Effects of an interdisciplinary intervention on fatigue in lymphoma survivors with chronic fatigue: Design of the randomized controlled REFUEL-trial (Preprint)
Authors: Bøhn Synne-Kristin Hoffart , Reinertsen Kristin V , Kiserud Cecilie E , Loge Jon Håvard , Fosså Alexander , Skaali Tone , Blomhoff Rune , Oldervoll Line Merethe , Courneya Kerry S , Raastad Truls , Nilsen Tormod S , Wisløff Torbjørn , Lie Hanne Cathrine , Berge Torkil , Edvardsen Elisabeth , Fagerli Unn-Merete , Fjerstad Elin , Gjerset Gunhild Maria , Haavik Ingvild , Henriksen Hege Berg , Rutkovskiy Arkady , Sandberg Gro , Seland Mette , Slott Malene , Tjessem Kristin Holm , Viktil Linn , Thorsen Lene 
Published: December 2024

BACKGROUND

Chronic fatigue (CF) is a highly disabling late effect after cancer, affecting 25-40% of lymphoma survivors years after cancer treatment. There is a lack of randomized controlled trials (RCTs) testing interventions to reduce fatigue levels among survivors with CF.

OBJECTIVE

The primary aim of the randomized controlled REFUEL-trial is to examine the effects of an interdisciplinary intervention on the level of fatigue among lymphoma survivors with CF from pre- to immediately post-intervention. Secondary aims are to 1) investigate the effects of the intervention on level of fatigue three and six months post-intervention, and the effects on health-related quality of life (HRQoL), other patient-reported outcomes and physical fitness immediately, three and six months post-intervention, 2) evaluate the cost-utility of the intervention, 3) examine the effect of the intervention on HRQoL among the survivors’ partners and 4) investigate the long-term perceived benefits and daily use of acquired self-management strategies, as well as changes in fatigue, daily functioning, HRQoL, mental health, and work-life within each group at 12 and 24 months post-intervention.

METHODS

The REFUEL-trial is a two-armed RCT. Lymphoma survivors (2-12 years post-diagnosis) with CF are randomly allocated to a 12-week interdisciplinary intervention including patient education, physical exercise, a cognitive behavioral therapy-based group program and individual nutrition counselling, or to usual care. Fatigue is measured by the Chalder Fatigue Questionnaire. Other patient-reported outcomes are measured by validated questionnaires (e.g. European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), The Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7)). Cardiorespiratory fitness is measured as peak oxygen consumption (VO2peak) during a cardiopulmonary exercise test, or indirectly using a modified Balke treadmill protocol. Muscle strength is assessed by push-ups and leg press.

RESULTS

A total of 150 survivors were included from December 2021 to March 2023. Post-intervention assessments were completed in June 2023, and 24 months follow-up will be completed in June 2025.

CONCLUSIONS

The REFUEL-trial will provide new and highly needed scientific evidence about the effects of an interdisciplinary intervention for lymphoma survivors with CF, their partners, and cost-utility for society.

CLINICALTRIAL

The study is preregistered on clinicaltrials.gov (NCT05130099).