method of being approached about a something pretty serious I would explore my options be- trial (through email, in-person, or over the phone) along sides this”. When separated by stage of disease, five of with the timing of approach and from whom they would six patients without active disease shared concerns re- prefer to hear about a clinical trial for the first time (e.g. garding long-term side effects from CCT as opposed to from an oncologist, nurse or member of the research eight of 15 for those with metastatic disease. team). More than half of participants said they preferred their Neutral influences on CCT participation oncologist to initiate a trial conversation, while the remaining were ambivalent as long as they had the ne- Recruitment method Recruitment method was de- cessary information to answer any questions they might scribed in all of the interviews. This was a general theme have about the trial. There was no consensus regarding used to encompass descriptions of how trial personnel the preferred timing of being offered a trial or how re- had approached AYA patients about trial participation, cruitment should be initiated, although some partici- and reflections on how this might influence their pants thought they should only be approached about a Table 2 Five prevalent themes influencing AYA decision making were identified in ≥90% of participants Theme Theme Example Classification Positive Severity of illness/urgency (95%) “I brought up side effects a few times, but if there weren’t really any options or the current options weren’t working and my team was at a loss of what to do. I don’t see that I would have a choice.” Negative Concern about side effects (90%) “Yes, it would. Permanent side effects? No thanks. The side effects I’ve already been having with chemo are harsh enough... definitely side effects would be huge thing” Neutral Recruitment method (100%) “I was approached very nicely and academically and they gave me the right information. I was able to meet a lot of different professionals working on the trial and felt confident because I got a lot of different perspectives by different teams.” Additional information (95%) “I like that I was able to talk about it with my doctor… I know ultimately I make most of the decisions for myself but I hold him in very high regard.” Opinion of others (100%) “My friends and family are very informed and aware of what is going on with me. Always want to come to the hospital and they all do their own research…It’s great, I am very supported.” Bell et al. BMC Cancer (2018) 18:629 Page 6 of 8 trial if their standard treatment was not working. Add- understand the barriers to trial participation. In this itionally, participants believed an offer of trial participa- study of AYA at a large adult comprehensive cancer tion should not be extended to patients who had just centre, several overarching themes were identified re- been diagnosed, thinking these patients would be too garding psychosocial and relational factors influencing overwhelmed or not in a stable state of mind to receive AYA CCT decisions, some of which are unique to this further information about clinical trials. demographic. Many AYA were concerned about both short- and Additional information long-term side effects and outcomes of CCT on their fu- Seeking additional information was discussed in most of ture QOL. Of note, we did not specifically probe partici- the interviews. This theme related to the role additional pants as to whether the toxicity concerns were in information played in participants’ decisions about CCT addition to standard of care drugs (which are often the participation. Almost all participants reported conduct- comparator arm of many CCT) that often carry their ing online research for published studies or gathering own side effect profile. Although drug side effects are a more information about the protocol and study investi- factor in adult cancer patient trial decisions [10, 35], the gators. A few participants sought a second opinion from priority AYA place on longer-term implications appear an oncologist who was not their primary physician for to be unique to this cohort. Hope for longevity likely in- more information or to explore additional treatment op- fluences AYA’ concerns about the long-term impacts of tions. Two participants said they would try to contact an investigational agent on future QOL. Whereas older previous clinical trial participants to obtain their per- adults may perceive themselves as having lived a signifi- spectives and experiences in order to inform their deci- cant proportion of their lives, and focus on giving back sion making. to others through trial participation [12–24], our find- ings suggest AYA’ future-oriented considerations may be Opinions of others closely intertwined with stage of disease and consider- Opinions of others was described in all of the interviews. ations of what is best for one’s self in making a trial deci- This theme related to the ways in which the opinions of sion. This emergent finding may have important family members or friends influenced the clinical trial implications for how trials might generally be promoted decision. The majority of participants said that family or discussed with AYA. For example, public advertise- would be involved in the clinical trial decision-making ments emphasizing the benefit of helping others may process by helping them to make a decision, supporting not be as relevant for AYA [36]. their search for more information about the trial, or Another central theme we identified is method of re- helping them to stay informed about the clinical trial cruitment. Participants indicated they would not want to process throughout recruitment and study participation. be approached for a CCT if they had just been diagnosed Only one participant excluded family in the clinical trial or were otherwise overwhelmed with their treatment decision. This 28 year-old female explained that she course. Distress or uncertainty has been identified as a made the decision to enrol in a CCT immediately after detractor of decision-making ability in a wide range of the doctor offered the option due to its high success treatment contexts [37]. Previous literature has demon- rate. She stated that her only other treatment options strated that adolescents between the ages of 14-18 years would not offer a chance for a full recovery, so the CCT may have greater difficulty self-regulating their emotions was the best option. Two participants stated that family in response to a life-threatening illness [38], which may pressured them with regards to clinical trial participation make managing their distress in the context of trial as opposed to simply offering their opinion. A 21 year-- decision-making even more challenging. Our findings old patient (metastatic disease, had previous clinical trial suggest an important role for professionals to respond to experience) explained how her father hurried her deci- AYA psychological needs, and a CCT recruitment ap- sion and encouraged her to participate based on altruis- proach that encourages their capacities to make an in- tic reasons. “[From] my dad, I think it was a bit more of formed trial decision. For example, approaching AYA pressure to join the trial […]. If I were alone I would’ve about a study using simplified age-appropriate language, thought about it for a little bit longer, and maybe I acknowledging their emotions and offering further sup- wouldn’t have done it”. She stated her father “pushed” port/resources tailored to their situation, and addressing her into enrolling in a clinical trial, as it would be “great any practical barriers to CCT participation (e.g., child for research” and “improve the outcome for others.” care, transportation). In this study, AYA preferred their oncologist to introduce them to a trial rather than an in- Discussion dependent trial nurse. As such, educating oncologists in As AYA enrolment rates into CCT are the lowest of any adult cancer services of the unique needs of AYAs may age group globally, a major focus of recent research is to aid in recruitment onto CCT. Bell et al. BMC Cancer (2018) 18:629 Page 7 of 8 Finally, family opinion had a profound influence on different themes would be identified in younger versus CCT decision-making. The majority of AYA involved older AYAs. Not unexpectedly, stage of disease appeared their family in the CCT decision-making process, and to have interplay with CCT acceptability. As a follow on perceived their role as supportive in terms of helping from this study, we are currently investigating CCT de- them to seek and interpret trial information and make a cision making stratified per age group and its interplay decision. However, some participants experienced family with relevant psychosocial, relational influences and as an undue influence, particularly when loved ones stage of disease. In addition, this study was limited to undermined their autonomy or capacity to fully reflect understanding the experiences of AYA who were receiv- on their values and determine a course of action. ing care at one adult urban comprehensive cancer Shared decision-making is a care delivery model en- centre. Future research could involve AYA who are re- couraged by the American and Canadian Pediatric Soci- ceiving care at community-based cancer settings. eties [39, 40]. A recent review identified that adolescents and parents prefer partnership and cooperation as op- Conclusion posed to complete independence in decision making To our knowledge, this is one of only a few studies about cancer treatments, clinical research, and examining CCT perceptions of AYA at an adult cancer end-of-life decisions [41]. In fulfilling our ethical and center aimed at identifying barriers to trial enrolment professional obligations, it should not be assumed that and enabling supportive decision-making. Several over- every AYA wants to involve their family in decision mak- arching themes regarding important factors and contexts ing to the same extent or in the same way. AYA encom- that influence AYA CCT decisions were identified. Spe- pass a wide age range including adolescents aged 15 to cific strategies may include providing opportunity for pa- mature adults aged 39. For those who are capable, pro- tients to involve family in decision-making and assisting viders should seek direction from AYA about who con- AYA in appreciating short- and long-term implications stitutes ‘family’, and the level of involvement they prefer of CCT participation. Finally, exploring social network- their family to have [39]. Furthermore, AYA retain the ing/online forums and general education about CCT moral and oftentimes legal right to decline CCT partici- that AYA can independently access, may increase their pation. In a partnership model, AYA should not be pres- willingness to participate. sured to accept CCT participation against their will or solely on the basis of their parents’ wishes. Additional file A Cochrane review identified interventions to promote participation in shared medical decision making for chil- Additional file 1: Table S1. Interview guide is presented in the additional file. (DOCX 17 kb) dren with cancer [42]. These interventions included healthcare professional training, and implementation of Abbreviations patient-mediated interventions including decision aids. AYA: Adolescent and Young Adult; CCT: Cancer Clinical Trial; QOL: Quality of Although not specifically targeted to AYA, some of these life strategies may be tailored for AYA and evaluated within Availability of data and materials the clinical research setting. Other communication strat- The datasets used and analysed during the current study are available from egies to improve collaboration between physicians, pa- the corresponding author on reasonable request. tients and family may also be employed with a goal of evaluating these strategies. Authors’ contributions JL, AG, JB and LM designed the research. JB, VF, ST and KW acquired the Many AYA used the internet as a primary source for data including baseline demographics and interviews. All authors were in obtaining additional trial information. Current trial data- charge of data analysis and final approval of the manuscript. bases meant to provide information to patients could be Ethics approval and consent to participate enhanced for AYA [43]. For example, these websites We declare that this study was approved by the research ethics board could explore the integration of trial information with of Princess Margaret Cancer Centre prior to study commencement online media, social networking sites and online forums (CAPCR 16-5376). All patients signed a written informed consent. as a space for CCT education to enhance AYA know- Competing interests ledge about trials and potentially increase accrual. The authors declare that they have no competing interests. We acknowledge several limitations to this study. First, AYA include a wide age range and developmental stages. 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Attitudes toward cancer clinical trial participation in young adults with a history of cancer and a healthy college http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png BMC Cancer Springer Journals

Perceptions of and decision making about clinical trials in adolescent and young adults with Cancer: a qualitative analysis

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Biomedicine; Cancer Research; Oncology; Surgical Oncology; Health Promotion and Disease Prevention; Biomedicine, general; Medicine/Public Health, general
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Abstract

Background: Adolescent and young adults (AYA) enrolment rates into cancer clinical trials (CCT) are the lowest of any age group globally. As AYA have distinct biological, psychosocial and relational needs, we aimed to explore any unique factors influencing their CCT decision-making process, including AYA-specific perceptions or attitudes towards CCT. Methods: Qualitative interpretive descriptive methodology was used to explore AYA perceptions and decision-making related to CCT. An analytic approach conducive to inductive imagining and exploratory questioning was used in order to generate insights and interpret data. Results: A total of 21 AYA were interviewed (median age: 31 (18–39)). Twelve (57%) participants had previously been approached to participate in CCT. Major themes influencing trial enrolment decisions were: 1) severity of illness/urgency for new treatment 2) side effect profile of investigational drug in the short and long term (e.g., impact on future quality of life) 3) who approached patient for trial participation (oncologist vs. other) 4) additional information found on-line about the trial and investigators, and 5) family, friends and peer group opinion regarding the CCT. Conclusions: Several psychosocial and relational factors were identified as influencing AYA CCT decisions, some of which are unique to this demographic. Specific strategies to address barriers to CCT and enable supportive decision-making include: 1) involving family in decision-making and 2) helping AYA appreciate short- and long-term implications of trial participation. Finally, exploring social networking and general education about CCT that AYA can independently access may increase participation. Keywords: Adolescent and young adult, Attitudes, Barriers, Cancer, Clinical trial, Beliefs, Psychosocial, Perception Background research [3, 4], predominantly related to investigating sys- Adolescents and young adults (AYA), aged 15 to 39 years, tem and regulatory barriers impacting access [5]. Examin- represent a unique subset of cancer patients. With over ation of perceptions and attitudes towards CCT, also 70,000 AYAs diagnosed with cancer in the United States known to impact trial participation, has been limited to annually, and 7600 diagnosed in Canada, this group repre- children/AYA in pediatric institutes [6–8], older adults [9, sents approximately 4–5% of the North American adult 10] and other marginalized populations [11], with few cancer population [1–3]. Lack of enrolment of AYA onto studies focusing specifically on AYA treated in adult can- cancer clinical trials (CCT) has been the focus of much cer centers. CCT enrolment decisions are influenced by a variety of factors including altruism, scientific benefit, recom- mendations from medical personnel [12–14] and belief * Correspondence: abha.gupta@sickkids.ca Abha A. Gupta and Jeremy Lewin contributed equally to this work. that CCT offers the best treatment [15]. Potential bar- Adolescent and Young Adult Program, Princess Margaret Cancer Centre, riers to CCT enrolment include lack of trial awareness Toronto, Canada [16], concern about side effects [10, 17], medical mis- Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada trust, including fear of being a guinea pig [11, 18], Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Bell et al. BMC Cancer (2018) 18:629 Page 2 of 8 protocol stringency [10], belief that risks outweigh bene- identified potential participants during their regular out- fits [14], concern regarding potential conflicts of interest patient clinics and made initial contact with them regarding [19] and lack of trial availability or opportunity to par- the study. Those patients who were interested in learning ticipate [16]. However, there is limited information about more were referred to two members of the study team (VF the role that personal, socio-demographic characteristics, (female, medical student); ST (female, nursing student)) with and other factors might play in the acceptability of CCT whom the patients did not have any previous clinical rela- for AYA [7, 8, 20–25]. AYA CCT enrolment decisions tionship. These study team members provided a thorough occur in the context of cognitive and emotional develop- background of the study and patients were given as much ment/growth, and self-identity maturation. As a result, it time as they needed to consider the study information and is likely that unique psychosocial and relational factors provide informed consent or refusal to study participation. place additional stress on and influence their CCT Prior to the interview, participants were asked to decision-making process [26]. Thus, this study aimed to complete a demographics form. Participants were given investigate AYA-specific perceptions or attitudes to- the option to conduct the interview at the current time, wards CCT in an adult comprehensive cancer centre or to schedule an interview time in the future. Patients and explore additional factors that may influence AYA who participated in an interview were given a $10 gift decision-making about CCT. card for their time. Methods Data collection Study design Semi-structured face-to-face interviews were conducted Qualitative interpretive descriptive methodology was with each participant in a private setting at the hospital. used [27]. This discovery-oriented approach allows for a All participants individually engaged in the interview but process whereby the researchers remain open to deriving out of respect for the preferences and desires of some insights from the data in order to inform understandings AYA participants, a family member or friend was that answer questions relevant to clinical practice [28]. allowed to be present during the interview to support To do so, in-depth exploration of participants’ experi- them. In these cases, the family member or friend ences is sought with the aim of identifying thematic pat- quietly observed the interview and only a few interjected terns and commonalities, while simultaneously occasionally to give additional information that the par- accounting for individual variation [27]. The overarching ticipant had missed about a certain event or in re-telling goal of interpretive description within this study was to a story. Most of the time the family member or friend identify clinically relevant insights to support AYA deci- was silent. sion making and enhance trial participation. The study An investigator-developed interview guide was created was conducted through the AYA Program at Princess to explore participants’ understanding of CCT, trial expe- Margaret Cancer Centre, Canada [29, 30]. Research eth- riences, factors that influence their decision-making about ics board approval was obtained prior to study com- trial enrolment, and AYA-specific perceptions or attitudes mencement (CAPCR 16-5376). Participants completed towards CCT (see online Additional file 1: Table S1). The written informed consent generally within 24 h of being guide was influenced by previous literature on the barriers approached and prior to any study procedures. They to CCT as experienced by other populations while allow- were reminded of their right to withdraw from study ing for open-ended responses. The research team participation at any time without affecting their care. reviewed the guide to ensure that questions were all-encompassing and contained the necessary probes to Sampling and recruitment help facilitate informative responses. Participants were Eligibility criteria for participants included: patients aged conveyed a working definition of CCTs as defined by the 15 to 39 years upon cancer diagnosis; currently receiving National Institute of Health [31]. Preliminary interviews cancer care (active or in surveillance); and ability to en- were conducted and analyzed to further refine the inter- gage in an interview. Those unable to speak English, or view guide in terms of applicability, ease of use, and effi- who had severe cognitive impairment that would limit ciency. Interviews were conducted with one of two their participation were excluded. Patients with investigators (VF and ST) under the guidance of a mem- leukemia, lymphoma, sarcoma, breast and testes cancer ber of the research team (JB), who has extensive experi- were purposefully recruited with diverse backgrounds ence and training in conducting qualitative interviews. with respect to age, clinical trial experience (accept, Interviews were digitally recorded and transcribed verba- decline, or neither) and treatment goals (metastatic or tim by the researchers (VF and ST). The duration of the disease free). interviews was variable (between 30 min to an hour and a The principal investigators (AG (female, oncologist); JL half). Transcripts were not returned to participants for (male, oncologist)) who were part of the circle of care comment. Bell et al. BMC Cancer (2018) 18:629 Page 3 of 8 Data analysis related to each theme were purposefully sought in order Qualitative data analysis exists on a spectrum of data to understand individual variation and to provide a more transformation from description to interpretation [32]. comprehensive perspective of the collective experience. Because our research aimed to inform clinical practice change, an analytic approach closer to description was Results used in order to generate insights and interpretation of Twenty-three AYA were approached to participate in the interview data related to the research objective [27]. the qualitative interviews between June and August, Two members of the research team (VF, ST) independ- 2016. Of the 23 AYA approached, 21 consented to par- ently reviewed three interview transcripts with the intent ticipate. Eight AYA participant interviews included their of developing “broad-based” codes (as opposed to family member or friend. Participant characteristics are line-by-line coding) ([27], p., 160). These codes were re- shown in Table 1. The median age of participants was 31 flective of those ideas, words or phrases identified as (18-39). Twelve (57%) participants had been approached relevant to the research aim. Broad-based or generic to participate in CCT of which 10 (48%) had enrolled. codes allowed the researchers to remain open to the ut- The majority of these participants (N = 9; 90%) had en- terances and meanings within the data so that they rolled at the time of recurrence or during treatment for might be further interrogated and allow for interpretive metastatic disease. thinking [27]. The researchers then met to compare and contrast codes with a third member of the research team Major themes (JB), and to establish inter-coder reliability. Consensus Major themes were categorized into positive, negative was reached between team members (VF, ST, JB) on the and neutral influences on CCT participation as guided creation of new codes or the collapsing of data into by the research objective (Fig. 1). Positive influences en- existing codes, and the building of detailed descriptions abled CCT participation, negative influences detracted to form an initial coding framework. The initial coding from CCT participation, and neutral influences either framework was then applied independently by each re- had no effect on CCT participation or were described by searcher (VF, ST, and JB) to four more transcripts. The participants as supportive of their trial decision-making researchers (VF, ST, and JB) met again to discuss any process. The top five most frequent thematic influences discrepancies in codes and in applying the initial coding on AYA decision-making regarding CCT participation, framework. Based on this discussion, the initial coding as identified in ≥90% of participant interviews, were: se- framework was modified and distributed to the entire re- verity of illness/urgency of treatment, influence of side search team for review. After review and approval, the effects, recruitment method, additional information, and coding framework was applied by the researchers (VF, opinion of others (Table 2). ST) to the remaining transcripts. Codes were continually compared between and among transcripts as the re- Positive influences on CCT participation searchers asked questions of the data such as “how im- portant is this experience to AYA decision making?” and Severity of illness/urgency of treatment Severity of ill- “is this code qualitatively different than that code?” [28]. ness/urgency of treatment was discussed by a majority of Further, potential relationships between identified codes those interviewed, and was identified by participants as a were explored in order to inform a cohesive and positive influence on AYA’ willingness to participate in clinically-relevant account of influences on AYA CCT CCT. Most AYA stated they would enrol in a trial out of decision making [27]. desperation if they had not responded effectively to the The generation of major themes was guided by a for- standard treatment available and their disease was pro- mal code repetition analysis whereby one member of the gressing or in an advanced stage. As reported by one research team used standard word processing software participant, age 38 (disease free, never been offered a (Microsoft Word) to count the number of times each trial), “If I’ve been given a bad prognosis […] I would code was identified in the transcripts [33]. This exercise probably be willing to participate [in a clinical trial], be- served as a proxy for presumed importance of the ex- cause maybe this new drug might help me”. Similarly, a perience. Major themes were identified as those codes, 36 year-old participant (metastatic disease, currently en- ideas or experiences that had the most textual support rolled on a clinical trial) stated, “I don’t have another op- from multiple transcripts. To promote trustworthiness tion. Radiation is not an option, surgery is not an of the findings [34], major themes were reviewed by the option, so [a clinical trial] is what I’ve got”. Only one entire research team and compared and contrasted with participant said that they would have enough options previous literature on CCT participation in diverse pop- available so that CCT would not be worth their while. ulations as well as the clinical experience of the Another participant did not mention severity of illness/ clinician-investigators. In addition, alternate perspectives urgency as a concern. Bell et al. BMC Cancer (2018) 18:629 Page 4 of 8 Table 1 Participant Characteristics Total participants (n, %) 21 Age, Median (Range) 31 (18-39) Gender Male 10 (48) Female 11 (52) Cancer Diagnosis Testes 3 (14) Leukemia 3 (14) Lymphoma 6 (29) Breast 3 (14) Sarcoma 6 (29) Previous Trial Involvement Approached regarding CCT 12 (57) Phase I 2 (10) Phase I/II 3 (14) Phase II 3 (14) Phase III 4 (19) Not Approached regarding CCT 9 (43) Enrolled on CCT 10 (48) Enrolled at time of diagnosis 1 (5) Enrolled at time of recurrence or during 9 (43) treatment for metastatic disease. English as first language Yes 18 (86) No 3 (14) Student and employment status Currently Working 6 (29) Working prior to diagnosis 13 (62) Currently at School 3 (14) Completed university degree Yes 14 (67) No 7 (33) Children Yes 9 (43) No 12 (57) Mean no. of dependent children 1.3 Relationship Status Single 4 (19) In a Relationship 8 (38) Married 9 (43) Negative influences on CCT participation participant was concerned only if side effects had a high probability of occurrence. Other participants believed Trial side effects Influence of side effects was discussed that CCT offered the best chance of cure so they would in most of the interviews. This theme referred to consid- endure any side effects, or they downplayed the signifi- erations of how the experience of drug side effects cance of side effects, perceiving they would be easily would influence CCT participation. Participants per- treated while on trial. Approximately half of participants ceived the possibility of trial side effects in diverse ways. stated that long-term or severe side effects were quite It could either act as a deterrent towards enrolling, or it concerning and that they would need to thoroughly con- was described as having little to no effect on a patient’s sider their participation prior to enrolment. These par- decision to enrol. Over half of participants stated they ticipants stated the need to weigh the potential for side would consider side effects prior to enrolling in a clinical effects to impact their future quality of life (QOL) trial, while only a few participants said side effects were against the therapeutic gains from the trial. One 23 year-- not a major concern. Several participants stated they old participant (metastatic disease, currently enrolled on had no other treatment options available so they would a trial) mentioned that, “If [the side effects were] some- try any treatment regardless of side effects; one thing like numbness [..] I would still go through with Bell et al. BMC Cancer (2018) 18:629 Page 5 of 8 Fig. 1 A total of 35 themes were identified as influencing AYA patient decisions regarding enrollment in CCT. These themes were classified as either positive, negative or neutral influencers affecting AYA clinical trial enrollment [the clinical trial] because my options are getting smaller decision to enrol or not. This theme included partici- as more regimens are not working for me. But if it was pants’ preferred method of being approached about a something pretty serious I would explore my options be- trial (through email, in-person, or over the phone) along sides this”. When separated by stage of disease, five of with the timing of approach and from whom they would six patients without active disease shared concerns re- prefer to hear about a clinical trial for the first time (e.g. garding long-term side effects from CCT as opposed to from an oncologist, nurse or member of the research eight of 15 for those with metastatic disease. team). More than half of participants said they preferred their Neutral influences on CCT participation oncologist to initiate a trial conversation, while the remaining were ambivalent as long as they had the ne- Recruitment method Recruitment method was de- cessary information to answer any questions they might scribed in all of the interviews. This was a general theme have about the trial. There was no consensus regarding used to encompass descriptions of how trial personnel the preferred timing of being offered a trial or how re- had approached AYA patients about trial participation, cruitment should be initiated, although some partici- and reflections on how this might influence their pants thought they should only be approached about a Table 2 Five prevalent themes influencing AYA decision making were identified in ≥90% of participants Theme Theme Example Classification Positive Severity of illness/urgency (95%) “I brought up side effects a few times, but if there weren’t really any options or the current options weren’t working and my team was at a loss of what to do. I don’t see that I would have a choice.” Negative Concern about side effects (90%) “Yes, it would. Permanent side effects? No thanks. The side effects I’ve already been having with chemo are harsh enough... definitely side effects would be huge thing” Neutral Recruitment method (100%) “I was approached very nicely and academically and they gave me the right information. I was able to meet a lot of different professionals working on the trial and felt confident because I got a lot of different perspectives by different teams.” Additional information (95%) “I like that I was able to talk about it with my doctor… I know ultimately I make most of the decisions for myself but I hold him in very high regard.” Opinion of others (100%) “My friends and family are very informed and aware of what is going on with me. Always want to come to the hospital and they all do their own research…It’s great, I am very supported.” Bell et al. BMC Cancer (2018) 18:629 Page 6 of 8 trial if their standard treatment was not working. Add- understand the barriers to trial participation. In this itionally, participants believed an offer of trial participa- study of AYA at a large adult comprehensive cancer tion should not be extended to patients who had just centre, several overarching themes were identified re- been diagnosed, thinking these patients would be too garding psychosocial and relational factors influencing overwhelmed or not in a stable state of mind to receive AYA CCT decisions, some of which are unique to this further information about clinical trials. demographic. Many AYA were concerned about both short- and Additional information long-term side effects and outcomes of CCT on their fu- Seeking additional information was discussed in most of ture QOL. Of note, we did not specifically probe partici- the interviews. This theme related to the role additional pants as to whether the toxicity concerns were in information played in participants’ decisions about CCT addition to standard of care drugs (which are often the participation. Almost all participants reported conduct- comparator arm of many CCT) that often carry their ing online research for published studies or gathering own side effect profile. Although drug side effects are a more information about the protocol and study investi- factor in adult cancer patient trial decisions [10, 35], the gators. A few participants sought a second opinion from priority AYA place on longer-term implications appear an oncologist who was not their primary physician for to be unique to this cohort. Hope for longevity likely in- more information or to explore additional treatment op- fluences AYA’ concerns about the long-term impacts of tions. Two participants said they would try to contact an investigational agent on future QOL. Whereas older previous clinical trial participants to obtain their per- adults may perceive themselves as having lived a signifi- spectives and experiences in order to inform their deci- cant proportion of their lives, and focus on giving back sion making. to others through trial participation [12–24], our find- ings suggest AYA’ future-oriented considerations may be Opinions of others closely intertwined with stage of disease and consider- Opinions of others was described in all of the interviews. ations of what is best for one’s self in making a trial deci- This theme related to the ways in which the opinions of sion. This emergent finding may have important family members or friends influenced the clinical trial implications for how trials might generally be promoted decision. The majority of participants said that family or discussed with AYA. For example, public advertise- would be involved in the clinical trial decision-making ments emphasizing the benefit of helping others may process by helping them to make a decision, supporting not be as relevant for AYA [36]. their search for more information about the trial, or Another central theme we identified is method of re- helping them to stay informed about the clinical trial cruitment. Participants indicated they would not want to process throughout recruitment and study participation. be approached for a CCT if they had just been diagnosed Only one participant excluded family in the clinical trial or were otherwise overwhelmed with their treatment decision. This 28 year-old female explained that she course. Distress or uncertainty has been identified as a made the decision to enrol in a CCT immediately after detractor of decision-making ability in a wide range of the doctor offered the option due to its high success treatment contexts [37]. Previous literature has demon- rate. She stated that her only other treatment options strated that adolescents between the ages of 14-18 years would not offer a chance for a full recovery, so the CCT may have greater difficulty self-regulating their emotions was the best option. Two participants stated that family in response to a life-threatening illness [38], which may pressured them with regards to clinical trial participation make managing their distress in the context of trial as opposed to simply offering their opinion. A 21 year-- decision-making even more challenging. Our findings old patient (metastatic disease, had previous clinical trial suggest an important role for professionals to respond to experience) explained how her father hurried her deci- AYA psychological needs, and a CCT recruitment ap- sion and encouraged her to participate based on altruis- proach that encourages their capacities to make an in- tic reasons. “[From] my dad, I think it was a bit more of formed trial decision. For example, approaching AYA pressure to join the trial […]. If I were alone I would’ve about a study using simplified age-appropriate language, thought about it for a little bit longer, and maybe I acknowledging their emotions and offering further sup- wouldn’t have done it”. She stated her father “pushed” port/resources tailored to their situation, and addressing her into enrolling in a clinical trial, as it would be “great any practical barriers to CCT participation (e.g., child for research” and “improve the outcome for others.” care, transportation). In this study, AYA preferred their oncologist to introduce them to a trial rather than an in- Discussion dependent trial nurse. As such, educating oncologists in As AYA enrolment rates into CCT are the lowest of any adult cancer services of the unique needs of AYAs may age group globally, a major focus of recent research is to aid in recruitment onto CCT. Bell et al. BMC Cancer (2018) 18:629 Page 7 of 8 Finally, family opinion had a profound influence on different themes would be identified in younger versus CCT decision-making. The majority of AYA involved older AYAs. Not unexpectedly, stage of disease appeared their family in the CCT decision-making process, and to have interplay with CCT acceptability. As a follow on perceived their role as supportive in terms of helping from this study, we are currently investigating CCT de- them to seek and interpret trial information and make a cision making stratified per age group and its interplay decision. However, some participants experienced family with relevant psychosocial, relational influences and as an undue influence, particularly when loved ones stage of disease. In addition, this study was limited to undermined their autonomy or capacity to fully reflect understanding the experiences of AYA who were receiv- on their values and determine a course of action. ing care at one adult urban comprehensive cancer Shared decision-making is a care delivery model en- centre. Future research could involve AYA who are re- couraged by the American and Canadian Pediatric Soci- ceiving care at community-based cancer settings. eties [39, 40]. A recent review identified that adolescents and parents prefer partnership and cooperation as op- Conclusion posed to complete independence in decision making To our knowledge, this is one of only a few studies about cancer treatments, clinical research, and examining CCT perceptions of AYA at an adult cancer end-of-life decisions [41]. In fulfilling our ethical and center aimed at identifying barriers to trial enrolment professional obligations, it should not be assumed that and enabling supportive decision-making. Several over- every AYA wants to involve their family in decision mak- arching themes regarding important factors and contexts ing to the same extent or in the same way. AYA encom- that influence AYA CCT decisions were identified. Spe- pass a wide age range including adolescents aged 15 to cific strategies may include providing opportunity for pa- mature adults aged 39. For those who are capable, pro- tients to involve family in decision-making and assisting viders should seek direction from AYA about who con- AYA in appreciating short- and long-term implications stitutes ‘family’, and the level of involvement they prefer of CCT participation. Finally, exploring social network- their family to have [39]. Furthermore, AYA retain the ing/online forums and general education about CCT moral and oftentimes legal right to decline CCT partici- that AYA can independently access, may increase their pation. In a partnership model, AYA should not be pres- willingness to participate. sured to accept CCT participation against their will or solely on the basis of their parents’ wishes. Additional file A Cochrane review identified interventions to promote participation in shared medical decision making for chil- Additional file 1: Table S1. Interview guide is presented in the additional file. (DOCX 17 kb) dren with cancer [42]. These interventions included healthcare professional training, and implementation of Abbreviations patient-mediated interventions including decision aids. AYA: Adolescent and Young Adult; CCT: Cancer Clinical Trial; QOL: Quality of Although not specifically targeted to AYA, some of these life strategies may be tailored for AYA and evaluated within Availability of data and materials the clinical research setting. Other communication strat- The datasets used and analysed during the current study are available from egies to improve collaboration between physicians, pa- the corresponding author on reasonable request. tients and family may also be employed with a goal of evaluating these strategies. Authors’ contributions JL, AG, JB and LM designed the research. JB, VF, ST and KW acquired the Many AYA used the internet as a primary source for data including baseline demographics and interviews. All authors were in obtaining additional trial information. Current trial data- charge of data analysis and final approval of the manuscript. bases meant to provide information to patients could be Ethics approval and consent to participate enhanced for AYA [43]. For example, these websites We declare that this study was approved by the research ethics board could explore the integration of trial information with of Princess Margaret Cancer Centre prior to study commencement online media, social networking sites and online forums (CAPCR 16-5376). All patients signed a written informed consent. as a space for CCT education to enhance AYA know- Competing interests ledge about trials and potentially increase accrual. The authors declare that they have no competing interests. We acknowledge several limitations to this study. First, AYA include a wide age range and developmental stages. 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BMC CancerSpringer Journals

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