Development and Evaluation of a Cancer-Related Fatigue Patient Education Program (FIBS)
Primary Purpose
Cancer-Related Fatigue
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fatigue Patient Education Program (FIBS)
Fatigue Patient Education Program (FIBS)
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer-Related Fatigue focused on measuring cancer-related fatigue, self-management, patient education, cancer survivors, chronic disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
1
2
Arm Description
waiting control group
Outcomes
Primary Outcome Measures
Fatigue
Secondary Outcome Measures
Quality of Life, Depression and anxiety, physical activity
Full Information
NCT ID
NCT00552552
First Posted
October 31, 2007
Last Updated
November 1, 2007
Sponsor
University of Bremen
Collaborators
Institute of Public Health and Nursing Research (IPP), German Federal Ministry of Education and Research, Bremer Krebsgesellschaft e.V.
1. Study Identification
Unique Protocol Identification Number
NCT00552552
Brief Title
Development and Evaluation of a Cancer-Related Fatigue Patient Education Program
Acronym
FIBS
Official Title
Development and Evaluation of a Cancer-Related Fatigue Patient Education Program
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bremen
Collaborators
Institute of Public Health and Nursing Research (IPP), German Federal Ministry of Education and Research, Bremer Krebsgesellschaft e.V.
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-Related Fatigue
Keywords
cancer-related fatigue, self-management, patient education, cancer survivors, chronic disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Other
Arm Description
waiting control group
Intervention Type
Behavioral
Intervention Name(s)
Fatigue Patient Education Program (FIBS)
Other Intervention Name(s)
FIBS (Fatigue individuell bewältigen - ein Selbstmanagementprogramm)
Intervention Description
6 weekly sessions, 90 min each
Intervention Type
Behavioral
Intervention Name(s)
Fatigue Patient Education Program (FIBS)
Other Intervention Name(s)
FIBS (Fatigue individuell bewältigen - ein Selbstmanagementprogramm)
Intervention Description
Participation in the program after the second follow-up
Primary Outcome Measure Information:
Title
Fatigue
Time Frame
Baseline, after the intervention, 6 months later
Secondary Outcome Measure Information:
Title
Quality of Life, Depression and anxiety, physical activity
Time Frame
Baseline, after the intervention, 6 months later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karl Reif
Phone
+49 421- 218
Ext
9055
Email
karlreif@uni-bremen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Egger
Phone
+49 421- 218
Ext
3500
Email
negger@uni-bremen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Reif
Organizational Affiliation
IPP
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
18651943
Citation
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.
Results Reference
derived
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Development and Evaluation of a Cancer-Related Fatigue Patient Education Program
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