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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
University of Bremen
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

    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.
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    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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