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Clinical Trials/NCT02468050
NCT02468050
Completed
Phase 2

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

University of Western Ontario, Canada1 site in 1 country7 target enrollmentFebruary 2012

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University of Western Ontario, Canada
Enrollment
7
Locations
1
Primary Endpoint
Symptoms of anxiety will be assessed using patient reported anxiety inventory
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
February 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Sponsor
University of Western Ontario, Canada
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

  • Symptoms of dispositional anxiety will be assessed using patient reported anxiety inventory(Within 1 week of breast biopsy)
  • Exercise behaviour will be assessed using a patient reported inventory(Within 1 week of breast biopsy, Week 3, Week 6)
  • Self Efficacy: patient reported inventory assessing efficacy for self management of exercise(1 week post breast biopsy, Week 3, Week 6)
  • Optimism: patient reported inventory assessing dispositional optimism(Baseline (within 1 week of core breast biopsy))
  • Symptoms of subclinical depression will be assessed using a patient reported inventory(Within 1 week of breast biopsy, Week 3, Week 6)
  • Body composition: Dual X-Ray Absorptiometry scan (GE Lunar iDXA)(Baseline (within 1 week of breast biopsy), Week 6)

Study Sites (1)

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