Study of Exercise to Manage Distress During Breast Screening

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02468050
• Other study ID #: 17796
• Status: Completed
• Phase: Phase 2
• First received: June 25, 2012
• Last updated: June 5, 2015
• Start date: February 2012
• Est. completion date: February 2014

Study information

• Verified date: June 2015
• Source: University of Western Ontario, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 69 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety
• Breast Cancer
• Depression

Intervention

Behavioral:
• Moderate intensity exercise training
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.
• Self Management of exercise
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.

Locations

Country	Name	City	State
Canada	Exercise and Health Psychology Laboratory, Western University	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Body composition: Dual X-Ray Absorptiometry scan (GE Lunar iDXA)		Baseline (within 1 week of breast biopsy), Week 6	No
Secondary	Self Efficacy: patient reported inventory assessing efficacy for self management of exercise		1 week post breast biopsy, Week 3, Week 6	No
Secondary	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)	No
Secondary	Symptoms of dispositional anxiety will be assessed using patient reported anxiety inventory	STAI - Trait Form	Within 1 week of breast biopsy	No