Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue

March 29, 2010 updated by: Charite University, Berlin, Germany

Effects of a Brief Endurance Exercise Program and of a Cognitive Behavioural Therapy on Patients With Cancer-related Fatigue

The investigators compare the effects of two interventions, an endurance exercise program and a cognitive behavioural therapy, on the fatigue, quality of life, mood and physical performance of patients with a cancer-related fatigue syndrome. The intervention will be carried out for 4 weeks. Tests will be carried out at the beginning and at the end of the study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-70
  • Histologically confirmed neoplastic disease
  • Treatment (chemotherapy or radiation) completed.
  • No treatment in the previous 4 weeks
  • Ability to understand written German

Exclusion Criteria:

  • Health conditions which can be aggravated by exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Cognitive behavioural therapy
Behavioral: Cognitive behavioural therapy
Teaching of techniques to reduce fatigue and to improve stamina
EXPERIMENTAL: Exercise
Endurance training (walking on a treadmill) 3 x weekly for 4 weeks
Behavioral: Exercise
Endurance exercise 3 times weekly for 45 minutes, 4 weeks long

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fatigue scores on the Brief Fatigue Inventory (BFI)
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximal oxygen uptake (VO2max) on a treadmill stress test.
Time Frame: 4 weeks
4 weeks
Scores on the HADS (Hospital Anxiety and Depression Scale)
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ANTICIPATED)

July 1, 2010

Study Completion (ANTICIPATED)

September 1, 2010

Study Registration Dates

First Submitted

December 17, 2009

First Submitted That Met QC Criteria

December 17, 2009

First Posted (ESTIMATE)

December 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 30, 2010

Last Update Submitted That Met QC Criteria

March 29, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 176-25/kmo

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fatigue

Clinical Trials on Cognitive behavioural therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe