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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01113554
First received: April 28, 2010
Last updated: January 28, 2014
Last verified: January 2014

April 28, 2010
January 28, 2014
June 2010
April 2013   (final data collection date for primary outcome measure)
  • Ability to recruit breast cancer survivors into a six-month breast cancer rehabilitation program [ Time Frame: Approximately 24 months ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Muscular strength [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Range of motion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 6 months ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Proportion of women who complete the study and the average number of weeks of participation [ Time Frame: Approximately 24 months ] [ Designated as safety issue: No ]
  • Ability to recruit breast cancer survivors into a six-month breast cancer rehabilitation program [ Designated as safety issue: No ]
  • BMI [ Time Frame: At baseline and 3 and 6 months ] [ Designated as safety issue: No ]
  • Muscular strength [ Time Frame: At baseline and 3 and 6 months ] [ Designated as safety issue: No ]
  • Range of motion [ Time Frame: At baseline and 3 and 6 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: At baseline and 3 and 6 months ] [ Designated as safety issue: No ]
  • Proportion of screened women who are eligible for the study and the proportion of eligible women who agree to participate [ Designated as safety issue: No ]
  • Proportion of women who complete the study and the average number of weeks of participation [ Designated as safety issue: No ]
  • Weight loss [ Time Frame: At baseline and 3 and 6 months ] [ Designated as safety issue: No ]
  • Six-minute walk [ Time Frame: At baseline and 3 and 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01113554 on ClinicalTrials.gov Archive Site
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Not Provided
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Breast Cancer Rehabilitation Program in Improving Quality of Life in Breast Cancer Survivors
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Other: questionnaire administration
  • Behavioral: exercise intervention
  • Procedure: quality-of-life assessment
    Other Name: quality of life assessment
  • Other: survey administration
  • Procedure: management of therapy complications
    Other Name: 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
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.
Interventions:
  • Other: questionnaire administration
  • Behavioral: exercise intervention
  • Procedure: quality-of-life assessment
  • Other: survey administration
  • Procedure: management of therapy complications
  • Procedure: psychosocial assessment and care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
April 2014
April 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01113554
CCCWFU 99309, NCI-2010-00975
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
Not Provided
Principal Investigator: Mara Vitolins Wake Forest School of Medicine
Comprehensive Cancer Center of Wake Forest University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP