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Background The addition of qualitative methodology to randomised controlled trials evaluating complex interventions allows better understanding of contextualised factors and their potential influence on trial delivery and outcomes, as well as opportunities for feedback on trial participation to improve future trial protocols. This study explored the experiences of participation in cancer rehabilitation research during active cancer treatment. Participants were people living with haematological cancer myeloma, undergoing autologous stem cell transplantation (ASCT) recruited to the PERCEPT myeloma pilot trial. Methods A qualitative semi-structured interview study, embedded within a pilot randomised controlled trial of a physiotherapist-led exercise intervention delivered before, during and after ASCT among people living with myeloma. Transcripts were analysed using reflexive thematic analysis. Results Interviews from 16 trial participants (n = 8 intervention group; n = 8 control group; mean age 61 years, 56% male) were analysed. Four main themes were identified: (1) “It’s not just beneficial for me, it’s for people after me as well”; (2) Disparities in experience of recovery – expectations, feeling prepared and support; (3) “What I wanted to do was build myself back up and prepare”; (4) Active ingredients – participants’ experience of the trial intervention. Participants reported both altruistic and perceived personal gain as motivators for enrolling in the trial. Disappointment caused by allocation to control arm may have led to participants seeking exercise elsewhere, indicating possible contamination of control condition. Disparities in experience of recovery from transplant were evident with intervention participants reporting greater trajectory of recovery. Conclusions The findings from this embedded qualitative study highlight numerous considerations required when designing pilot and efficacy trials of complex interventions. The addition of qualitative investigation offers greater understanding of motivations for participation, intervention mechanisms at play as well as effects of participation that may impact interpretation of quantitative outcomes. Trial registration Qualitative findings from a prospectively registered pilot trial (ISRCTN15875290), registered 13/02/2019.

Purpose The Myeloma: Advancing Survival Cancer Outcomes Trial (MASCOT) tested the impact of a supervised exercise programme on fatigue, clinical, and patient-reported outcomes in multiple myeloma [MM] patients. The current study explored MM patients’ experiences of the programme to guide future interventions. Methods Purposive sampling was used to recruit stable MM patients participating in MASCOT. Semi-structured, face-to-face interviews were conducted, transcribed verbatim, and analysed using thematic analysis. Results Six themes were identified. Key drivers for participation in MASCOT were “Altruism and extended cancer care”; participants wanted to give something back and assist in improving post-treatment care for MM patients, especially as after treatment “Barriers to being physically active” were a fear of damage and lack of health professional guidance. “Influences fostering change within the intervention” included physiotherapy supervision and tailored exercises, which gave participants confidence to push themselves in a safe environment and broke down misconceptions about their body. “Social support”, from both family and peers in the programme, promoted motivation and adherence. Participants expressed concerns about “Maintaining things going forward” but had identified mechanisms to aid continuation. “Physical and mental benefits” of the programme were highlighted; participants were able to do things they couldn’t before and described feeling free from the constraints of MM. Conclusions A post-treatment exercise intervention for MM patients was a positive experience, which enhanced participants’ physical and psychological wellbeing. Tailored gym and home-based exercises, a specialist cancer physiotherapist, and sustained support were perceived to be important for success. Implications for cancer survivors Exercise support for MM patients, ideally with physiotherapist supervision, should be incorporated into survivorship care to qualitatively improve patients’ quality of life, self-efficacy, and mental wellbeing.

Purpose Patients with multiple myeloma suffer from disease-related complications such as bone destruction, toxicities from repeated therapies and age-related co-morbidities. With improved treatment options, patients are living longer and have specific survivorship needs such as low exercise levels that need to be addressed. In this study, we designed, implemented and evaluated a multidisciplinary team (MDT) myeloma clinic that provided participants with tailored exercise and lifestyle advice. Methods The Promoting Individualised Self-Management and Survivorship (PrISMS) clinic was set up in two UK myeloma centres. This remote MDT clinic comprised of a doctor, a nurse specialist and a physiotherapist. Patients were required to complete blood tests and a questionnaire about their symptoms and concerns before each consultation. Patient-reported outcome measures were captured using validated questionnaires. Patient feedback was collected using a specially designed survey and structured telephone interviews. Results Sixty-one patients were enrolled in the pilot clinic with 210 consultations held during the study period. Nine patients had disease progression and were referred safely back to face-to-face clinics. There was a significant improvement in patients’ exercise score (p = 0.02) after PrISMS clinic. Patient satisfaction was high, with 83% feeling more confident in self-managing myeloma after PrISMS clinic. Conclusion PrISMS clinic is safe and feasible, with high patient compliant and acceptability. It empowers patients to self-manage their condition and encourages physical activity, which is associated with improved quality of life and fatigue level. Future randomised controlled trials will help to confirm its benefits on patient clinical outcomes and cost-effectiveness.

Autologous stem cell transplant (ASCT) is first line treatment for newly diagnosed patients with myeloma but often results in functional deficits and reduced quality of life (QOL). Physically active myeloma patients have better QOL, less fatigue and reduced morbidity. This trial aimed to investigate the feasibility of a physiotherapist-led exercise intervention delivered across the continuum of the myeloma ASCT pathway at a UK centre. Initially designed and delivered as a face-to-face trial, the study protocol was adapted to virtual delivery in response to the COVID-19 pandemic. A pilot randomised controlled trial of a partly supervised exercise intervention with incorporated behaviour change techniques delivered before, during and for 3 months following ASCT compared to usual care. Face-to-face delivery of the pre-ASCT supervised intervention was adapted to virtually-supervised group classes via video conferencing. Primary outcomes related to feasibility; recruitment rate, attrition and adherence. Secondary outcomes included patient reported measures of QOL (EORTC C30, FACT-BMT, EQ5D), and fatigue (FACIT-F), measures of functional capacity (six-minute walk test (6MWT), timed sit-to-stand (TSTS), hand grip strength, self-reported and objective physical activity (PA). Over 11 months 50 participants were enrolled and randomised. Overall, uptake to the study was 46%. The attrition rate was 34%, mainly related to failure to undergo ASCT. Loss of follow-up for other reasons was low. Secondary outcomes demonstrate potential for the benefit of exercise prior to, during and after ASCT with improvements in QOL, fatigue, functional capacity and PA evident on admission for ASCT and 3 months post-ASCT. Results indicate acceptability and feasibility of delivering exercise prehabilitation, in person and virtually within the ASCT pathway in myeloma. The effects of prehabilitation and rehabilitation provision as a component of the ASCT pathway warrants further investigation.

Introduction and objectiveResearch activity was impacted by the novel COVID-19 pandemic, the PERCEPT myeloma trial was no exception. This pilot randomised trial delivered a face-to-face exercise intervention prior to and during autologous stem cell transplantation (ASCT) in myeloma patients, as a consequence of COVID-19 it required significant adaptions to continue. This brief communication describes how the previously published study protocol was adapted for virtual delivery. In addition, we highlight the challenge of continuing the study which was embedded within a clinical pathway also impacted by the pandemic.SummaryThe original trial protocol was amended and continued to recruit and deliver an exercise prehabilitation intervention virtually. Continued delivery of the intervention was deemed important to participants already enrolled within the trial and the adapted virtual version of the trial was acceptable to the research ethics committee as well as participants. Development of effective, remotely delivered rehabilitation and physical activity programmes are likely to benefit people living with myeloma. The COVID-19 pandemic provided an opportunity to explore the feasibility of a virtual programme for ASCT recipients, however, continued changes to the clinical pathway within which the study was embedded posed the greatest challenge and ultimately led to early termination of recruitment.Trial registration numberISRCTN15875290; pre-results

Background Exercise may improve fatigue in multiple myeloma survivors, but trial evidence is limited, and exercise may be perceived as risky in this older patient group with osteolytic bone destruction. Methods In this Phase 2 Zelen trial, multiple myeloma survivors who had completed treatment at least 6 weeks ago, or were on maintenance only, were enrolled in a cohort study and randomly assigned to usual care or a 6-month exercise programme of tailored aerobic and resistance training. Outcome assessors and usual care participants were masked. The primary outcome was the FACIT-F fatigue score with higher scores denoting less fatigue. Results During 2014–2016, 131 participants were randomised 3:1 to intervention (n = 89) or usual care (n = 42) to allow for patients declining allocation to the exercise arm. There was no difference between groups in fatigue at 3 months (between-group mean difference: 1.6 [95% CI: −1.1–4.3]) or 6 months (0.3 [95% CI: −2.6–3.1]). Muscle strength improved at 3 months (8.4 kg [95% CI: 0.5–16.3]) and 6 months (10.8 kg [95% CI: 1.2–20.5]). Using per-protocol analysis, cardiovascular fitness improved at 3 months (+1.2 ml/kg/min [95% CI: 0.3–3.7]). In participants with clinical fatigue (n = 17), there was a trend towards less fatigue with exercise over 6 months (6.3 [95% CI: −0.6–13.3]). There were no serious adverse events. Conclusions Exercise appeared safe and improved muscle strength and cardiovascular fitness, but benefits in fatigue appeared limited to participants with clinical fatigue at baseline. Future studies should focus on patients with clinical fatigue. Clinical trial registration The study was registered with ISRCTN (38480455) and is completed.

Objective: We utilised a method rarely seen in cancer behavioural trials to explore methods of overcoming difficulties often seen in randomised controlled trials. We report our experiences of the adapted-Zelen design, so that other researchers can consider this approach for behavioural trials. Study Design& Setting: The adapted-Zelen design was used to explore the effects of exercise on multiple myeloma patients fatigue, quality of life and physical outcomes. All participants consented to an observational cohort study of lifestyle factors, but were unaware of subsequent randomisation to remain in cohort only group or be offered an exercise intervention requiring second consent. Results: Due to lower than expected uptake rate to the exercise offered group (57%), the length of recruitment increased from 24 to 29 months to ensure power was reached. At enrolment patients were unaware of the potential increased commitment and as a result 62% of participants allocated to the intervention declined due to the extra time/travel commitment required. This emulates clinical settings and suggests improvements in intervention delivery are required. Dropout rates from the cohort only group were similar to designs that provide the control with the intervention. Our results from the main study do not suggest contamination occurred despite some anecdotal evidence. Conclusion: Future use of this design warrants careful consideration of the study resources and recruitment time frames required but holds potential value in reducing contamination, control group dissatisfaction and resulting drop out. Adapted-Zelen design reduces selection bias and therefore gives clinicians a better understanding of acceptability in clinical settings. Future studies should evaluate control group experiences of the design and formally record contamination throughout the study to confirm its acceptability.

Objective Physical activity has been shown to improve quality of life in cancer patients with some evidence in multiple myeloma. This study aimed to determine myeloma patients’ exercise levels, their perception of physical activity, and to explore correlations with quality of life. Myeloma outpatients were invited to complete a number of questionnaires, including the Godin leisure-time exercise questionnaire (GLTEQ) to determine their exercise levels, the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire to assess health related quality of life, and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire to assess fatigue. Results Of the 65 respondents, 75% would like to increase their exercise level. Weakness, fatigue and pain were the most commonly perceived barriers to physical activity. 59% would like to receive physical activity advice. Only 25% were deemed active based on their GLTEQ scores. Finally, there was a significant positive correlation between the GLTEQ score and the FACT-G score (p

IntroductionMyeloma, a blood cancer originating from plasma cells, is the most common indication for autologous stem cell transplantation (SCT). Patients with myeloma undergoing autologous SCT (ASCT) experience treatment-related morbidity and reduction in function and well-being for many months post-treatment. Interventions targeting physical functioning delivered prior to and during SCT have shown promising results in mixed haematological populations and may offer a non-pharmacological solution to physically optimising and preparing patients for SCT. The aim of this study is to investigate the feasibility of a physiotherapist-led exercise intervention as an integral part of the myeloma ASCT pathway at a UK tertiary centre.Methods and analysisPERCEPT is a single-site, pilot randomised controlled trial of an exercise intervention embedded within the myeloma ASCT pathway, compared with usual care. The primary study end points will be feasibility measures of study and intervention delivery including recruitment rates, acceptability of intervention, study completion rate and any adverse events. Secondary end points will evaluate differences between the exercise intervention group and the usual care control group in cancer-related fatigue, quality of life, functional capacity (6 min walk test; handheld dynamometry; a timed sit-to-stand test) and objective and self-reported physical activity. Outcomes will be assessed at four time points, approximately 6–8 weeks prior to SCT, on/around day of SCT, on discharge from SCT hospital admission and 12 weeks post-discharge. The exercise intervention comprises of partly supervised physiotherapist-led aerobic and resistance exercise including behaviour change techniques to promote change in exercise behaviour. The primary outcomes from the trial will be summarised as percentages or mean values with 95% CIs. Group differences for secondary outcomes at each time point will be analysed using appropriate statistical models.Ethics and disseminationThis study has NHS REC approval (Camden and Kings Cross, 19/LO/0204). Results will be disseminated through publication and presentations at haematology and rehabilitation-related meetings.Trial registration numberISRCTN15875290.

Background: Qualitative research (QR) has permeated into the areas of ‘hard science’, including medicine. Still, there remains criticism about the suitability of QR for the medical context. In contrast, the QR experts argue that high level of skill in conducting qualitative interviews and analysis is required as the lack of such may lead to poor data collection or invalid conclusions. Despite these reservations clinicians (UCLH) and academics (UCL) designed a qualitative study which will inform the decision-making process related to the set-up of a telephone clinic for patients with myeloma through an exploration of the benefits and barriers to using such service. This presentation is a reflection on the collaboration between academics and clinicians. Learnings: Qualitative interviewing differs from the instructive style of communication doctors use, but the collaborating clinicians were open to learn it and felt that it allowed them to become less paternalistic, and turn towards a holistic approach to negotiating health services with patients. The use of QR was viewed as an opportunity for a doctor-patient dialog about the development of a service that is safe and acceptable both to patients and clinicians, time-efficient and empowering patients to manage their illness. Conclusion: QR provided added value to the work of medical professionals and was used to identify patients9 needs in the context of a proposed healthcare system. The interviews created an opportunity to ensure that patients9 opinions were heard and used to inform the development of a service in a way that is acceptable to the patients.

Background. With increasingly effective treatments, patients with Multiple Myeloma ('MM') are living longer, but burden of disease and cumulative toxicities of therapy impair quality of life ('QoL') and well-being. Fatigue and bone pain frequently persist long after treatment, and during disease stability. Research in solid cancers indicates that patients who are more physically active have reduced symptom burden, less fatigue and improved QoL. Less work has been done in MM, partly due to the older and frailer patient group, and the high prevalence of osteolytic bone disease and fracture risk. The MASCOT survivorship study aims to explore the main determinants of fatigue and QoL in patients who have completed chemotherapy, with particular emphasis on bone pain, physical fitness and strength. Methods. Multivariable linear regressions were performed between: 1) fatigue and measures of physical health and fitness and 2) each of 6 measures of QoL as outcome variables (fatigue, emotional well-being, functional well-being, global well-being, EQ5D QoL, and overall health status) with each of pain, depression and anxiety; all adjusted for age, sex, time since treatment, Hb, fat body %, fat trunk %, BMI, VO2peak, left grip strength, right grip strength, left leg muscle strength, right leg muscle strength, and muscle mass. Results are shown as regression coefficients B (change in fatigue score for 1 unit increase in physical health or fitness; or a change in QoL for 1 unit increase in pain, depression or anxiety). 80 patients aged 36-78 years (male, n=46), were studied at median 13.5 months (range 2-161) since last treatment. Physical health and cardiovascular fitness were assessed using objective measures: % body and trunk adiposity, muscle mass, body mass index (TANITA scales), VO2peak (CPET on a cycle ergometer), leg muscle strength and grip strength. The presence of bone pain was self-reported and evaluated in a clinical consultation. Standardised questionnaires were used to assess mood (HADS), fatigue (FACIT), functional and emotional well-being (FACT-G) and health related QoL (EQ5D). Higher scores on FACT-G and FACIT, health status scales and lower scores on HADS and EQ5D indicated better quality of life. Results. We investigated the influence of physical fitness on levels of fatigue, using multivariable regression. We found that higher levels of fatigue were associated with higher BMI (B = -1.28, CI =-2.28 to -0.28, p=0.013) and greater left leg muscle strength (B=0.16, CI=0.003 to 0.32, p=0.046) were linked to lower levels of fatigue independent of sex, age, time since treatment, pain and all other indicators of physical fitness. We observed that pain was associated with more fatigue (B = -6.80, CI = -11.45 to -2.15, p=0.005), decreased well-being (emotional: B = -1.92, CI =-3.50 to -0.35, p=0.018; global: B = -2.55, CI -4.59 to -0.51, p=0.015), decreased health related QoL (B =1.34, CI=0.42 to 2.26, p=0.005) and worse depression (B = 1.37, CI=-0.01 to 2.74, p=0.05), even when adjusting for sex, age, time since treatment and physical health and fitness. Depression was found to be an independent predictor of QoL with higher depression scores associated with greater fatigue (B = -2.52, CI=-3.09 to -1.96,p= Conclusions. Our findings confirm the important contribution of physical fitness to fatigue and QoL in these patients. Regardless of physical fitness status, however, the presence of pain and impaired psychological health remain independent drivers of fatigue and diminished QoL. Research involving exercise programmes designed to improve physical strength and fitness combined with effective pain management and psychological support are needed to provide the evidence base for much needed rehabilitative interventions. Disclosures Yong: Autolus Ltd: Equity Ownership, Patents & Royalties: APRIL based chimeric antigen receptor; Janssen: Research Funding.