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Completed

NCT Number: NCT02468050

Study of Exercise to Manage Distress During Breast Screening

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.

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Key information

Conditions

Breast Cancer Anxiety Anxiety Disorders Behavior Behavioral Symptoms Breast Diseases Breast Neoplasms Depression Disease Mental Disorders Motor Activity Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Exercise and Health Psychology Laboratory, Western University

London, Ontario, N6A 3K7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderate Intensity Exercise Training

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.

Other names: Exercise, Treatment Group 1

Self Management of exercise

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.

Other names: Self Management, Self Regulation, Adherence, Treatment Group 2

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Western Ontario, Canada

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 10, 2015
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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