Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue

NCT ID: NCT01035203

Last Updated: 2010-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fatigue Mood Maximal Oxygen Uptake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Cognitive behavioural therapy

Group Type ACTIVE_COMPARATOR

Cognitive behavioural therapy

Intervention Type BEHAVIORAL

Teaching of techniques to reduce fatigue and to improve stamina

Exercise

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

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Endurance exercise 3 times weekly for 45 minutes, 4 weeks long

Interventions

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Exercise

Endurance exercise 3 times weekly for 45 minutes, 4 weeks long

Intervention Type BEHAVIORAL

Cognitive behavioural therapy

Teaching of techniques to reduce fatigue and to improve stamina

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Charité Universitätsmedizin Berlin

Locations

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Department of Sports Medicine

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Fernando Dimeo, MD

Role: CONTACT

Phone: +493084452098

Email: [email protected]

Facility Contacts

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Fernando Dimeo, MD

Role: primary

Susanne Effenberger

Role: backup

Other Identifiers

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176-25/kmo

Identifier Type: -

Identifier Source: org_study_id