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Study of Exercise to Manage Distress During Breast Screening

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02468050
Enrollment
7
Registered
2015-06-10
Start date
2012-02-29
Completion date
2014-02-28
Last updated
2015-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Anxiety, Depression

Keywords

Anxiety, Depression, Exercise, Breast Cancer, Biopsy, Screening, Diagnosis

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.

Interventions

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.

BEHAVIORALSelf 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.

Sponsors

University of Western Ontario, Canada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 69 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Symptoms of anxiety will be assessed using patient reported anxiety inventoryChange in baseline (within 1 week of breast biopsy) at Week 3 and at Week 6Spielberger State-Trait Anxiety Inventory - State Form (STAI; Spielberger, Gorsuch, & Lushene, 1970).

Secondary

MeasureTime frameDescription
Exercise behaviour will be assessed using a patient reported inventoryWithin 1 week of breast biopsy, Week 3, Week 6Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
Body composition: Dual X-Ray Absorptiometry scan (GE Lunar iDXA)Baseline (within 1 week of breast biopsy), Week 6
Symptoms of subclinical depression will be assessed using a patient reported inventoryWithin 1 week of breast biopsy, Week 3, Week 6Centre for Epidemiologic Studies-Depression Scale (CES-D; Radloff, 1977).
Optimism: patient reported inventory assessing dispositional optimismBaseline (within 1 week of core breast biopsy)Life Orientation Test-Revised (LOT-R; Scheier, Carver, & Bridges, 1994).
Symptoms of dispositional anxiety will be assessed using patient reported anxiety inventoryWithin 1 week of breast biopsySTAI - Trait Form
Self Efficacy: patient reported inventory assessing efficacy for self management of exercise1 week post breast biopsy, Week 3, Week 6

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026