Clincosm LogoSign in Get a demo

Fatigue and Cancer Treatment(FACT)- an Exercise Intervention

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT00181129
Collaborator
(none)
140
Enrollment
1
Location
68
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: home based self paced walking program
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Mitigating Cancer Treatment-Related Fatigue by Exercise
Actual Study Start Date :
Sep 1, 2002
Actual Primary Completion Date :
May 1, 2008
Actual Study Completion Date :
May 1, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT00181129
    Other Study ID Numbers:
    • NINR:RO1NRO4991
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    Dec 20, 2018
    Last Verified:
    Dec 1, 2018
    Keywords provided by Johns Hopkins University
    Fatigue
    Cancer treatment
    Additional relevant MeSH terms:
    Fatigue

    Study Results

    No Results Posted as of Dec 20, 2018