Relaxation and Exercise in Lymphoma Survivors (REIL Study): A Randomised Clinical Trial Protocol

Abstract

Background: Cancer survivors commonly report ongoing physical and psychological needs and adverse effects due to disease and treatment exposures including fatigue, pain, depression and decreased quality of life (QoL). Both relaxation and exercise interventions have demonstrated a positive effect on these symptoms. However these benefits have been relative to a control group, and there has been a call for further intervention studies in survivors to move beyond wait-list control groups and to compare with active control or other empirically supported interventions, such as comparison of relaxation to exercise intervention, to determine which is more beneficial. Aim: This paper presents the REIL (Relaxation and Exercise In Lymphoma) study protocol using recommended SPIRIT 2013 guidelines. The primary aim of the REIL Study is to compare the effect of two interventions - exercise and relaxation on QoL in a sample of lymphoma patients in remission postchemotherapy. Secondary aims are to investigate the effects of the two interventions on body composition, cardiovascular status, pulmonary function, muscle strength, functional exercise capacity, well-being and psychological status; and explore perceptions about participation in the posttreatment intervention program. Methods: Eligible participants (n=36) will be randomized to an exercise or relaxation home-based program to perform at least three times per week. The primary outcome measure is QoL, assessed by the European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC QLQ-C30). Secondary outcome measures include body composition, cardiovascular status, pulmonary function, strength, functional exercise capacity, well-being and psychological status. Total duration of the study will be 12 weeks and outcome measures will be assessed at baseline, 6 weeks and at the end of the study. Results: Results from this study will inform development of effective care pathways for the increasing population of cancer survivors in general, and lymphoma in particular. It is anticipated that preliminary results from this study will be available by October 2018. Conclusion: Although it is well documented that cancer survivors commonly suffer from consequences of treatment which have a negative impact on their QoL, there are currently no recommended care pathways following completion of primary medical treatment. Evidence suggests that both relaxation and exercise can significantly improve ongoing symptoms in cancer survivors, but there is no consensus on which intervention is more effective. Results from the REIL study will aid in the development of evidence-based survivorship care pathways for cancer and lymphoma survivors, potentially prevent long-term complications, and help in a smooth transition from being a cancer patient to a fully-functioning member of society. This may lead to reduced use of healthcare resources by this population.