Study of Exercise to Manage Distress During Breast Screening

Study Overview
=================
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.

Official Title
-----------------
Effectiveness of Exercise Training and Self Management in the Attenuation of Anxiety and Depressive Symptoms Following Breast Biopsy

Conditions
-----------------
Breast Cancer, Anxiety, Depression

Intervention / Treatment
-----------------
* Behavioral: Moderate intensity exercise training
* Behavioral: Self Management of exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self Management<br>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. | Behavioral: Moderate intensity exercise training<br>* 6 weeks of moderate intensity exercise training (50 - 75% of heart rate reserve). Sessions are facility and home based and include cardiovascular warm-up, cardiovascular training, muscular conditioning, and flexibility exercises.<br>* Other names: Treatment Group 1;Behavioral: Self Management of exercise<br>* In addition to the 6 week exercise program (refer to Exercise Treatment Group), participants randomly assigned to the Self Management Group will learn strategies for the self management of exercise.<br>* Other names: Treatment Group 2;|
| Experimental: Exercise<br>Personalized 6 week moderate intensity (50 - 75% of heart rate reserve) facility and home based exercise program including cardiovascular and muscular conditioning. | Behavioral: Moderate intensity exercise training<br>* 6 weeks of moderate intensity exercise training (50 - 75% of heart rate reserve). Sessions are facility and home based and include cardiovascular warm-up, cardiovascular training, muscular conditioning, and flexibility exercises.<br>* Other names: Treatment Group 1;|
| No Intervention: Prospective Cohort Control<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anxiety, Depression, Exercise, Breast Cancer, Biopsy, Screening, Diagnosis