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
  Purpose

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.


Condition Intervention
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: survey administration
Procedure: management of therapy complications
Procedure: psychosocial assessment and care

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Feasibility of a Breast Cancer Rehabilitation Program in Survivors of Breast Cancer

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 25
Study Start Date: June 2010
Estimated Study Completion Date: April 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113554

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Mara Vitolins Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01113554     History of Changes
Other Study ID Numbers: CCCWFU 99309, NCI-2010-00975
Study First Received: April 28, 2010
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014