An Exercise Intervention for Breast Cancer Patients: Feasibility and Effectiveness (BEAT Cancer Trial; Pilot Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-08-31

Brief Summary

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"Translation" of the current "basic science" information related to physical activity into patient intervention programs is needed. This translation is critical to providing benefit to the maximum number of patients. Little is known about the determinants of physical activity among breast cancer patients undergoing hormonal therapy and few studies have attempted to evaluate an exercise behavior change program aimed to improve exercise adherence among such patients. The proposed project will evaluate use of an innovative behavioral and psychosocial intervention to increase physical activity among breast cancer patients.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

behavior change intervention

Group Type EXPERIMENTAL

Exercise Behavior Change

Intervention Type BEHAVIORAL

attend 12 supervised exercise sessions, attend 6 group sessions with psychologist, attend 3 counseling sessions with exercise specialist

2

written materials

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise Behavior Change

attend 12 supervised exercise sessions, attend 6 group sessions with psychologist, attend 3 counseling sessions with exercise specialist

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Female breast cancer patients between the ages of 18 and 70 years of age with a diagnosis of Stage I, II, or IIIA breast cancer who are currently taking aromatase inhibitors or selective estrogen receptor modulators for the next 8 months.
* English speaking
* Medical clearance for participation provided by primary care physicians
* If the patient has undergone a surgical procedure, must be at least 6 weeks post-procedure

Exclusion Criteria

* Diagnosis of dementia or organic brain syndrome
* Medical, psychological or social characteristic that would interfere with ability to fully participate in program activities and assessments (e.g., psychosis, schizophrenia, etc.)
* Contraindication to participation in a regular physical activity program.
* Metastatic or recurrent disease
* Inability to ambulate
* Engaged in \>/= 60 minutes of vigorous physical activity or \>/= 150 minutes of moderate plus vigorous physical activity per week during the past month.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No