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Breast Cancer Rehabilitation Program in Improving Quality of Life in Breast Cancer Survivors

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01113554
Collaborator
(none)
26
Enrollment
1
Location
1
Arm
29
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: A breast cancer rehabilitation program and exercise therapy may help improve the quality of life of breast cancer survivors.

PURPOSE: This clinical trial studies a breast cancer rehabilitation program in improving quality of life in breast cancer survivors.

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaire administration
  • Behavioral: exercise intervention
  • Procedure: quality-of-life assessment
  • Other: survey administration
  • Procedure: management of therapy complications
  • Procedure: psychosocial assessment and care
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. To estimate accrual, retention, adherence, and participation of breast cancer survivors to a breast cancer rehabilitation program.

  2. To estimate the variability of weight, six-minute walk, quality of life and other psychosocial and physical measures in women participating in the BCRP.

SECONDARY OBJECTIVES:

  1. To assess changes in the anthropometric, psychosocial, and physical outcomes over the six-month period of the BCRP.

  2. To document the types and the rates of adverse events associated with the BCRP.

OUTLINE:

Patients attend exercise therapy sessions over 1 hour 3 times a week for 6 months. Exercise therapy sessions are comprised of a 10 minute warm-up of light stretching and aerobic type exercise (walking, cycling), 30 minutes of endurance type exercise (cycle, walking), and 20 minutes of resistance training exercise.

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study to Evaluate the Feasibility of a Breast Cancer Rehabilitation Program in Survivors of Breast Cancer
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Nov 1, 2012
Actual Study Completion Date :
Nov 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I

Patients attend exercise therapy sessions over 1 hour 3 times a week for 6 months. Exercise therapy sessions are comprised of a 10 minute warm-up of light stretching and aerobic type exercise (walking, cycling), 30 minutes of endurance type exercise (cycle, walking), and 20 minutes of resistance training exercise.

Other: questionnaire administration

Behavioral: exercise intervention

Procedure: quality-of-life assessment
Other Names:
  • quality of life assessment

    • Other: survey administration

    Procedure: management of therapy complications
    Other Names:
  • complications of therapy, management of

    • Procedure: psychosocial assessment and care
    Other Names:
  • psychosocial assessment
  • psychosocial assessment/care
  • psychosocial care
  • psychosocial care/assessment
  • psychosocial studies
  • psychosocial support

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ability to recruit breast cancer survivors into a six-month breast cancer rehabilitation program [Approximately 24 months]

    2. BMI [6 months]

    3. Muscular strength [6 months]

    4. Range of motion [6 months]

    5. Quality of life [6 months]

    6. Proportion of screened women who are eligible for the study and the proportion of eligible women who agree to participate [Approximately 24 months]

    7. Proportion of women who complete the study and the average number of weeks of participation [Approximately 24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    Inclusion

    • First occurrence of breast cancer

    • BMI >= 25

    • Recently completed treatment(chemotherapy/radiation) for breast cancer (=< 8 weeks), but can be receiving adjuvant hormonal therapy

    • Willing to comply with study visits, as outlined in the protocol

    • Lives within 30 miles of study site, or willing to travel to study site if outside a 30-mile radius

    • Ability to participate in a moderate exercise program, such as freedom from any orthopedic abnormalities that would prevent participation

    • Ability to understand and the willingness to sign a written informed consent document

    Exclusion

    • Unstable angina

    • Cardiac conduction disturbances

    • Plans to move from the study area

    • Dementia that is medically documented or suspected

    • Advanced arterial disease causing ischemia of any limb

    • Physical immobility

    • Homebound for medical reasons

    • Dependent on wheelchair for mobility

    • Chronic disease which significantly reduces 4-year survival

    • Recurrent breast cancer

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University Health Sciences

    Investigators

    • Principal Investigator: Mara Vitolins, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT01113554
    Other Study ID Numbers:
    • IRB00012783
    • NCI-2010-00975
    • CCCWFU 99309
    First Posted:
    Apr 30, 2010
    Last Update Posted:
    Jul 5, 2018
    Last Verified:
    Jul 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jul 5, 2018