Clinical trial NCT02468050: Study of Exercise to Manage Distress During Breast Screening
Official title: Effectiveness of Exercise Training and Self Management in the Attenuation of Anxiety and Depressive Symptoms Following Breast Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Anxiety
Depression
Keywords: Anxiety
Depression
Exercise
Breast Cancer
Biopsy
Screening
Diagnosis
Lead sponsor: University of Western Ontario, Canada
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Symptoms of anxiety will be assessed using patient reported anxiety inventory
timeFrame: Change in baseline (within 1 week of breast biopsy) at Week 3 and at Week 6
Secondary outcomes:
measure: Symptoms of subclinical depression will be assessed using a patient reported inventory
timeFrame: Within 1 week of breast biopsy, Week 3, Week 6
measure: Exercise behaviour will be assessed using a patient reported inventory
timeFrame: Within 1 week of breast biopsy, Week 3, Week 6
measure: Body composition: Dual X-Ray Absorptiometry scan (GE Lunar iDXA)
timeFrame: Baseline (within 1 week of breast biopsy), Week 6
measure: Self Efficacy: patient reported inventory assessing efficacy for self management of exercise
timeFrame: 1 week post breast biopsy, Week 3, Week 6
measure: Optimism: patient reported inventory assessing dispositional optimism
timeFrame: Baseline (within 1 week of core breast biopsy)
measure: Symptoms of dispositional anxiety will be assessed using patient reported anxiety inventory
timeFrame: Within 1 week of breast biopsy
Other outcomes:
Locations:
city: London
country: Canada
facility: Exercise and Health Psychology Laboratory, Western University
state: Ontario
Study officials:
affiliation: London Regional Cancer Program
name: Muriel Brackstone, MD PhD FRCSC
role: STUDY_DIRECTOR
affiliation: Western University
name: Anita G Cramp, PhD
role: STUDY_DIRECTOR
affiliation: Western University
name: Amy Kossert, MHK
role: STUDY_DIRECTOR
affiliation: Western University
name: Harry Prapavessis, PhD
role: PRINCIPAL_INVESTIGATOR
References: