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Study of Exercise to Manage Distress During Breast Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02468050
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
University of Western Ontario, Canada

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
Breast Cancer Anxiety Depression 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.

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Study Type : Interventional  (Clinical Trial)
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 : February 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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)

  3. Body composition: Dual X-Ray Absorptiometry scan (GE Lunar iDXA) [ Time Frame: Baseline (within 1 week of breast biopsy), Week 6 ]
  4. Self Efficacy: patient reported inventory assessing efficacy for self management of exercise [ Time Frame: 1 week post breast biopsy, Week 3, Week 6 ]
  5. 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).

  6. Symptoms of dispositional anxiety will be assessed using patient reported anxiety inventory [ Time Frame: Within 1 week of breast biopsy ]
    STAI - Trait Form



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468050


Locations
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Canada, Ontario
Exercise and Health Psychology Laboratory, Western University
London, Ontario, Canada, N6A 3K7
Sponsors and Collaborators
University of Western Ontario, Canada
Investigators
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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
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Responsible Party: University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT02468050    
Other Study ID Numbers: 17796
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015
Keywords provided by University of Western Ontario, Canada:
Anxiety
Depression
Exercise
Breast Cancer
Biopsy
Screening
Diagnosis
Additional relevant MeSH terms:
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Depression
Anxiety Disorders
Behavioral Symptoms
Mental Disorders