A Complex Intervention for Chronically Fatigued Lymphoma Survivors

NCT ID: NCT05130099

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-20
• Study Completion Date: 2025-06-30

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.

Detailed Description

Chronic fatigue (CF) is a subjective experience of substantial lack of energy, exhaustion and cognitive difficulties lasting for six months or longer. CF is one of the most common and distressing late effects after cancer, affecting 15-35 % of survivors, often for years beyond treatment. Despite the high prevalence and the huge negative consequences of CF on daily functioning and QoL and the economic and societal costs, effective treatment of CF and standardized follow-up care are currently lacking.

Today, there is no curative treatment of CF. However, several modifiable behavioral factors including emotional distress, physical inactivity, sleep disturbances and unhealthy diets are found to be associated with CF. So far, most of the interventions aiming to reduce fatigue during and shortly after cancer treatment have targeted only one of these factors at a time, with small to moderate effect sizes. No prior study has examined if CF in cancer survivors is better treated by a complex intervention targeting combinations of these factors, an approach which seems logical due to the complexity of the symptom.

The project is a two-armed RCT in which chronically fatigued lymphoma survivors are randomized to an interdisciplinary complex intervention or to usual care. Eligible participants will receive written information about the study by mail. Survivors who perceive themselves as having physical and mental fatigue, and who are willing to participate, will be asked to fill out and return the Chalder Fatigue Questionnaire (FQ) to the study coordinator. Those who have chronic fatigue as measured by the FQ will be invited to a medical screening by an oncologist in the project group, for evaluation of inclusion.

The interdisciplinary complex intervention will last for 12 + 12 weeks and include four components; patient education, physical exercise (and follow-up), cognitive behavioral program and nutritional counselling, organized in a systematic way, i.e. a standardized patient care pathway.

All outcomes will be assessed in all participants at four points; pre-intervention (baseline) (T0), post-intervention (12 weeks after baseline) (T1) and at 3-month (T2) and 6-month (T3) after T1. Moreover, selected patient reported outcomes will be assessed in all participants at 12-month (T4) and 24-month (T5) after T1.

Conditions

Chronic Fatigue Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Interdisciplinary complex intervention

Group Type: EXPERIMENTAL

Interdisciplinary complex intervention

Intervention Type: 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.

Usual care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Interdisciplinary complex intervention

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Norwegian School of Sport Sciences

OTHER

Sponsor Role: collaborator

UiT The Arctic University of Norway

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lene Thorsen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oslo University Hospital

Oslo, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 40882189 (View on PubMed)

Other Identifiers

#153665

Identifier Type: -

Identifier Source: org_study_id