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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01113554
First Posted: April 30, 2010
Last Update Posted: November 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  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: Intervention Model: Single Group Assignment
Masking: None (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 Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Ability to recruit breast cancer survivors into a six-month breast cancer rehabilitation program [ Time Frame: Approximately 24 months ]
  • BMI [ Time Frame: 6 months ]
  • Muscular strength [ Time Frame: 6 months ]
  • Range of motion [ Time Frame: 6 months ]
  • Quality of life [ Time Frame: 6 months ]
  • 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 ]
  • Proportion of women who complete the study and the average number of weeks of participation [ Time Frame: Approximately 24 months ]

Enrollment: 26
Study Start Date: June 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113554


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

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01113554     History of Changes
Other Study ID Numbers: CCCWFU 99309
NCI-2010-00975
First Submitted: April 28, 2010
First Posted: April 30, 2010
Last Update Posted: November 2, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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