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

Brief Summary

Official Title: “A Pilot Study to Evaluate the Feasibility of a Breast Cancer Rehabilitation Program in Survivors of Breast Cancer”

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.

  • Study Type: Interventional
  • Study Design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: April 2013

Detailed Clinical Trial Description

PRIMARY OBJECTIVES:

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

II. 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:

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

II. 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.

Interventions Used in this Clinical Trial

  • Other: questionnaire administration
  • Behavioral: exercise intervention
  • Procedure: quality-of-life assessment
  • Other: survey administration
  • Procedure: management of therapy complications
  • Procedure: psychosocial assessment and care

Arms, Groups and Cohorts in this Clinical Trial

  • 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • Ability to recruit breast cancer survivors into a six-month breast cancer rehabilitation program
    • Time Frame: Approximately 24 months
      Safety Issue?: No
  • BMI
    • Time Frame: 6 months
      Safety Issue?: No
  • Muscular strength
    • Time Frame: 6 months
      Safety Issue?: No
  • Range of motion
    • Time Frame: 6 months
      Safety Issue?: No
  • Quality of life
    • Time Frame: 6 months
      Safety Issue?: No
  • Proportion of screened women who are eligible for the study and the proportion of eligible women who agree to participate
    • Time Frame: Approximately 24 months
      Safety Issue?: No
  • Proportion of women who complete the study and the average number of weeks of participation
    • Time Frame: Approximately 24 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Comprehensive Cancer Center of Wake Forest University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mara Vitolins, Principal Investigator, Wake Forest School of Medicine

Source

Clinical Trials content is provided directly by the US National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of information about a specific clinical trial contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01113554