Development and Evaluation of a Cancer-Related Fatigue Patient Education Program (FIBS)

November 1, 2007 updated by: University of Bremen
The objective of this study is to develop a structured and evidence-based self-management program to cope with cancer-related fatigue and to assess the efficacy of the intervention in cancer survivors.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background

Cancer-related fatigue (CRF) and its impact on patients quality of life has been an increasing subject of research. However, in Germany exists a lack of evidence-based interventions consistent with the multidimensional character of fatigue. The objective of this study is to develop and evaluate a self-management program for disease-free cancer patients to cope with CRF.

Methods

Based on evidence extracted from a literature review a curriculum for the self-management program was elaborated. The curriculum is currently being reviewed and validated by an expert group of oncologists, psycho-oncologists, nurses, social workers, physical therapists, health scientists, and patients. The modules will be pretested with a small number of patients, discussed in terms of feasibility and acceptance.

To determine the efficacy of the program a randomised controlled trial will be conducted: 300 patients will be allocated to an intervention or a waiting control group. Data will be collected before randomisation, after intervention, and after a follow-up of 6 months.

Results

As essential subjects for the curriculum were identified:

  • medical background and causes of CRF
  • physical activity and moderate exercise
  • restructuring daily schedules
  • energy conservation
  • stress-management and relaxation strategies
  • coping with negative emotions
  • integrating the new knowledge into every day life.

The program aims at impacting on health-related self-efficacy by the training of problem solving, goal setting, and cognitive techniques as knowledge transfer hasn't proved sufficient to achieve changes in behaviour. According to this we developed a curriculum wherein detailed information for every module concerning objectives, background, didactic methods and materials are provided. Based on the curriculum train-the-trainer seminars are held in order to educate on moderation techniques, group dynamics, and clinical background of CRF. The program will be administered by qualified health professionals in groups of eight patients. It includes six weekly sessions 90 minutes each dealing with the topics listed above.

The results of the pre-test are currently being analysed.

Discussion

Due to the fact that there are no comparable self-management programs for cancer survivors with fatigue the development of the curriculum has been complex. Therefore the critical appraisal by the experts was an important step to validate the program: their contributions have been integrated into the curriculum. The experts appreciated the program as filling in a gap of outpatient cancer care.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult
  • malign neoplasms
  • ECOG performance status of 0-2
  • moderate or severe fatigue
  • stable condition after treatment
  • German speaking

Exclusion Criteria:

  • life expectancy < 1 year
  • patients with brain neoplasms
  • suicidal tendencies
  • severe psychiatric disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Behavioral: Fatigue Patient Education Program (FIBS)
6 weekly sessions, 90 min each
Other Names:
  • FIBS (Fatigue individuell bewältigen - ein Selbstmanagementprogramm)
Behavioral: Fatigue Patient Education Program (FIBS)
Participation in the program after the second follow-up
Other Names:
  • FIBS (Fatigue individuell bewältigen - ein Selbstmanagementprogramm)
Other: 2
waiting control group
Behavioral: Fatigue Patient Education Program (FIBS)
6 weekly sessions, 90 min each
Other Names:
  • FIBS (Fatigue individuell bewältigen - ein Selbstmanagementprogramm)
Behavioral: Fatigue Patient Education Program (FIBS)
Participation in the program after the second follow-up
Other Names:
  • FIBS (Fatigue individuell bewältigen - ein Selbstmanagementprogramm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fatigue
Time Frame: Baseline, after the intervention, 6 months later
Baseline, after the intervention, 6 months later

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life, Depression and anxiety, physical activity
Time Frame: Baseline, after the intervention, 6 months later
Baseline, after the intervention, 6 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bremen

Collaborators

German Federal Ministry of Education and Research
Institute of Public Health and Nursing Research (IPP)
Bremer Krebsgesellschaft e.V.

Investigators

  • Principal Investigator: Karl Reif, IPP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

October 31, 2007

First Submitted That Met QC Criteria

November 1, 2007

First Posted (Estimate)

November 2, 2007

Study Record Updates

Last Update Posted (Estimate)

November 2, 2007

Last Update Submitted That Met QC Criteria

November 1, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 41100133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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