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Completed

NCT Number: NCT01113554

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

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.

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Key information

Conditions

Stage I Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

Exercise Intervention

Behavioral

quality-of-life assessment

Procedure

Other names: quality of life assessment

Survey Administration

Other

management of therapy complications

Procedure

Other names: complications of therapy, management of

psychosocial assessment and care

Procedure

Other names: psychosocial assessment, psychosocial assessment/care, psychosocial care, psychosocial care/assessment, psychosocial studies, psychosocial support

Primary outcomes

  1. Ability to recruit breast cancer survivors into a six-month breast cancer rehabilitation program

    Time frame: Approximately 24 months

  2. BMI

    Time frame: 6 months

  3. Muscular strength

    Time frame: 6 months

  4. Range of motion

    Time frame: 6 months

  5. Quality of life

    Time frame: 6 months

  6. 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

  7. Proportion of women who complete the study and the average number of weeks of participation

    Time frame: Approximately 24 months

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 30, 2010
Registry last updated
Jul 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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