Background: Physical activity (PA) programmes effective under ‘research’ conditions may not be effective under ‘real-world’ conditions. A potential solution is to refer patients to existing PA community-based PA services. Methods: A process evaluation of referral of post-surgical patients with early-stage breast cancer to cardiac rehabilitation exercise classes, leisure centre with 3-month free leisure centre membership or telephone-delivered PA consultations for 12 weeks. Quantitative data were collected about PA programme uptake and reach, patient engagement with the PA programme, delivery and fidelity and PA dose. Qualitative data were collected about patient experiences of taking part in the PA programmes. Audio-recorded qualitative interviews of participants about the programmes were analysed thematically. Quantitative data were reported descriptively using means and SD. Results: In Phase I, 30% (n = 20) of eligible patients (n = 20) consented, 85% (n = 17) chose referral to leisure centre, and 15% (n = 3) chose cardiac rehabilitation. In Phase II, 32% (n = 12) consented, 25% (n = 3) chose leisure centre and 75% (n = 9) chose telephone-delivered PA consultations. Walking at light intensity for about an hour was the most common PA. All Phase I participants received an induction by a cardiac rehabilitation physiotherapist or PA specialist from the leisure centre but only 50% of Phase II participants received an induction by a PA specialist from the leisure centre. Four themes were identified from qualitative interviews about programme choice: concerns about physical appearance, travel distance, willingness to socialise and flexibility in relation to doing PA. Four themes were identified about facilitators and barriers for engaging in PA: feeling better, feeling ill, weight management, family and friends. Conclusions: The current community-based PA intervention is not yet suitable for a definitive effectiveness randomised controlled trial. Further work is needed to optimise PR programme reach, PA dose and intervention fidelity. Trial registration: ISRCTN11183372. Keywords: Breast cancer, Health behaviour, Complex intervention, Physical activity, Cancer survivorship, Rehabilitation * Correspondence: email@example.com Department of Nursing, University of the Highlands and Islands, Centre for Health Sciences, Old Perth Road, Inverness IV2 3JH, Scotland, UK 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. Hubbard et al. Pilot and Feasibility Studies (2018) 4:108 Page 2 of 14 Background leisure centres and personal trainers for the general pub- Breast cancer is the most common cancer among lic. If people with breast cancer are offered a choice of women worldwide, with an estimated 1.67 million new these existing PA programmes, they may perceive cancer cases diagnosed in 2012 (25% of all cancers) . increased control over their options and as proposed by In the United Kingdom (UK), three quarters of the most social cognitive models of human behaviour, 53,696 people diagnosed with breast cancer each year offering choice will improve motivation to change be- survive for at least 10 years . Consequently, research haviour [18, 19]. concerning the longer-term psychosocial and physical Cardiac rehabilitation, which is widely available health of people treated for breast cancer is important. throughout the UK and in other countries, includes su- An increasing body of evidence has linked pervised circuit classes for people recovering from cor- post-diagnosis physical activity (PA) to length and quality onary heart disease. A core component of cardiac of breast cancer survivorship, with results summarised in rehabilitation is PA and exercise so that people recover- meta-analyses and systematic reviews [3–6]. Benefits of ing from cardiovascular disease increase overall daily en- PA include improvements in cardiorespiratory fitness, ergy expenditure to achieve good cardiovascular health body composition (including muscle mass and bone . A British Heart Foundation audit found that at health), strength and flexibility, body image, self-esteem, 12 months after participation in cardiac rehabilitation mood, stress, depression, anxiety, nausea, fatigue and pain. there was a 14 percentage point increase in the number Fear of recurrence is one of the main causes of distress in of people exercising five or more times a week for cancer survivors  but PA trials have not examined if be- 30 min and a 23 percentage point reduction in those ing active addresses these fears. Professional bodies in dif- who rarely/never took exercise . Current guidelines ferent countries, including the UK, have published for cardiac rehabilitation recommend use of generic detailed PA prescription guidelines for people with cancer evidence-based behaviour change techniques (BCTs) to [8–12]. These bodies concur that unless advised other- support improvement in PA such as motivational coun- wise, all cancer survivors should aim to meet national PA selling (active listening skills, empathy and open ques- recommendations for the general public (currently ≥ tioning), goal setting and instructing/coaching . 150 min of moderate intensity aerobic activity per week, Hence, cardiac rehabilitation exercise classes using BCTs plus two sessions of muscular strength and endurance and could also be relevant to people with cancer to increase some daily flexibility/balance exercises). A concern for PA. A core component of cancer rehabilitation is PA breast cancer clinical teams is that only 16% of breast can- and exercise [8–12], and a recent study suggests that cer survivors are meeting PA recommended guidelines referral of people with colorectal cancer to cardiac re- , and sedentary time remains high in the first year habilitation exercise classes is feasible and acceptable following treatment for breast cancer . Therefore, pa- . Referral to cardiac rehabilitation exercise classes of tients need effective evidence-based programmes to sup- people with breast cancer, however, has not been previ- port them to increase PA. ously investigated. To date, the majority of PA trials in cancer have evalu- Another existing PA service is exercise referral ated interventions under research (e.g. group exercise schemes (ERS) . Most ERS operate out of commu- class led by a researcher) rather than ‘real-world’ settings nity leisure centres to provide health coaching, exercise . Yet, PA programmes that are effective under re- consultations, motivational interviews, community-based search conditions are not translated in practice and PA gym and exercise classes, walking and/or gardening ac- programmes are not routinely part of the standards of tivities. ERS are highly heterogeneous but typically in- care provided to people following a cancer diagnosis volve health professional referral of a patient to a leisure . An advantage of using existing community-based centre, agreement of a PA programme with a leisure PA services is that an infrastructure already exists but centre instructor and discounted access to the leisure should only be recommended if there is evidence that centre for 10 to 12 weeks . A review of eight rando- they are clinically effective and uptake in the target mised controlled trials of ERS found an increased num- population will be high. Determining if existing ber of participants who achieved 90–150 min of PA of at community-based PA services are likely to be used by least moderate intensity per week (pooled relative risk people with cancer to aid their recovery is especially 1.16, 95% confidence intervals 1.03 to 1.30) compared relevant in the UK where one of the leading cancer char- with controls . It remains unclear if similar increases ities is rolling out a national ‘physical activity offer’ to in PA could be achieved in people with breast cancer re- people recovering from cancer that includes use of exist- ferred to a similar scheme. ing community services . There are a range of exist- Travel and distance is a barrier to attending PA exercise ing PA services including cardiac rehabilitation exercise classes for people recovering from treatment for breast classes for people with coronary heart disease, and cancer . Cardiac rehabilitation exercise classes and Hubbard et al. Pilot and Feasibility Studies (2018) 4:108 Page 3 of 14 leisure centres may not be easily accessible to some people In addition to quantifying patient engagement and prac- with cancer because they live in remote and rural areas. titioner delivery, understanding patients’ motivations However, PA specialists located in leisure centres could and barriers to PA will also help in the design of more potentially deliver telephone-based consultations and, in effective interventions [25, 33]. This paper focuses on doing so, offer the unique advantages of increased con- the following study’s objectives: (1) quantify PA venience and access [28, 29]. A recent systematic review programme uptake and reach, patient engagement with identified seven studies of telephone-delivered PA pro- the PA programme, PA programme delivery and fidelity grammes for people with breast cancer, with evidence of a and PA dose and (2) qualitatively explore patient experi- small to moderate effect on quality of life . However, ences of taking part in the PA programmes. There is lack the review identified only two studies including people of consensus about reporting the effectiveness of inter- with breast cancer who were on adjuvant treatment, and ventions in preliminary work conducted before a full de- hence, it remains uncertain if patients on treatment for finitive trial . In this paper we do not report breast cancer would engage with this type of PA outcomes because we did not include a control group to programme. Motivational interviewing was used in several evaluate intervention effects, and the study was not of the studies included in the review . Motivational powered to determine meaningful differences in health interviewing is recognised as a useful translation of outcomes pre- and post-intervention. self-determination theory (SDT) . According to SDT, conditions that support a person’s basic psychological Methods needs, which is their need for ‘autonomy,’ (feeling of being Design the origin of behaviour), ‘competence’ (feeling of being ef- The study was conducted in two phases. In Phase I, the fective) and ‘relatedness’ (feeling of being understood and referral of patients to cardiac rehabilitation exercise clas- cared for by others), foster the most volitional and intrin- ses or to the local leisure centre with 3-month free sic forms of motivation for initiation and long-term main- membership was investigated. Phase I findings were used tenance of health behaviours including PA . A to inform which PA programmes would be included in growing body of empirical work has shown that Phase II. In Phase I, travel and distance was the most SDT-based interventions are effective in augmenting common reason why eligible patients were not willing to changes in level of PA , but SDT-based interventions participate in the study. In Phase II, we aimed to im- have rarely been tested in ‘real-world’ conditions or in prove intervention reach by removing this barrier to people with cancer. participation. Hence, in Phase II, we included the referral of people after surgery for breast cancer to Aims telephone-delivered PA consultations. In Phase I, the In this paper, the findings of a mixed methods process majority of participants chose referral to the leisure evaluation of a PA intervention for people after surgery centre with 3-month free membership so we only for breast cancer is reported. The main aim of the study included this PA programme in Phase II. We did not was to understand if referral of people after surgery for include a comparison group such as a usual care group breast cancer to the following existing community-based to act as a control group in either Phase I or II because PA services—cardiac rehabilitation exercise classes, the the main aim of the study was to gather evidence about local leisure centre with 3-month free membership, or to the implementation of the three different PA pro- telephone-delivered PA consultations—is feasible to im- grammes in practice. plement and if these PA programmes are acceptable to people with breast cancer. Medical Research Council Setting guidance about process evaluation of complex interven- Recruitment took place over 6 months in Phase I and tions highlights the importance of investigating how in- 3 months in Phase II at one UK hospital serving an urban terventions are delivered by practitioners and how and rural population. The three different PA programmes patients engage with interventions as a means of under- (cardiac rehabilitation exercise class, leisure centre with standing the implementation and functioning of the 3-month free membership, telephone-delivered PA intervention in practice . PA interventions are often consultations) were delivered by local practitioners (either poorly described, yet explicit reporting of what actually health professional delivering the local cardiac rehabilita- happens in a PA intervention is essential to the inter- tion exercise classes or PA specialists from the local pretation, translation and implementation of research leisure centre). findings into clinical practice . These types of evi- dence are particularly useful when an intervention fails Intervention to achieve intended theorised effects because it may be Phase I participants were referred to either a local car- explained by lack of engagement or poor delivery . diac rehabilitation exercise class or to a local leisure Hubbard et al. Pilot and Feasibility Studies (2018) 4:108 Page 4 of 14 centre with 3-month free membership depending on an individual PA programme, including goal setting. participant choice. Phase II participants were referred to After the face-to-face induction, there were no mandatory a local leisure centre or to telephone-delivered PA con- consultations with a leisure centre PA specialist during sultations that were delivered by a PA specialist from the the remaining 12 weeks of the PA programme. PA special- leisure centre depending on participant choice. As ex- ists were qualified to Register of Exercise Professionals plained above, the cardiac rehabilitation exercise class (REPs) Level 4 in Cancer and Exercise (www.canrehab. was not offered in Phase II because few participants co.uk) and had attended an additional 1-day educational chose this PA programme in Phase I. A logic model for course delivered by a cancer and exercise specialist (AC) the intervention, which was informed by the research about PA for people recovering from breast cancer for the team’s previous work, such as the use of cardiac rehabili- purposes of the study. In Phase II only, participants were tation in colorectal cancer patients , discussions with also given a pedometer (2D G-sensor) to monitor step local PA service providers, the local breast cancer care count each day. team and the literature is available in Additional file 1. Telephone-delivered PA consultations Cardiac rehabilitation exercise class PA specialists were the same people who were delivering Participants were referred to an existing cardiac rehabili- the leisure centre with 3-month free membership PA tation exercise class. The cardiac physiotherapist in- programme described above. Participants initially met formed the research team that the British Association of face-to-face with a PA specialist at the leisure centre for Cardiovascular Prevention and Rehabilitation (BACPR) PA induction. At induction, participants received a guidelines were followed when delivering the exercise health check by completing the PAR-Q  and an indi- classes including goal setting and use of motivational vidual exercise programme was planned. During the interviewing techniques . At a face-to-face induction remaining 12 weeks of the PA programme, participants with a cardiac rehabilitation physiotherapist, participants had a weekly telephone-delivered PA consultation with were given an initial fitness assessment with incremental the PA specialist. All PA consultations were conducted shuttle walk test. Specific exercises and intensities that in accordance with self-determination theoretical (SDT) the participant was to do in the class were discussed at techniques  (see Table 1 for list of techniques). The induction. Participants attended a 1-h cardiac rehabilita- PA specialists had attended a 1-day education event de- tion circuit exercise class in a gym at the local hospital livered by a health psychologist (WM) about motiv- once a week for 12 weeks. A cardiac physiotherapist and ational interviewing, which is recognised as a useful a physiotherapy assistant delivered the class. Exercise translation of SDT [30, 39]. Participants were also given took place in a group setting alongside patients recover- a pedometer (2D G-sensor) to monitor step count each ing from coronary heart disease. No changes to the day. In line with SDT, research has shown that pedom- cardiac rehabilitation programme were made to accom- eter use leads to: increased ‘autonomy’ (through support- modate cancer patients. Nonetheless, the physiothera- ing tailoring of PA), increased ‘competence’ to achieve pists had attended an additional 1-day educational number of steps (through providing feedback) and ‘re- course delivered by a cancer and exercise specialist (AC) latedness’ (surveillance of participants’ steps can help about PA for people recovering from breast cancer for participants to feel observed and supported) . Some the purposes of the study. Participants could attend participants were given free 3-month leisure centre health education sessions which took place after the ex- membership too, although this was not a planned part of ercise class and included general health advice (e.g. diet, the intervention. exercise, relaxation), alongside cardiac specific sessions (e.g. medications). Participants and recruitment Participants were screened for eligibility at a Leisure centre with 3-month free membership multi-disciplinary team meeting (MDT). At each MDT, This PA programme was designed to be similar to typ- it was agreed by the clinical team which patients were ical ERS . Participants were given a 3-month free eligible for the study and could therefore be approached leisure centre membership at one of the local leisure at an out-patient appointment about the study by a centres in the same city as the hospital where they were breast surgeon or nurse specialist. Reasons for ineligibil- treated for breast cancer, providing them with free ac- ity were recorded at the MDT. Study information was cess to a range of fitness classes, gym and swimming given to eligible patients approximately 2 weeks after pool. During an initial face-to-face induction with a PA surgery at an out-patient appointment by a breast sur- specialist at the leisure centre, the participant received a geon or nurse specialist. A researcher contacted by tele- standard health check by completing the PA Readiness phone participants who indicated willingness to Questionnaire (PAR-Q)  followed by agreement of participate and arranged a face-to-face meeting to Hubbard et al. Pilot and Feasibility Studies (2018) 4:108 Page 5 of 14 Table 1 SDT techniques used during telephone consultations Autonomy: Use (range 0–14) � Offering clear reasons to become more active? 10 (71%) � Giving information to support decisions on different types of activity? 13 (93%) � Give them a choice, and various options for being more active? 13 (93%) � Encouraging enjoyment of PA by choosing activities that participants like doing. 12 (86%) � Avoid coercion and persuasion? Encourage participant to make their own choices? 13 (93%) (e.g. avoid controlling language, rewards, threats, external evaluation, and deadlines). � Using neutral language? 14 (100%) (e.g. ‘may’ and ‘could’, and avoid ‘should’ or ‘must’). � Recognise barriers and conflicting feelings about wanting to be active. 12 (86%) � Encouraging self-monitoring through use of pedometer (and other devices). 13 (93%) � Encouraging setting time aside to include activity, and back up plans if this does not happen. 11 (78%) Competence: � Discuss issues around exercising safely 11 (78%) � Individualised goals for ability, and treatments. 9 (64%) � Providing non-judgemental and positive feedback on progress. 14 (100%) � Focusing on participants’ strengths and celebrate even the small goals. 13 (93%) � Give support on how best to achieve goals. 9 (64%) � Working through pros and cons of being physically active during/after treatment for breast cancer. 8 (57%) � Help with ideas to overcome barriers for those during or after treatment. 6 (43%) � Make sure that not achieving goals does not become a negative. Use it to explore any barriers and/or concerns to help 8 (57%) improve the following week. Relatedness: � Value all opinions discussed. Do not judge progress by being negative or positive. 11 (78%) � Acknowledging participants’ feelings and perspectives. 13 (93%) � Giving positive feedback, such as their performance. Feedback must not make them feel they are being ‘tested’. 14 (100%) � Help participants to indicate their reasons to change their activity levels. 7 (50%) � Showing genuine appreciation and concern for participants by devoting time, energy and resources to support them to be 14 (100%) physically active. discuss the study, confirm willingness to participate and Exclusion criteria obtain written informed consent. Participants were ineligible if any of the above criteria were not met and if the MDT decided that the pa- Inclusion criteria tient lacked capacity to give informed consent or that Female and male patients were eligible if they were aged there were medical or psychological reasons that 16 years or over and were recovering from surgery for would prevent patient adherence to a PA intervention. early-stage (stages I–IIIA) breast cancer or ductal To facilitate MDT decision-making about eligibility, carcinoma in situ (DCIS). Patients were eligible if they the research team delivered a presentation about PA were receiving any adjuvant treatment or had finished contraindications  to the MDT prior to recruit- adjuvant treatment and were living within a 35-mile radius ment. No formal medical assessment was conducted of the PA intervention site. Travel is a known barrier to with the patient because according to international participation in interventions and thelocal NHSpro- experts ‘this would create an unnecessary barrier to vides travel claims for those living in a > 35-mile radius of obtaining the well-established health benefits of exer- the hospital. This inclusion criterion was removed in Phase cise for the majority of survivors, for whom metasta- II because participants could choose telephone-delivered sis and cardiotoxicity are unlikely to occur’(:1412). PA consultations, which removed travel and distance as a Other reasons for exclusion were that the patient was barrier to participation in the study. scheduled to have further surgery in the next 12 weeks Hubbard et al. Pilot and Feasibility Studies (2018) 4:108 Page 6 of 14 and the patient had no access to a landline or mobile different PA programmes. Instead, the following data telephone (Phase II only). were collected from each PA programme: Sample size Cardiac rehabilitation exercise class The number of No formal sample size calculation to power the study was participants receiving the face-to-face induction and par- performed. In Phase I, we used routine hospital data in ticipant attendance at each weekly cardiac rehabilitation the site where the study was conducted about the total exercises class for 12 weeks was objectively measured number of patients having surgery for early-stage breast from routine cardiac rehabilitation service records. cancer to estimate sample size. We estimated that 140 pa- tients over a 6-month period with early-stage breast can- Leisure centre with 3-month free membership The cer would be screened for eligibility and 56 (40%) would number of participants receiving the face-to-face induc- be eligible. Using data from a previous PA study carried tion was recorded from PA specialist records. Leisure out in the same country (i.e. Scotland) with people with centre attendance was objectively measured from early-stage breast cancer , we estimated that 15 (27%) swipe-card membership entry at the leisure centre for eligible patients would consent to the study. In Phase II, the study duration (Phase I = 12 months; Phase II = we used Phase I data to estimate sample size. We esti- 8 months). The proportion of participants taking out mated that 70 patients with breast cancer over a 3-month leisure centre membership at the end of the study was period would be screened for eligibility, 42 (60%) would obtained from leisure centre records. be eligible and 14 (33%) would consent. Telephone-delivered consultations The number of par- Quantitative implementation assessments ticipants receiving the face-to-face induction and the total Table 2 provides an overview of data collected for quanti- number of telephone-delivered PA consultations for each tative PA programme implementation assessments. These participant were self-reported by the PA specialists deliver- assessments drew upon MDT, leisure centre or cardiac ing the consultations. PA specialists self-reported their use rehabilitation routine service databases or upon forms of SDT-based techniques during each telephone-delivered specifically designed for the purposes of the study and PA consultation (Table 1). In addition, participants com- completed by a member of the MDT, leisure centre PA pleted the Perceived Environmental Supportiveness Scale, specialists, cardiac rehabilitation physiotherapists and col- which is a 15-item valid and reliable SDT-informed instru- lated by a researcher. Data were also gathered from partic- ment to measure the extent to which participants perceive ipants by questionnaires and diaries. that their three basic psychological needs (autonomy, com- petenceand relatedness) arebeing met byabehavioural Reach and uptake change intervention . To quantify PA programme reach and uptake, the fol- lowing data were gathered: (1) A researcher collected PA dose screening, eligibility, consent, and drop-out rates; (2) Participants completed a paper diary specifically designed Reasons for an MDT excluding patients using the eli- for the study for 12 weeks during the PA programme. A gibility criteria were recorded at the MDT; (3) Rea- researcher provided guidance on how the diary should be sons for non-participation of eligible patients were completed at the meeting when the participant provided recorded using free text by the breast surgeon or written informed consent. For each day, participants re- nurse specialist at an out-patient appointment when corded the following information about frequency, inten- patients were first approached about the study or by sity, time and type (FITT) parameters: a researcher who telephoned patients if they were in- terested in finding out more about the study before Frequency: Each ‘PA session’ was recorded. A session making up their mind whether to participate; (4) Par- was defined as an occasion when the participant did ticipants’ age and if they were receiving adjuvant any type of PA. Participants were informed that a chemotherapy or radiotherapy at the time they were PA session could include, for instance, a brief walk, referred to a PA programme were retrieved from home-based exercise as well as participation in a MDT records. class at the leisure centre, cardiac rehabilitation and could be of any duration. Engagement and fidelity Intensity: The Borg scale (range 6–20 with 20 being Participant choice of PA programme was recorded. It the hardest) , which is a validated measure of was not possible to integrate standardised assessments intensity, was used to record intensity for each PA of patient engagement or intervention fidelity for the session. Hubbard et al. Pilot and Feasibility Studies (2018) 4:108 Page 7 of 14 Table 2 Implementation assessments Quantitative PA programme Indicator Data source implementation activity assessments Uptake and reach Patient referral % of patients screened for participation MDT records to PA programme % of patients who were eligible % of patients consenting Researcher records % of participants dropping out of the PA programme Reasons for excluding patients Reasons why eligible patients did not wish to participate Mean age of participants % of participants on/off treatment Engagement Providing choice of PA Participant choice of PA programme: Researcher records and fidelity programme, Induction % choosing cardiac rehabilitation Routine cardiac Attendance exercise classes rehabilitation service SDT-based motivational % choosing local leisure centre with 3-month records interviewing, free membership PA specialist records Behaviour Change Techniques % choosing telephone-based Leisure centre records (e.g. goal-setting, PA consultations Participant questionnaire monitoring) Cardiac rehabilitation: (Perceived Environmental Number of participants Supportiveness Scale) receiving induction Number of exercise classes attended by participants Leisure Centre with 3-month free membership: Number of participants receiving induction Number of visits to leisure centre over study duration % of participants taking out leisure centre membership at end of the study Telephone-delivered PA consultations: Number of participants receiving induction Number of consultations delivered % of SDT-based techniques used Mean score psychological needs met by PA programme PA dose Frequency Participant PA diaries Total number of PA sessions (defined as an occasion when the participant did any type of PA) Intensity Mean intensity of PA sessions Time Mean minutes per week spent of PA sessions Type % of PA sessions categorised by type, e.g. walking, jogging, cycling, etc. Other: Mean daily step count Time: Duration in minutes for each PA session was or flexibility exercises (which could be conducted either recorded. at home or in a leisure centre); swimming or Type: Type of PA for each PA session was recorded. housework. During analysis, type of PA was categorised by a researcher using the following eight categories: walking; In Phase II, participants were also given a pedometer so jogging/running; cycling; other cardiovascular (e.g. that they could monitor daily pedometer (2D G-sensor) spinning, running machine, aerobic classes), resistance recorded steps over the 12-week PA programme. Hubbard et al. Pilot and Feasibility Studies (2018) 4:108 Page 8 of 14 Qualitative study component: participant views of the PA programme and (2) barriers and facilitators for engaging programme in PA. Second, subthemes were identified for each of these two main themes and a narrative summary of Sampling In Phases I and II, all participants were in- coded data was made under each subtheme. Finally, the vited for interview with a researcher at the end of the researcher referred to the original data to ensure that 12-week PA programme. participant accounts were accurately presented in this paper. Quotations to illustrate themes are available in Procedures All participants were contacted by tele- Additional file 2. The observed effect of the PA pro- phone to arrange an interview. A face-to-face or tele- grammes is reported descriptively using mean and SD phone digitally recorded interview (depending on pre- and post-intervention for the following variables: participant preference) approximately 2 weeks after the PA, self-efficacy for PA, quality of life, fatigue, and fear PA programme in Phases I and II was arranged. Partici- of recurrence. pants could choose whether to have the face-to-face interview take place in their own home or at the univer- Results sity. Informed consent interview participation was ob- Reach and uptake tained when they first provided written informed Participant flow throughout the study is available in consent at the beginning of the study. Verbal consent Additional file 3. The screening rate in Phases I and II was obtained from each individual before the interview was > 90% (Phase I n = 158 (100%); Phase II n =68 and actual recording took place. All interviews were on (94%)); the eligibility rate was 42% (n = 67) and 54% (n = a one-to-one basis with the researcher. 37), respectively; the consent rate was approximately 30% (Phase I n = 20 (30%); Phase II n = 21 (32%)) and Schedule A semi-structured interview schedule was the drop-out rate was 5% (n = 1) and 8% (n = 1), used because it allows flexibility in what sequence ques- respectively. In Phase I, 63% (n = 57) were ineligible be- tions are asked, and how particular issues might be cause they lived > 35-mile radius of the hospital and 17% followed up and developed with different interviewees. (n = 8) of eligible patients did not wish to participate be- The schedule was developed to cover factors influencing cause of distance. Hence, in Phase II, we removed travel participants’ choice of PA programme, factors that facili- and distance as barriers to participating in a PA tated and impeded engagement in the PA programme programme by giving patients choice of receiving and experiences of the programme. Hence, the schedule telephone-delivered PA consultations or attending the was developed to reflect the research aims but was not leisure centre. In Phase II, 45% of screened patients were too prescriptive so that the researcher could probe issues deemed ineligible to participate in a PA programme for that emerged during the interview. health reasons (e.g. poor wound healing) by the MDT. Seventeen percent and 32% of eligible patients in Phases Analysis I and II, respectively, were not interested in participating Quantitative data about PA programme implementation in the study. were analysed descriptively. Descriptive statistics were In both phases, the average age of consenting patients calculated for reach and uptake (e.g. screening, eligibil- was 57 years (Phase I: range 38–77 years; Phase II: ity, consent and drop-out, reasons for ineligibility and (range 43–77)). In Phases I and II, 70 and 91%, respect- declining participation, age and on/off treatment), en- ively, of participants were receiving adjuvant therapy gagement and fidelity (e.g. PA programme choice, PA when they started the PA programme. In Phase I, seven programme attendance/consultations, SDT-based tech- of the 20 participants were receiving chemotherapy niques), PA dose (frequency, intensity, time and type) when they started the PA programme and seven were and reported as n (%) for categorical data and mean receiving radiotherapy (with two of these having (Standard deviation [SD]) for continuous data. Qualita- completed neo-adjuvant chemotherapy). In Phase II, two tive data about the PA programmes were analysed the- of the 12 participants were receiving chemotherapy (with matically. Audio-recorded qualitative interviews were radiotherapy to follow) and nine were receiving radio- transcribed verbatim and analysed thematically using the therapy (one having completed neo-adjuvant Framework approach , which is a rigorous method chemotherapy). providing a structure within which qualitative data are organised and coded and themes are identified. In brief, Engagement and fidelity a researcher (GH) became familiar with the interview In Phase I, 17 (85%) participants chose referral to the leis- transcript data by reading and rereading transcripts and ure centre with 3-month free membership, and three (15%) assigning interview data (sentences and paragraphs) to chose cardiac rehabilitation exercise classes. In Phase II, two main themes, which were (1) choice of PA three (25%) participants chose the leisure centre with Hubbard et al. Pilot and Feasibility Studies (2018) 4:108 Page 9 of 14 3-month free membership and nine (75%) chose telephone-based PA consultations had the face-to-face in- telephone-delivered PA consultations. In Phase I, all three duction. The average number of participant contacts with participants choosing cardiac rehabilitation exercise classes a PA specialist (including messages left on the telephone) received the face-to-face induction. One participant over the 12-week programme was six. All nine partici- attended all 12 weekly classes, one attended 11 out of 12 pants who chose weekly telephone-based PA consultations classes and one did not attend any classes. In Phase I, all 17 had ≤ 4 telephone PA consultations. participants choosing the leisure centre with 3-month free Out of the 23 telephone-delivered PA consultations, 14 membership received the face-to-face induction. According (61%) SDT-based technique self-report questionnaires were to leisure centre membership records, 11 out of 17 Phase I completed by a PA specialist. Table 1 shows if the participants had leisure centre membership. Minimum and SDT-basedtechnique was reportedtohavebeenuseddur- maximum leisure centre attendance of the 11 participants ing the telephone-delivered consultation. PA specialists re- with leisure centre membership between 1 July 2015 and 1 ported that they used SDT-based techniques to foster July 2016 (i.e. during the 12 month study) was 0 and 65 ‘autonomy’ in over 78% of the telephone-based consulta- times. In Phase II, nine out of 12 participants, had leisure tions delivered. Techniques to foster ‘competence’ were not centre membership (some who chose telephone-based PA used to the same extent. For example, discussing individua- consultations had leisure centre membership). Four lised goals was used in 64% of the telephone-delivered con- participants already had leisure membership prior to ad- sultations. Most techniques to foster ‘relatedness’ were mission to the study. Provision of free leisure centre mem- used in most telephone-delivered consultations (78–100%). bership was expected to be given to those who chose the Scores from seven participants were included in analysis leisure centre but it was not part of the telephone-based of the Perceived Environmental Supportiveness Scale. The PA consultation programme. Nonetheless, five participants, mean score was 90.71 (SD 13.4) (min 71 max 105). including two who chose the telephone-based PA consult- ation programme, were given 3-month free leisure centre Physical activity dose membership during Phase II by the PA specialists. Mini- The PA dose delivered was assessed using FITT parame- mum and maximum leisure centre attendance of the nine ters calculated from participant diaries (Table 4). Eight participants with leisure centre membership between 1 Au- out of 20 (40%) and nine out of 12 (75%) participants in gust 2016 and 30 April 2017 (i.e. 8 months) was 0 and 14 Phases I and II, respectively, provided FITT data (i.e. times. None of the five participants who were provided completed a diary). Walking was the most common type with a free 3-month leisure centre membership took out of PA (57.8 and 72% in Phases I and II, respectively). paid membership immediately after the study. Self-reported intensity was similar in Phases I and II. For In Phase II, two out of the three participants who chose all participants, mean intensity was 11.48, which is to- the leisure centre with 3-month free membership had the wards the high end of ‘light’ intensity of the Borg scale face-to-face induction (data missing for one participant) (range 6–20 with 20 being the hardest) . Mean time (Table 3). Four out of the nine participants who chose the in minutes for a PA session was 55.70 and 76.59 in Table 3 Phase II face-to-face and telephone consultations or email correspondence Participant ID Face-to-face Telephone Answerphone message Email Total number of contacts (including messages) Participants choosing face-to-face PA consultations 101 4 0 2 0 6 107 4 1 0 3 8 Participants choosing telephone PA consultations 109 0 1 1 0 2 110 1 0 2 1 3 105 0 3 1 2 6 103 0 3 0 2 5 102 2 4 0 0 6 108 1 4 0 1 6 106 0 4 0 2 6 111 0 2 2 1 5 112 3 1 0 0 4 Total 15 23 8 12 57 Data missing for one participant Hubbard et al. Pilot and Feasibility Studies (2018) 4:108 Page 10 of 14 Table 4 FITT parameters Phase I (n = 8) Phase II (n =9) N (PA sessions) % N (PA sessions) % Total number of PA sessions reported by participants 313 – 710 – Type % of n Walking 57.8% 72% Jogging/running 6.4% 0.3% Cycling 1.9% 0% Other cardiovascular 44.4% 16.8% Resistance 17.3% 6.1% Flexibility 2.2% 3.4% Swimming 0% 0.8% Housework 2.6% 17% Mean(SD) Mean(SD) Intensity reported by participants for each PA session 286 11.97 (SD 2.54) 580 11.24 (SD 2.33) (range 6–20 with 11 representing fairly light intensity requiring little or no effort) Time (min) per day reported by participants 310 55.70 (SD 54.07) 576 76.59 (SD 78.18) for each PA session N (participants) Steps –– 9 75% Average step count per day 7584.56 (SD 3805.62) E.g. spinning, running machine, aerobic classes Phases I and II, respectively. Only Phase II participants not wish to engage in PA among the general public and were given a pedometer to record step count; mean step therefore chose cardiac rehabilitation exercise classes count per day was 7584.56 (SD 3805.62). (exercising with other people who were recovering from illness) or telephone-delivered PA consultations in Phase Participant opinions about the intervention II. However, some participants chose the leisure centre Nine out of 20 in Phase I and 10 out of 12 participants with 3-month free membership in order to socialise. in Phase II were interviewed. One interview was con- One participant, for instance, chose the leisure centre ducted by telephone, and the others were conducted with 3-month free membership because she believed face-to-face at the university. that it would help build her confidence to meet other people. Since her breast cancer diagnosis, she had Choice of PA programme spent most of the time meeting other people recover- Four themes were identified from qualitative interviews ing from cancer and the leisure centre provided an op- about PA programme choice: travel distance, socialising, portunity to meet people who did not have cancer. relevance and flexibility. In Phase II, the main reason for One participant questioned the relevance of cardiac choosing telephone-delivered PA consultations rather rehabilitation exercise classes for people with breast than the leisure centre was long travel distance from the cancer since the programme was designed for people leisure centre. Nonetheless, travel distance created diffi- recovering from a cardiac event and chose the leisure culties for participants choosing telephone-delivered PA centre with 3-month free membership. Some partici- consultations because they still needed to arrange a pants chose the leisure centre with 3-month free face-to-face PA induction with an exercise specialist at the membership because it provided greater flexibility for leisure centre prior to commencing telephone-delivered being physically active. The leisure centre enabled support. One participant felt that travelling such a long people to engage in activity that was not weather distance just for a brief PA induction seemed hardly worth dependent. Cardiac rehabilitation exercise classes were it. One participant who chose leisure centre with 3-month offered once a week, on a set day and time, which did free membership found travelling frustrating and impeded not suit everyone. Concerns about missing sessions regular attendance. due to feeling unwell, for instance, were eased when it Some participants felt self-conscious about their ap- was explained that they could attend the leisure centre pearance following mastectomy. These participants did at atimethat suitedthem. Hubbard et al. Pilot and Feasibility Studies (2018) 4:108 Page 11 of 14 Facilitators and barriers for engaging in PA , 66% , 61% . Whythestudyhas arela- Four themes were identified from the qualitative in- tively low consent rate is unclear. The reasons given terviews about facilitators and barriers for engaging in by eligible patients for refusing to participate in the PA: feeling better, feeling ill, weight management, study are similar to other studies and include health family and friends. Participants perceived that PA issues, not being interested, and other commitments made them feel better. One participant said that she (e.g. family and work) [45, 47, 49]. These factors are also had felt powerless and helpless during her treatment cited in the literature as barriers to being physically active for breast cancer and that engaging in PA gave her following a breast cancer diagnosis [27, 50–53]. Address- back a sense of control. Another participant said that ing these factors in future studies can therefore serve the when she was active it stopped her from worrying dual purpose of increasing PA as well as the appeal of par- about ‘what might be’ (i.e. fear of recurrence). None- ticipating in studies of community-based PA programmes. theless, a barrier to participation in the PA The eligibility rate (46%) is comparatively low com- programme was feeling ill as a consequence of receiv- pared to some previous trials of community-based PA ing adjuvant therapy. Some participants experienced interventions: 76.9% , 61% , 46% , 79% . fatigue or felt sick and dizzy which they said pre- One seemingly obvious reason for this variation between vented them from partaking in PA. Several partici- studies is use of different eligibility criteria. Yet, two tri- pants explained that they had put on weight due to als with similar eligibility criteria (e.g. people with breast treatments and wished to be active to help them to cancer must have completed treatment, are physically lose and maintain weight loss. Family and friends inactive and have no contraindications for exercise) had were key sources of support for engaging in PA. They differing eligibility rates of 42%  and 79% , re- accompanied participants during an activity such as spectively. Another possible explanation for variation in walking. Having a pet dog also constituted a source eligibility rates is a difference in clinician interpretation of support because the dog needed to be walked. and application of eligibility criteria. In the study, the Family and friends acted as competition for daily step MDT excluded 45% of patients in Phase II but only 9% counts and were therefore an important source of in Phase I, which could be an artefact of differences in motivation. Participants could become friends and recruitment time periods (3 versus 6 months) or clin- help each other. A couple of participants who chose ician variation in application of eligibility criteria. The PA telephone-delivered consultations, for instance, proportion of people excluded by clinicians will influ- teamed up to attend the gym together and found this ence PA programme reach and convincing clinicians of was beneficial because they could talk about the exer- the benefits of PA for people with cancer may go some cises and how they were feeling on the day. Neverthe- way towards improving the recruitment rate . less, family commitments can also act as a barrier to participation. One participant explained that attending Engagement to thefamilymembers’ needsmeant she wasunable The qualitative interviews give insight about patient PA to go to the gym during a particular week. programme choice, with some participants choosing telephone-delivered PA consultations because they did not wish to travel long distances to attend the leisure Discussion centre and others choosing telephone-delivered consul- The aim of this paper was to address the general lack of tations because they felt self-conscious about their ap- published data about how practitioners deliver a PA pearance following mastectomy and therefore did not intervention and the extent to which participants engage wish to engage in PA in front of members of the public. in the PA programme . This exploratory study raises Preference for home-based PA was found in a previous the following issues relating to implementation of survey of rural people with breast cancer (n = 483), with community-based PA programmes for people recovering respondents indicating a preference for home-based from surgery for breast cancer: (63%), unsupervised (47%) and moderate intensity exer- cise (65%) that was primarily walking . Reach and uptake The PA intervention was designed to allow maximum The study had very high retention rates with only two participant choice for the type of PA that they did during participants dropping out of the study due to ill-health. the 12-week PA programme. Diaries completed by par- The retention rate is therefore somewhat consistent ticipants show that the most common type of PA was with previous trials of community-based PA interven- walking (57.8%) and intensity was ‘fairly light’ (mean = tions ≥ 80% [28, 45–48]. Nonetheless, the study con- 11.97; SD 2.54). A survey of people with breast cancer sent rate (31%) is relatively low compared to other (n = 160) during chemotherapy found that walking and community-based PA interventions: 71% , 61% exercises specific to women with breast cancer were Hubbard et al. Pilot and Feasibility Studies (2018) 4:108 Page 12 of 14 most frequently performed and preferred ; another Nonetheless, a strength of the study is that it took survey of patients (n =23)  during treatment found place in a ‘real-world’ setting because it is delivered by that the majority preferred walking (100%) at PA specialists at a local leisure centre and therefore moderate-intensity (61%) and another study (n = 12) likely to reflect what would happen were the PA inter- found that walking was the most acceptable exercise vention implemented into the cancer care pathway. In modality . Preferences for walking have also been the study, over half of the Phase II participants did not found in a survey of cancer survivors with different diag- receive a face-to-face induction with a PA specialist noses . A challenge therefore is encouraging people whereas in a previous trial all face-to-face induction to engage in their preferred activities, such as walking, at prior to telephone-delivered support were carried out a level of intensity that will optimise health benefits and . A key difference between these two studies was to progress mean rates of excursion during a 12-week who was delivering the intervention. In this study, the programme. Addressing this challenge may be critical PA induction and telephone-delivered consultations because the findings of observational studies of PA and were delivered by PA specialists at a community-based breast-cancer specific and all-cause mortality that have leisure centre who were expected to fit the delivery of been summarised in meta-analyses and systematic reviews the PA programme around their other daily tasks suggest that there may be a dose-response [4, 59], and whereas in the other study the PA counsellor was a Mas- while there is limited evidence about a dose-response rela- ter’s degree trained research assistant specifically tionship for other health benefits, one meta-analysis re- employed to deliver the PA programme. This key differ- vealed that there may be a dose-response relationship for ence may explain variation in intervention fidelity be- fatigue . tween the two studies. A challenge for using existing community-based services rather the research team de- Fidelity livering the PA intervention is therefore a lack of direct All Phase I participants received an induction by a management over the weekly activities of the individuals cardiac rehabilitation physiotherapist or PA specialist who are delivering the intervention. from the leisure centre but only 50% of Phase II partici- pants received an induction by a PA specialist from the Strengths and limitations leisure centre. In Phase II, use of each of the 22 The strengths of this feasibility work relate to the re- SDT-techniques reported by the PA specialists during a cruitment of a sample generally representative of the telephone-delivered consultation was high, with only breast cancer population and the evaluation of a PA two techniques being used in half or less of the PA con- intervention, which was delivered using a pragmatic ap- sultations delivered by telephone. In Phase II, partici- proach suitable for translation into practice. Limitations pants perceived that their three basic psychological include the study only being conducted in one site with needs (autonomy, competence and relatedness) were a small sample which limits generalisability. met by the PA specialists. However, self-reported use of behaviour change techniques is limited because of biased Conclusion reporting and objective measurement such as recording The current community-based PA intervention is not PA consultations should be considered in future trials. yet suitable for progression to a definitive effectiveness In the study, the average number of participant contacts randomised controlled trial. Further work is needed to (e.g. face-to-face, telephone, email) by a PA specialist optimise PA programme reach, uptake and fidelity. Further over the 12-week PA programme was six. While this is work is also required to assist participants to progress their half than what was planned, this actual number is simi- level of exercise intensity when engaging in their preferred lar or greater than other telephone-delivered PA trials of activity, for example, walking so that they achieve the health similar duration [45, 48]. In a previous trial, the mean benefits associated with moderate to vigorous PA. number of calls was 6.7 (SD 1.81) , and in another study, the average total contact time over a 12-week Additional files home-based walking programme was 90 min . Al- though the optimal contact time to promote behaviour Additional file 1: Figure S1. Logic model for referral to PA programmes. (DOCX 91 kb) change is uncertain, the qualitative interviews suggest Additional file 2: Quotations. (DOCX 111 kb) that some participants found weekly ‘checking up’ by a Additional file 3: Flow chart. (DOCX 117 kb) PA specialist on their amount of PA a source of motiv- ation. For these participants at least, weekly contact Abbreviations (face-to-face, telephone or email) over the course of a MDT: Multi-disciplinary team; PA: Physical activity; PAR-Q: Physical Activity PA programme is likely to be important for the improve- Readiness Questionnaire; SDT: Self-determination theory; UK: United ment of PA and health. Kingdom Hubbard et al. Pilot and Feasibility Studies (2018) 4:108 Page 13 of 14 Acknowledgements systematic review of quantitative studies. J Cancer Surviv. 2013;7(3): We thank all patients who participated in the study, members of the breast 300–22. cancer care team who recruited patients to the study, exercise specialists 8. Campbell A, Stevinson C, Crank H. The BASES expert statement on who delivered the intervention and Iga Janiszewska (student nurse) for exercise and cancer survivorship. J Sports Sci. 2012;30(9):949–52. assisting in data analysis. 9. 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Role of physical activity and sport in Authors’ contributions oncology: scientific commission of the National Federation Sport and GH, JG, AF, MH, GO, RM, EB and AC designed the study. GH and JM collected Cancer CAMI. Crit Rev Oncol Hematol. 2015;94(1):74–86. the data. GH, JM and TG analysed the data. WM and AC delivered training 12. Rock CL, Doyle C, Demark-Wahnefried W, Meyerhardt J, Courneya KS, for the intervention. All authors read and approved the final manuscript. Schwartz AL, Bandera EV, Hamilton KK, Grant B, McCullough M, et al. Nutrition and physical activity guidelines for cancer survivors. CA Cancer J Ethics approval and consent to participate Clin. 2012;62(4):243–74. North of Scotland Research Ethics Committee, REC reference: 15/NS/0036. 13. Boyle T, Vallance JK, Ransom EK, Lynch BM. How sedentary and physically active are breast cancer survivors, and which population Competing interests subgroups have higher or lower levels of these behaviors? 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Pilot and Feasibility Studies – Springer Journals
Published: Jun 1, 2018