A Feasibility Study in Chronically Fatigued Cancer Survivors

NCT04931407 | Completed

• 1 other identifier: 153665
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Improved cancer survival has led to increased attention on long-term health and quality of life (QoL) among the survivors. Both the cancer diagnosis and intensive treatments increase the risk of late effects which may interfere with daily physical, psychological and social functioning, and thereby negatively affect their QoL. Well-documented late-effects among cancer survivors are second cancer, cardio-vascular disease, pain, hormone disturbances, mental distress and chronic fatigue (CF). 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. CF is a complex condition best understood as a multifactorial phenomenon. Our and other research groups have examined various cohorts of cancer survivors in order to identify behavioral-, psychological-, and biological factors associated with CF, that can form the basis for targeted interventions. So far, few treatable biological factors have been identified, even though immune activation, flattened diurnal cortisol slopes and a blunted cortisol response to stress have been demonstrated in small studies among cancer survivors suffering from CF. On the other hand, 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 Division of Cancer Medicine at Oslo University Hospital (OUH) presently offers limited rehabilitation programs, including patient education, physical exercise, cognitive behavioral program and nutrition counselling to cancer survivors with CF. However, these programs are not offered as an interdisciplinary intervention integrated in a standardized patient care pathway, and the effects of these interventions have not been assessed. Based on the investigators clinical experience and published studies on single-targeted interventions, the investigators hypothesize that a complex intervention including psycho-educational elements, physical exercise and nutrition counseling delivered as a standardized patient care pathway is well-founded and doable, and will improve fatigue, functioning and QoL in cancer survivors with CF. During the fall of 2021, the investigators will conduct a randomized controlled trial (RCT) with the overall objective to improve fatigue in lymphoma survivors with CF. To uncover strengths and weaknesses with the planned RCT, i.e. the inclusion procedures, the assessments and the complex intervention, the investigators are now conducting a small one-armed feasibility study before the RCT during spring 2021.

Conditions

Fatigue; Lymphoma

Keywords

exercise; chronic fatigue; lymphoma; cancer survivors; nutrition; cognitive therapy; patient education

Outcome Measures

Primary Outcomes (27)

• Recruitment rate

  Assessed by the number who consent to participate

  The week before the intervention period (week 0)

• Inclusion rate

  Assessed by the number of consenting participants who are included (i.e. have chronic fatigue according to the Fatigue Questionnaire, and are cleared for participation by oncologist after the medical screening).

  The week before the intervention period (week 0)

• Completion rate

  Assessed by the number of consenting participants consenting patients who complete any measurement at the final assessment

  The week before the intervention period (week 0)

• Strengths and weaknesses with the inclusion procedure: participants

  Assessed by structured conversations with the participants

  Week 4

• Strengths and weaknesses with the inclusion procedure: study personnel

  Assessed by structured conversations with the study personnel

  Week 4

• Feasibility of the patient education session: participants

  Strengths, weaknesses, and usefulness of the contents in the education session will be assessed by structured conversations with the participants after the patient education session.

  Week 4

• Feasibility of the patient education session: presenters

  Strengths, weaknesses, and usefulness of the contents in the education session will be assessed by structured conversations with the presenters after the patient education session.

  Week 4

• Feasibility of the exercise program part one (week 1-3): participants

  Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants

  Week 4

• Feasibility of the exercise program part one (week 1-3): physiotherapists

  Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists

  Week 4

• Feasibility of the exercise program part two (week 4-7): participants

  Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants

  Week 8

• Feasibility of the exercise program part two (week 4-7): physiotherapists

  Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists

  Week 8

• Compliance to the cognitive behavioral therapy groups sessions

  Participation to the cognitive behavioral therapy groups sessions will be registered by the study coordinators/psychologists..

  Week 8

• Feasibility of the cognitive behavioral therapy groups sessions: participants

  Strengths, weaknesses, and usefulness of the groups sessions will be assessed by structured conversations with the participants after the last group session

  Week 8

• Feasibility of the cognitive behavioral therapy groups sessions: psychologists

  Strengths, weaknesses, and usefulness of the groups sessions will be assessed by structured conversations with the psychologists after the last group session

  Week 8

• Compliance to the nutrition counseling

  Participation rate of the individual nutrition counseling sessions will be registered by the clinical dietitian.

  Week 11

• Feasibility of the nutrition counseling: participants

  Strengths, weaknesses, and usefulness of the contents in the sessions will be assessed by structured conversations with the participants after the last counseling session.

  Week 11

• Feasibility of the nutrition counseling: clinical dietitian

  Strengths, weaknesses, and usefulness of the contents in the sessions will be assessed by structured conversations with the clinical dietitian after the last counseling session.

  Week 11

• Compliance to the exercise program: attendance

  Registered by the physiotherapists in an exercise log

  Week 13

• Compliance to the exercise program: intensity during the aerobic exercise intervals

  Registered by pulse sensors

  Week 13

• Compliance to the exercise program: implementation of the strength training exercises

  Registered by the physiotherapists in an exercise log

  Week 13

• Feasibility of the exercise program part three (week 8-12): participants

  Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants

  Week 13

• Feasibility of the exercise program part three (week 8-12): physiotherapists

  Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists

  Week 13

• Feasibility of the questionnaires

  Strengths and weaknesses with the questionnaire will be evaluated through structured conversations with the participants.

  Week 13

• Feasibility of the physical tests: participants

  Strengths and weaknesses with the tests will be evaluated through structured conversations with the participants.

  Week 13

• Feasibility of the physical tests: physiotherapists

  Strengths and weaknesses with the tests will be evaluated through structured conversations with the physiotherapists conducting the tests.

  Week 13

• Compliance to the physical tests

  Assessed by the completion rate of the physical tests (i.e. the number of participants who conduct the tests as planned).

  Week 13

• Completeness of the questionnaires

  Assessed by the completion rate of the questionnaire (i.e. proportion of missing).

  Week 13

Secondary Outcomes (43)

• Change in level of fatigue

  Change from baseline (week 0) and to post-intervention (week 13)

• Change in level of fatigue

  Change from baseline (week 0) to 4 months follow-up (week 29)

• Change in level of fatigue

  Change from baseline (week 0) to 7 months follow-up (week 42)

• Change in daily functioning and global quality of life

  Change from baseline (week 0) and to post-intervention (week 13)

• Change in daily functioning and global quality of life

  Change from baseline (week 0) to 4 months follow-up (week 29)

Study Arms (1)

Interdisciplinary complex intervention

EXPERIMENTAL

The intervention includes patient education, physical exercise, a group-based cognitive behavioral program and individual nutritional counseling

Other: A 12-week interdisciplinary complex intervention

Interventions

A 12-week interdisciplinary complex intervention OTHER

The intervention will last for 12 weeks and includes four components; patient education, physical exercise, cognitive behavioral program and nutritional counseling. The patient education will include an online 2-hours group-based patient-education sessions in week 1. The physical exercise program includes two weekly exercise sessions, one supervised by a physiotherapist and one unsupervised, including aerobic exercise, resistance exercise and psychometric physiotherapy. Half of the intervention group (N=7) will perform the supervised exercise session individually with a physiotherapist in the municipality, while the other half (n=8) will exercise in online groups lead by physiotherapists. The cognitive behavioral program will begin in week 3 and include six group-based online sessions every week lead by a clinical psychologist. The nutritional counseling will include three individual digital nutrition counselling sessions in week 2, 6 and 10 by a clinical dietitian.

Interdisciplinary complex intervention

Eligibility Criteria

• Age: 19 Years - 67 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, diagnosed 2014 or 2019 (n=7)
• years at diagnosis, and 19-67 years at participation.
• CF measured by Chalder FQ.
• Curatively treated, more than 2 years since last treatment.
• Participation approval from oncologist.

You may not qualify if:

• Indolent non-Hodgkin lymphoma.
• Fatigue more than one year before the cancer diagnosis.
• Ongoing cancer treatment, relapse or second cancer, somatic/physical conditions (i.e. severe heart failure/disease, lung disease, use of wheelchair /crutches).
• Psychiatric disorders (i.e. severe depression, schizophrenia), substance abuse disorder.
• In addition, eight cancer survivors with various diagnosis, will be included from a waiting list for rehabilitation at the Cancer Rehabilitation Centre at Aker hospital.

Sponsors & Collaborators

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

Study Sites (1)

Oslo University Hospital

Oslo, 0379, Norway

Location

Related Publications (1)

• Bohn S, Oldervoll LM, Reinertsen KV, Seland M, Fossa A, Kiserud C, Skaali T, Nilsen TS, Blomhoff R, Henriksen HB, Lie HC, Berge T, Fjerstad E, Wisloff T, Slott M, Zajmovic I, Thorsen L. The feasibility of a multidimensional intervention in lymphoma survivors with chronic fatigue. Support Care Cancer. 2023 Dec 14;32(1):22. doi: 10.1007/s00520-023-08204-5.

  PMID: 38095797 DERIVED

MeSH Terms

Conditions

Fatigue; Lymphoma; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms; 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 Officials

• Lene Thorsen

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: June 18, 2021
• Study Start: April 6, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: April 21, 2022

Record last verified: 2022-04

Locations

NO (1)