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

Stage IV Breast Cancer Clinical Trial

Official title:

A Pilot Study to Evaluate the Feasibility of a Breast Cancer Rehabilitation Program in Survivors of Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113554
• Other study ID #: IRB00012783
• Secondary ID: NCI-2010-00975CC
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Est. completion date: November 2012

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer
• Stage IV Breast Cancer

Intervention

Other:
• questionnaire administration

Behavioral:
• exercise intervention

Procedure:
• quality-of-life assessment

Other:
• survey administration

Procedure:
• management of therapy complications

• psychosocial assessment and care

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to recruit breast cancer survivors into a six-month breast cancer rehabilitation program		Approximately 24 months
Primary	BMI		6 months
Primary	Muscular strength		6 months
Primary	Range of motion		6 months
Primary	Quality of life		6 months
Primary	Proportion of screened women who are eligible for the study and the proportion of eligible women who agree to participate		Approximately 24 months
Primary	Proportion of women who complete the study and the average number of weeks of participation		Approximately 24 months