Effects of a Multidisciplinary Intervention on Fatigue in Lymphoma Survivors With Chronic Fatigue: Protocol for a Randomized Controlled Trial (REFUEL)
Bibliographic record
Abstract
BACKGROUND: Chronic fatigue (CF) is a highly disabling late effect after cancer, affecting 25% to 40% of lymphoma survivors years after cancer treatment. There is a lack of randomized controlled trials testing interventions to reduce fatigue levels among survivors with CF. OBJECTIVE: The primary aim of the Randomized Controlled Trial in Chronically Fatigued Lymphoma Survivors (REFUEL) is to examine the effects of a multidisciplinary intervention on the level of fatigue among lymphoma survivors with CF before and immediately after the intervention (3 months after randomization). Secondary aims are to (1) investigate the effects of the intervention on the level of fatigue 6 and 9 months after randomization and the effects on health-related quality of life (HRQoL); other patient-reported outcome measures; and physical fitness 3, 6, and 9 months after randomization; (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 measure changes in fatigue, daily functioning, HRQoL, mental health, and work-life balance management within each group at 1- and 2-year follow-ups. METHODS: The REFUEL trial is a 2-armed randomized controlled trial. Lymphoma survivors (2-12 years after diagnosis) with CF are randomly allocated to a 12-week multidisciplinary intervention including patient education, physical exercise, a cognitive behavioral therapy-based group program, and individual nutrition counseling or to usual care. Fatigue is measured by the Chalder Fatigue Questionnaire. Other patient-reported outcome measures are measured by validated questionnaires (eg, the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire, the Patient Health Questionnaire-9, and the Generalized Anxiety Disorder-7). Cardiorespiratory fitness is measured as peak oxygen consumption during a cardiopulmonary exercise test or indirectly using a modified Balke treadmill protocol. Muscle strength is assessed by push-ups and leg press. The primary analyses will be performed using a generalized linear mixed model for repeated measures, with an intention-to-treat approach. RESULTS: A total of 150 survivors were included from December 2021 to March 2023. Three-month postrandomization assessments were completed in June 2023 and 2-year follow-up assessments were completed in June 2025. CONCLUSIONS: The REFUEL trial will provide new and highly needed scientific evidence about the effects of a multidisciplinary intervention on the level of fatigue and secondary outcomes regarding HRQoL aspects among lymphoma survivors with CF. TRIAL REGISTRATION: ClinicalTrials.gov NCT05130099; https://www.clinicaltrials.gov/study/NCT05130099. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/69336.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.029 | 0.032 |
| Meta-epidemiology (narrow) | 0.008 | 0.003 |
| Meta-epidemiology (broad) | 0.014 | 0.008 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.005 | 0.004 |
| Scholarly communication | 0.004 | 0.004 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.010 | 0.009 |
| Insufficient payload (model declined to judge) | 0.059 | 0.008 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".