NCT00552552

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 2, 2007

Status Verified

October 1, 2007

First QC Date

October 31, 2007

Last Update Submit

November 1, 2007

Conditions

Cancer-Related Fatigue

Keywords

cancer-related fatigueself-managementpatient educationcancer survivorschronic disease

Outcome Measures

Primary Outcomes (1)

  • Fatigue

    Baseline, after the intervention, 6 months later

Secondary Outcomes (1)

  • Quality of Life, Depression and anxiety, physical activity

    Baseline, after the intervention, 6 months later

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Fatigue Patient Education Program (FIBS)

2

OTHER

waiting control group

Behavioral: Fatigue Patient Education Program (FIBS)

Interventions

Fatigue Patient Education Program (FIBS)BEHAVIORAL

6 weekly sessions, 90 min each

Also known as: FIBS (Fatigue individuell bewältigen - ein Selbstmanagementprogramm)
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult
  • malign neoplasms
  • ECOG performance status of 0-2
  • moderate or severe fatigue
  • stable condition after treatment
  • German speaking

You may not qualify if:

  • life expectancy \< 1 year
  • patients with brain neoplasms
  • suicidal tendencies
  • severe psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 18651943DERIVED

MeSH Terms

Conditions

Chronic Disease

Interventions

FIBS

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Karl Reif

    IPP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karl Reif

CONTACT

+49 421- 218karlreif@uni-bremen.de

Nina Egger

CONTACT

+49 421- 218negger@uni-bremen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2007

First Posted

November 2, 2007

Study Start

January 1, 2008

Study Completion

December 1, 2009

Last Updated

November 2, 2007

Record last verified: 2007-10