A Complex Intervention for Chronically Fatigued Lymphoma Survivors

NCT05130099 | Active Not Recruiting

• 1 other identifier: #153665
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Chronic Fatigue Syndrome

Keywords

lymphoma; cancer survivorship; physical activity; nutrition; patient education; cognitive behavioral program

Outcome Measures

Primary Outcomes (1)

• Difference in change in fatigue levels (physical-, mental- and total fatigue) between intervention and control group, assessed by the Chalder Fatigue Questionnaire

  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.

  From baseline (T0) to 12 weeks (T1)

Secondary Outcomes (83)

• Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire

  From baseline (T0) to 24 weeks (T2)

• Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire

  From baseline (T0) to 36 weeks (T3)

• Change in fatigue levels among all participants assessed by Chalder Fatigue Questionnaire

  From post-intervention (T1) to 12-month follow-up (T4)

• Change in fatigue levels among all participants assessed by Chalder Fatigue Questionnaire

  From post-intervention (T1) to 24-month follow-up (T5)

• Difference in change in daily functioning between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).

  From baseline (T0) to 12 weeks (T1)

Study Arms (2)

Interdisciplinary complex intervention

EXPERIMENTAL

Other: Interdisciplinary complex intervention

Usual care

NO INTERVENTION

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.

Interventions

Interdisciplinary complex intervention OTHER

The interdisciplinary complex intervention lasts 12 weeks and includes the 4 following components; Patient-education: a 2-hours group-based digital session, including information about fatigue, training theory, psychological strategies and nutrition, all in relation to chronic fatigue (CF). Physical exercise program: two weekly sessions with aerobic exercise and resistance training. The participants are instructed to do the same program in the unsupervised sessions as in the supervised sessions. After the first 12 weeks exercise period, the participant and the physiotherapist makes an individually tailored plan for exercise and follow-up the next 12 weeks. Cognitive behavioral program: 6 group-based online sessions lead by two psychologists, based on elements from cognitive behavioral therapy to reduce and/or manage CF. Each session lasts for 135 minutes. Nutritional counselling: 3 individual sessions by a clinical dietitian. Each session lasts for 30-60 minutes.

Interdisciplinary complex intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \> 2 years since last treatment
• Able to understand the Norwegian language
• Participation approval from oncologist in the project group

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator
• Norwegian School of Sport Sciences: collaborator
• UiT The Arctic University of Norway: collaborator
• Norwegian University of Science and Technology: collaborator
• Diakonhjemmet Hospital: collaborator
• University of Alberta: collaborator
• St. Olavs Hospital: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

• Bohn 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 DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Lymphoma; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 22, 2021
• Study Start: November 20, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2025
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

NO (1)