A Complex Intervention for Chronically Fatigued Lymphoma Survivors

University of Oslo (UIO)

Status: Active, not recruiting

Conditions: Chronic Fatigue Syndrome

Treatments: Other: Interdisciplinary complex intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05130099

#153665

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Interdisciplinary complex intervention

Experimental group

Treatment:

Other: Interdisciplinary complex intervention

Usual care

No Intervention group

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.