Study of Exercise to Manage Distress During Breast Screening

June 5, 2015 updated by: University of Western Ontario, Canada

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 3K7
        • Exercise and Health Psychology Laboratory, Western University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • Exercise
  • Treatment Group 1
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.
Other Names:
  • Adherence
  • Treatment Group 2
  • Self Management
  • Self Regulation
Experimental: Exercise
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
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.
Other Names:
  • Exercise
  • Treatment Group 1
No Intervention: 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.

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
Time Frame: 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).
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
Time Frame: Within 1 week of breast biopsy, Week 3, Week 6
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
Time Frame: Within 1 week of breast biopsy, Week 3, Week 6
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)
Time Frame: Baseline (within 1 week of breast biopsy), Week 6
Baseline (within 1 week of breast biopsy), Week 6
Self Efficacy: patient reported inventory assessing efficacy for self management of exercise
Time Frame: 1 week post breast biopsy, Week 3, Week 6
1 week post breast biopsy, Week 3, Week 6
Optimism: patient reported inventory assessing dispositional optimism
Time Frame: Baseline (within 1 week of core breast biopsy)
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
Time Frame: Within 1 week of breast biopsy
STAI - Trait Form
Within 1 week of breast biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Western Ontario, Canada

Investigators

  • Principal Investigator: Harry Prapavessis, PhD, Western University
  • Study Director: Muriel Brackstone, MD PhD FRCSC, London Regional Cancer Program
  • Study Director: Anita G Cramp, PhD, Western University
  • Study Director: Amy Kossert, MHK, Western University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

June 25, 2012

First Submitted That Met QC Criteria

June 5, 2015

First Posted (Estimate)

June 10, 2015

Study Record Updates

Last Update Posted (Estimate)

June 10, 2015

Last Update Submitted That Met QC Criteria

June 5, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17796

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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