PERCEPT myeloma: a protocol for a pilot randomised controlled trial of exercise prehabilitation before and during autologous stem cell transplantation in patients with multiple myeloma

Abstract

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.

Multiple myeloma and physical activity

“…With limited literatures available, more high-quality, large randomised studies are needed to evaluate the impact of PA on different health parameters of MM patients. Research protocols such as PREeMPT [ 21 ] and PERCEPT studies [ 22 ], which look at prehabilitation before ASCT, will provide information to support for the use of exercise intervention in the future. Although such programmes may be a positive way to influence PA, only 28% of our patients preferred to receive PA advice in a face-to-face session.…”

Multiple Myeloma and Physical Activity

“…With limited literatures on MM and PA available, more high-quality, large randomised studies are needed to evaluate the impact of PA on different health parameters of MM patients. Research protocols such as the PREeMPT study [19] and the PERCEPT myeloma [20], which look at prehabilitation for patients undergoing autologous haematopoietic stem cell transplantation, will provide information to support for the use of tailored exercise intervention in the future. Although such programmes may be a positive way to in uence PA, less than a third of our surveyed patients (28%) preferred a face-to-face session with a healthcare professional to receive PA advice.…”

The Role of Behavioral Science in Personalized Multimodal Prehabilitation in Cancer

“…and to foster patients' engagement for healthy lifestyles” p. 4 (Barberan-Garcia et al, 2020 ). Furthermore, in an ongoing trial described by McCourt et al ( 2020 ) the role of behavioral science is explicitly described. This study will investigate the feasibility of exercise-based prehabilitation prior to stem-cell transplantations in myeloma patients.…”

“…Importantly, some of the aforementioned studies also include qualitative process evaluations (Macleod et al, 2018 ; Brahmbhatt et al, 2020 ; McCourt et al, 2020 ). Brahmbhatt et al ( 2020 ) present findings from interviews with participants who had participated in a home-based exercise prehabilitation program prior to breast cancer surgery.…”

“…Motivation, lack of time, and the weather were identified as barriers to participation. McCourt et al ( 2020 ) plan to interview patients to explore experiences of involvement and patients who declined participation, to discuss experiences of being invited and their decision-making processes. This will afford important insights into the barriers and facilitators to involvement and enable refinement of future large-scale trials and/or services.…”