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Study of Exercise to Manage Distress During Breast Screening

Sponsor
University of Western Ontario, Canada (Other)
Overall Status
Completed
CT.gov ID
NCT02468050
Collaborator
(none)
7
Enrollment
1
Location
3
Arms
24
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Moderate intensity exercise training
  • Behavioral: Self Management of exercise
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effectiveness of Exercise Training and Self Management in the Attenuation of Anxiety and Depressive Symptoms Following Breast Biopsy
Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Feb 1, 2014

Arms and Interventions

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:
  • Self Management
  • Self Regulation
  • Adherence
  • Treatment Group 2

    		•
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    2. 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)

    3. Body composition: Dual X-Ray Absorptiometry scan (GE Lunar iDXA) [Baseline (within 1 week of breast biopsy), Week 6]

    4. Self Efficacy: patient reported inventory assessing efficacy for self management of exercise [1 week post breast biopsy, Week 3, Week 6]

    5. 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).

    6. Symptoms of dispositional anxiety will be assessed using patient reported anxiety inventory [Within 1 week of breast biopsy]

      STAI - Trait Form

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 69 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Exercise and Health Psychology Laboratory, Western University London Ontario Canada N6A 3K7

    Sponsors and Collaborators

    • University of Western Ontario, Canada

    Investigators

    • 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
    • Principal Investigator: Harry Prapavessis, PhD, Western University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Western Ontario, Canada
    ClinicalTrials.gov Identifier:
    NCT02468050
    Other Study ID Numbers:
    • 17796
    First Posted:
    Jun 10, 2015
    Last Update Posted:
    Jun 10, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by University of Western Ontario, Canada
    Anxiety
    Depression
    Exercise
    Breast Cancer
    Biopsy
    Screening
    Diagnosis
    Additional relevant MeSH terms:
    Depression
    Anxiety Disorders

    Study Results

    No Results Posted as of Jun 10, 2015