Study of Exercise to Manage Distress During Breast Screening

University of Western Ontario, Canada

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Depression; Anxiety

Treatments: Behavioral: Self Management of exercise; Behavioral: Moderate intensity exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT02468050

17796

Details and patient eligibility

About

The breast cancer screening and diagnostic period is associated with heightened symptoms of anxiety and depression. Physical exercise has been found to effectively decrease these symptoms in healthy and diseased populations. This study aims to determine if a pre treatment exercise intervention can minimize symptoms of anxiety and depression in women undergoing screening for breast cancer.

Full description

The breast cancer diagnostic process is associated with anxiety and depression. Physical exercise has emerged as an attractive non-pharmacologic approach to mitigating the psychological and physical sequelae of breast cancer and its treatments, however pre treatment interventions are not integrated into current practice. This study aims to determine the effectiveness and feasibility of a pre treatment exercise intervention in attenuating levels of anxiety and depression following breast biopsy and throughout the diagnostic period.

Enrollment: 7 patients

Sex: Female

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• undergoing breast biopsy at St. Joseph's Health Care, London Ontario
• minimum BI-RADS 4a
• physically inactive

Exclusion criteria

• meeting Health Canada Guidelines for Physical Activity for past 6 months
• medical contraindications to exercise
• unable to participate in moderate intensity exercise program

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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7 participants in 3 patient groups

Self Management

Experimental group

Description:

In addition to the weekly supervised exercise session, participants in this arm will view an instructional video. The video will deliver theory driven training of cognitive behavioural strategies for self management of exercise. It is expected that this will improve adherence to the exercise program.

Treatment:

Behavioral: Moderate intensity exercise training

Behavioral: Self Management of exercise

Exercise

Experimental group

Description:

Personalized 6 week moderate intensity (50 - 75% of heart rate reserve) facility and home based exercise program including cardiovascular and muscular conditioning.

Treatment:

Behavioral: Moderate intensity exercise training

Prospective Cohort Control

No Intervention group

Description:

Eligible, consented participants who are unable to attend the weekly exercise sessions will serve as a cohort control group. Participants will be asked to complete patient reported measures of anxiety, depression, and exercise behaviour within 3 days of biopsy, and 6 weeks post biopsy.