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A Complex Intervention for Chronically Fatigued Lymphoma Survivors

NCT05130099 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-04-08

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER

  • Norwegian School of Sport Sciences

    collaborator OTHER

  • UiT The Arctic University of Norway

    collaborator OTHER

  • Norwegian University of Science and Technology

    collaborator OTHER

  • Diakonhjemmet Hospital

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-20
Primary Completion
2023-06-30
Completion
2025-06-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05130099 on ClinicalTrials.gov