Ignite Creation Date:
2024-05-05 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00552552
Status:
UNKNOWN
Last Update Posted:
2007-11-02
First Post:
2007-10-31
Brief Title:
Development and Evaluation of a Cancer-Related Fatigue Patient Education Program
Sponsor:
University of Bremen
Organization:
University of Bremen
Study Overview
Official Title:
Development and Evaluation of a Cancer-Related Fatigue Patient Education Program
Status:
UNKNOWN
Status Verified Date:
2007-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIBS
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 hasnt 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
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 hasnt 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None