Study of Exercise to Manage Distress During Breast Screening

Phase 2

Completed

• Conditions: Breast Cancer; Anxiety; Depression
• Interventions: Behavioral: Moderate intensity exercise training; Behavioral: Self Management of exercise

• Registration Number: NCT02468050
• Lead Sponsor: University of Western Ontario, Canada

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-06-25
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-06
• Study First Submitted QC: 2015-06-05
• Last Update Submitted: 2015-06-05
• Study First Posted: 2015-06-10
• Last Update Posted: 2015-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Self Management	Self Management of exercise	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.
Self Management	Moderate intensity exercise training	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.
Exercise	Moderate intensity exercise training	Personalized 6 week moderate intensity (50 - 75% of heart rate reserve) facility and home based exercise program including cardiovascular and muscular conditioning.

Primary Outcome Measures

Name	Time	Method
Symptoms of anxiety will be assessed using patient reported anxiety inventory	Change in baseline (within 1 week of breast biopsy) at Week 3 and at Week 6	Spielberger State-Trait Anxiety Inventory - State Form (STAI; Spielberger, Gorsuch, \& Lushene, 1970).

Secondary Outcome Measures

Name	Time	Method
Exercise behaviour will be assessed using a patient reported inventory	Within 1 week of breast biopsy, Week 3, Week 6	Leisure Time Exercise Questionnaire (Godin \& Shephard, 1985)
Symptoms of dispositional anxiety will be assessed using patient reported anxiety inventory	Within 1 week of breast biopsy	STAI - Trait Form
Self Efficacy: patient reported inventory assessing efficacy for self management of exercise	1 week post breast biopsy, Week 3, Week 6
Optimism: patient reported inventory assessing dispositional optimism	Baseline (within 1 week of core breast biopsy)	Life Orientation Test-Revised (LOT-R; Scheier, Carver, \& Bridges, 1994).
Symptoms of subclinical depression will be assessed using a patient reported inventory	Within 1 week of breast biopsy, Week 3, Week 6	Centre for Epidemiologic Studies-Depression Scale (CES-D; Radloff, 1977).
Body composition: Dual X-Ray Absorptiometry scan (GE Lunar iDXA)	Baseline (within 1 week of breast biopsy), Week 6

Trial Locations

Locations (1)

Exercise and Health Psychology Laboratory, Western University; 🇨🇦 London, Ontario, Canada