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Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01035203
First received: December 17, 2009
Last updated: March 29, 2010
Last verified: March 2010
History of Changes

December 17, 2009
March 29, 2010
December 2009
July 2010   (final data collection date for primary outcome measure)
Fatigue scores on the Brief Fatigue Inventory (BFI) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Fatigue [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01035203 on ClinicalTrials.gov Archive Site
  • Maximal oxygen uptake (VO2max) on a treadmill stress test. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Scores on the HADS (Hospital Anxiety and Depression Scale) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Physical performance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Mood [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
  • Fatigue
  • Mood
  • Maximal Oxygen Uptake
  • Behavioral: Exercise
    Endurance exercise 3 times weekly for 45 minutes, 4 weeks long
  • Behavioral: Cognitive behavioural therapy
    Teaching of techniques to reduce fatigue and to improve stamina
  • Active Comparator: Cognitive behavioural therapy
    Intervention: Behavioral: Cognitive behavioural therapy
  • Experimental: Exercise
    Endurance training (walking on a treadmill) 3 x weekly for 4 weeks
    Intervention: Behavioral: Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
September 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Fernando Dimeo, MD +493084452098 fernando.dimeo@charite.de
Germany
 
NCT01035203
176-25/kmo
No
Fernando Dimeo, MD, Charité Universitätsmedizin Berlin
Charite University, Berlin, Germany
Not Provided
Not Provided
Charite University, Berlin, Germany
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP