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

University of Bremen

Status: Unknown

Conditions: Cancer-Related Fatigue

Treatments: Behavioral: Fatigue Patient Education Program (FIBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT00552552

41100133

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

300 participants in 2 patient groups

1

Experimental group

Treatment:

Behavioral: Fatigue Patient Education Program (FIBS)

Behavioral: Fatigue Patient Education Program (FIBS)

2

Other group

Description:

waiting control group

Treatment:

Behavioral: Fatigue Patient Education Program (FIBS)

Behavioral: Fatigue Patient Education Program (FIBS)