Cancer-Related FatigueFIBSNCT00552552
Development and Evaluation of a Cancer-Related Fatigue Patient Education Program
A study testing Fatigue Patient Education Program (FIBS) in people with Cancer-Related Fatigue, run by University of Bremen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-Related Fatigue
- What is being tested?
- Fatigue Patient Education Program (FIBS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult
- malign neoplasms
- ECOG performance status of 0-2
- moderate or severe fatigue
- stable condition after treatment
- German speaking
Who cannot join
- life expectancy < 1 year
- patients with brain neoplasms
- suicidal tendencies
- severe psychiatric disorders
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Cancer-Related Fatigue
- Being tested
- Fatigue Patient Education Program (FIBS)
- Keywords
- cancer-related fatigue, self-management, patient education, cancer survivors, chronic disease
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigue Patient Education Program (FIBS)Behavioural
Also called FIBS (Fatigue individuell bewältigen - ein Selbstmanagementprogramm)
6 weekly sessions, 90 min each
Fatigue Patient Education Program (FIBS)Behavioural
Also called FIBS (Fatigue individuell bewältigen - ein Selbstmanagementprogramm)
Participation in the program after the second follow-up
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Fatigue Patient Education Program (FIBS) |
| 2 | Other | waiting control group Receives: Behavioral: Fatigue Patient Education Program (FIBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Measured: Baseline, after the intervention, 6 months later
Secondary outcomes (1)
Quality of Life, Depression and anxiety, physical activity
Measured: Baseline, after the intervention, 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startJan 2008
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer-Related FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bremen
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Public Health and Nursing Research (IPP), German Federal Ministry of Education and Research, Bremer Krebsgesellschaft e.V.
- Investigators
- Karl Reif, Principal investigator, IPP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552552
- Sponsor's protocol ID
- 41100133
- Acronym
- FIBS
- Status last verified
- Oct 2007
- First submitted
- 31 Oct 2007
- Last updated
- 2 Nov 2007
- Results posted
- No
Publications
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.
PubMed 18651943
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Cancer-Related Fatigue Patient Education Program
- ClinicalTrials.gov ID
- NCT00552552
- Acronym / sponsor ID
- FIBS / 41100133
- Conditions
- Cancer-Related Fatigue
- Keywords
- cancer-related fatigue, self-management, patient education, cancer survivors, chronic disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of BremenUniversity, hospital or other
- Collaborators
- Institute of Public Health and Nursing Research (IPP), German Federal Ministry of Education and Research, Bremer Krebsgesellschaft e.V.
- Study start
- Jan 2008
- Study completion
- Dec 2009 (estimated)
- First posted
- 2 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Fatigue Patient Education Program (FIBS) |
| 2 | Other | Behavioral: Fatigue Patient Education Program (FIBS)waiting control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adult
- malign neoplasms
- ECOG performance status of 0-2
- moderate or severe fatigue
- stable condition after treatment
Key exclusion criteria (4 listed)
- life expectancy < 1 year
- patients with brain neoplasms
- suicidal tendencies
- severe psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatigue Patient Education Program (FIBS)Also: FIBS (Fatigue individuell bewältigen - ein Selbstmanagementprogramm)6 weekly sessions, 90 min each | Behavioural | 1 |
| Fatigue Patient Education Program (FIBS)Also: FIBS (Fatigue individuell bewältigen - ein Selbstmanagementprogramm)Participation in the program after the second follow-up | Behavioural | 2 |
Primary outcome
Fatigue
Time frame: Baseline, after the intervention, 6 months later
1 secondary outcome
Quality of Life, Depression and anxiety, physical activity
Time frame: Baseline, after the intervention, 6 months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2007.
- Derived from this study: PubMed 18651943Stuhldreher 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.
Related trials for Cancer-Related Fatigue
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Not yet recruiting
Evaluation of Massage Therapy for Cancer Related Fatigue in Breast Cancer Survivors
Breast Cancer, Fatigue in Cancer Survivors
Recruiting
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
Cancer Diagnosis, Moderate or Severe Score of Cancer-related Fatigue (CRF)
Active, not recruitingPhase 2/3
Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer
Prostate Carcinoma
RecruitingPhase 3
Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue
Brain Tumor, Pediatric, Cancer-related Fatigue
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Reif principal investigator
IPP
Questions about this trial
What is this clinical trial studying?
A study testing Fatigue Patient Education Program (FIBS) in people with Cancer-Related Fatigue, run by University of Bremen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl Reif (+49 421- 218 ext. 9055, karlreif@uni-bremen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: Baseline, after the intervention, 6 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00552552, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2007.