Clinical trial NCT01113554: Breast Cancer Rehabilitation Program in Improving Quality of Life in Breast Cancer Survivors
Official title: A Pilot Study to Evaluate the Feasibility of a Breast Cancer Rehabilitation Program in Survivors of Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stage I Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2010-04-30
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ability to recruit breast cancer survivors into a six-month breast cancer rehabilitation program
timeFrame: Approximately 24 months
measure: BMI
timeFrame: 6 months
measure: Muscular strength
timeFrame: 6 months
measure: Range of motion
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Proportion of screened women who are eligible for the study and the proportion of eligible women who agree to participate
timeFrame: Approximately 24 months
measure: Proportion of women who complete the study and the average number of weeks of participation
timeFrame: Approximately 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Mara Vitolins
role: PRINCIPAL_INVESTIGATOR
References: