Study of Exercise to Manage Distress During Breast Screening

NCT ID: NCT02468050

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-02-28

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.

Conditions

Breast Cancer; Anxiety; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Self Management

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.

Group Type: EXPERIMENTAL

Moderate intensity exercise training

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Exercise

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

Group Type: EXPERIMENTAL

Moderate intensity exercise training

Intervention Type: BEHAVIORAL

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.

Prospective Cohort Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Exercise; Treatment Group 1; Self Management; Self Regulation; Adherence; Treatment Group 2

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Western Ontario, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muriel Brackstone, MD PhD FRCSC

Role: STUDY_DIRECTOR

London Regional Cancer Program

Anita G Cramp, PhD

Role: STUDY_DIRECTOR

Western University

Amy Kossert, MHK

Role: STUDY_DIRECTOR

Western University

Harry Prapavessis, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

Exercise and Health Psychology Laboratory, Western University

London, Ontario, Canada

Countries

Canada

Other Identifiers

17796

Identifier Type: -

Identifier Source: org_study_id