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Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue

Primary Purpose

Fatigue, Mood, Maximal Oxygen Uptake

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Exercise
Cognitive behavioural therapy
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Sports MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cognitive behavioural therapy

Exercise

Arm Description

Endurance training (walking on a treadmill) 3 x weekly for 4 weeks

Outcomes

Primary Outcome Measures

Fatigue scores on the Brief Fatigue Inventory (BFI)

Secondary Outcome Measures

Maximal oxygen uptake (VO2max) on a treadmill stress test.
Scores on the HADS (Hospital Anxiety and Depression Scale)

Full Information

First Posted
December 17, 2009
Last Updated
March 29, 2010
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01035203
Brief Title
Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue
Official Title
Effects of a Brief Endurance Exercise Program and of a Cognitive Behavioural Therapy on Patients With Cancer-related Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Mood, Maximal Oxygen Uptake

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavioural therapy
Arm Type
Active Comparator
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Endurance training (walking on a treadmill) 3 x weekly for 4 weeks
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Endurance exercise 3 times weekly for 45 minutes, 4 weeks long
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioural therapy
Intervention Description
Teaching of techniques to reduce fatigue and to improve stamina
Primary Outcome Measure Information:
Title
Fatigue scores on the Brief Fatigue Inventory (BFI)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Maximal oxygen uptake (VO2max) on a treadmill stress test.
Time Frame
4 weeks
Title
Scores on the HADS (Hospital Anxiety and Depression Scale)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando Dimeo, MD
Phone
+493084452098
Email
fernando.dimeo@charite.de
Facility Information:
Facility Name
Department of Sports Medicine
City
Berlin
ZIP/Postal Code
14167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Dimeo, MD
Phone
+493084452098
Email
fernando.dimeo@charite.de
First Name & Middle Initial & Last Name & Degree
Susanne Effenberger
Phone
+493084454834
Email
susanne.effenberger@charite.de

12. IPD Sharing Statement

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Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue

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