Development and Evaluation of a Cancer-Related Fatigue Patient Education Program
NCT ID: NCT00552552
Last Updated: 2007-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2008-01-31
2009-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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1
Fatigue Patient Education Program (FIBS)
6 weekly sessions, 90 min each
2
waiting control group
Fatigue Patient Education Program (FIBS)
Participation in the program after the second follow-up
Interventions
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Fatigue Patient Education Program (FIBS)
6 weekly sessions, 90 min each
Fatigue Patient Education Program (FIBS)
Participation in the program after the second follow-up
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* malign neoplasms
* ECOG performance status of 0-2
* moderate or severe fatigue
* stable condition after treatment
* German speaking
Exclusion Criteria
* patients with brain neoplasms
* suicidal tendencies
* severe psychiatric disorders
18 Years
ALL
No
Sponsors
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Institute of Public Health and Nursing Research (IPP)
UNKNOWN
German Federal Ministry of Education and Research
OTHER_GOV
Bremer Krebsgesellschaft e.V.
UNKNOWN
University of Bremen
OTHER
Principal Investigators
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Karl Reif
Role: PRINCIPAL_INVESTIGATOR
IPP
Central Contacts
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References
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Stuhldreher N, Reif K, de Vries U, Gorres S, Petermann F. Development and evaluation of a cancer-related fatigue patient education program: protocol of a randomized controlled trial. BMC Nurs. 2008 Jul 23;7:12. doi: 10.1186/1472-6955-7-12.
Other Identifiers
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41100133
Identifier Type: -
Identifier Source: org_study_id