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.

Study Overview

• Status: Completed
• Conditions: Stage I Breast Cancer; Stage IV Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
• Intervention / Treatment: Other: survey administration; Other: questionnaire administration; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment; Procedure: management of therapy complications; Behavioral: exercise intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: survey administration; Other: questionnaire administration; Procedure: psychosocial assessment and care; Other Names: psychosocial assessment; psychosocial assessment/care; psychosocial care; psychosocial care/assessment; psychosocial studies; psychosocial support; Procedure: quality-of-life assessment; Other Names: quality of life assessment; Procedure: management of therapy complications; Other Names: complications of therapy, management of; Behavioral: exercise intervention

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: April 28, 2010
• First Submitted That Met QC Criteria: April 29, 2010
• First Posted (Estimate): April 30, 2010

Study Record Updates

• Last Update Posted (Actual): July 5, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IRB00012783; NCI-2010-00975; CCCWFU 99309 (Other Identifier: Wake Forest University Health Sciences)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No