Clinical trial · Interventional
A Complex Intervention for Chronically Fatigued Lymphoma Survivors
A Complex Intervention for a Complex Symptom - a Randomized Controlled Trial in Chronically Fatigued Lymphoma Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The present study is a randomized controlled trial (RCT) with an overall objective to examine the effect of an interdisciplinary complex intervention on the level of fatigue in lymphoma survivors with chronic fatigue. Secondary aims are to examine the effects of the intervention on daily functioning, work status/ability, physical fitness and QoL among the survivors, on QoL of their relatives and on the societal costs.The intervention will last for 12+12 weeks and include four components; patient education, supervised physical exercise, cognitive behavioral program and nutritional counselling. Outcomes will be assessed at baseline,post-intervention (12 weeks after baseline) and at 3-month, 6-month, 12-month and 24-month follow-up after completed intervention.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Fatigue Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interdisciplinary complex intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interdisciplinary complex intervention
- interventionNames
- Other: Interdisciplinary complex intervention
- type
- NO_INTERVENTION
- label
- Usual care
- description
- Six months after the intervention period (T3), the participants randomized to usual care will be offered a modified version of the intervention in line with their personally expressed needs.
Primary outcomes (1)
- measure
- Difference in change in fatigue levels (physical-, mental- and total fatigue) between intervention and control group, assessed by the Chalder Fatigue Questionnaire
- timeFrame
- From baseline (T0) to 12 weeks (T1)
- description
- The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3. This provides a physical fatigue score from 0 to 21, mental fatigue score from 0 to 12, and total score from 0 to 33. Higher score implies more fatigue.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Survivors of Hodgkin and aggressive non-Hodgkin lymphoma * Not indolent non-Hodgkin lymphoma * Not CNS lymphoma at diagnosis * Not second cancer * Not ongoing cancer treatment * Chronic fatigue measured by Chalder Fatigue Questionnaire * Diagnosed 2010-2020 * Received treatment with curative intent * 18 - 70 years old at inclusion * \> 2 years since last treatment * Able to understand the Norwegian language * Participation approval from oncologist in the project group Exclusion Criteria: * Persisting fatigue \> 1 year before the cancer diagnosis * Somatic/physical conditions (i.e. severe heart failure/disease, lung disease, use of wheelchair /crutches) * Psychiatric or mental disorders (i.e. dementia, severe depression, schizophrenia) * Use of stimulants for ADHD * Substance abuse disorder
References
Publications (1)
- DERIVEDBohn SH, Reinertsen KV, Kiserud CE, Loge JH, Fossa A, Skaali T, Blomhoff R, Oldervoll LM, Courneya KS, Raastad T, Nilsen TS, Wisloff T, Lie HC, Berge T, Edvardsen E, Fagerli UM, Fjerstad E, Gjerset GM, Haavik I, Henriksen HB, Rutkovskiy A, Sandberg G, Seland M, Slott M, Tjessem KH, Viktil L, Thorsen L. Effects of a Multidisciplinary Intervention on Fatigue in Lymphoma Survivors With Chronic Fatigue: Protocol for a Randomized Controlled Trial (REFUEL). JMIR Res Protoc. 2025 Aug 29;14:e69336. doi: 10.2196/69336. PMID 40882189