Fatigue and Cancer Treatment(FACT)- an Exercise Intervention - Full Text View

Sponsored by:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00181129

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

MedlinePlus related topics: Cancer Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Placebo Control, Parallel Assignment
Official Title:	Mitigating Cancer Treatment-Related Fatigue by Exercise

Further study details as provided by Johns Hopkins University:

Estimated Enrollment:	140
Study Start Date:	September 2002

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:	NINR:RO1NRO4991
Study First Received:	September 12, 2005
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00181129
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

Fatigue
Cancer treatment

Study placed in the following topic categories:

Signs and Symptoms
Fatigue

ClinicalTrials.gov processed this record on January 16, 2009