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Fatigue and Cancer Treatment(FACT)- an Exercise Intervention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00181129
First Posted: September 16, 2005
Last Update Posted: September 30, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johns Hopkins University
  Purpose
The purpose of this randomized controlled trial is to determine the effects of a nurse-directed, home-based walking exercise program to mitigate fatigue and maintain physical functioning during adjuvant therapy for cancer. The sample will be randomized into exercise (EX) or usual care (UC) groups. The independent study variable is participation in a walking exercise program. Outcomes include: fatigue, sleep disturbance, emotional distress, physical functioning and quality of life. The effects of the walking exercise program will be evaluated using self-report questionnaires administered pre- and post-treatment, patient diaries, and symptoms assessments at defined intervals during adjuvant therapy

Condition Intervention
Cancer, Fatigue Behavioral: home based self paced walking program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Mitigating Cancer Treatment-Related Fatigue by Exercise

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Estimated Enrollment: 140
Study Start Date: September 2002
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Confirmed diagnosis of cancer (Stage 1,2,or 3),

21 years of age or older,

Free of cognitive or physical deficits that would preclude entry into study,

not currently exercising 120 min/wk or more

Exclusion Criteria:

Concurrent major health problems or disabilities that would limit participation in an exercise program.

Stage 4 cancer (metastisis)

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181129


Locations
United States, Maryland
Johns Hopkins University School of Nursing
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Victoria L Mock, DNSc Johns Hopkins University School of Nursing
  More Information

ClinicalTrials.gov Identifier: NCT00181129     History of Changes
Other Study ID Numbers: NINR:RO1NRO4991
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: September 30, 2008
Last Verified: September 2008

Keywords provided by Johns Hopkins University:
Fatigue
Cancer treatment

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms


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