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Study of Exercise to Manage Distress During Breast Screening

Primary Purpose

Breast Cancer, Anxiety, Depression

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Moderate intensity exercise training
Self Management of exercise
Sponsored by
University of Western Ontario, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Anxiety, Depression, Exercise, Breast Cancer, Biopsy, Screening, Diagnosis

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Exercise and Health Psychology Laboratory, Western University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Self Management

Exercise

Prospective Cohort Control

Arm Description

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.

Personalized 6 week moderate intensity (50 - 75% of heart rate reserve) facility and home based exercise program including cardiovascular and muscular conditioning.

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.

Outcomes

Primary Outcome Measures

Symptoms of anxiety will be assessed using patient reported anxiety inventory
Spielberger State-Trait Anxiety Inventory - State Form (STAI; Spielberger, Gorsuch, & Lushene, 1970).

Secondary Outcome Measures

Symptoms of subclinical depression will be assessed using a patient reported inventory
Centre for Epidemiologic Studies-Depression Scale (CES-D; Radloff, 1977).
Exercise behaviour will be assessed using a patient reported inventory
Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
Body composition: Dual X-Ray Absorptiometry scan (GE Lunar iDXA)
Self Efficacy: patient reported inventory assessing efficacy for self management of exercise
Optimism: patient reported inventory assessing dispositional optimism
Life Orientation Test-Revised (LOT-R; Scheier, Carver, & Bridges, 1994).
Symptoms of dispositional anxiety will be assessed using patient reported anxiety inventory
STAI - Trait Form

Full Information

First Posted
June 25, 2012
Last Updated
June 5, 2015
Sponsor
University of Western Ontario, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02468050
Brief Title
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

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Western Ontario, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Anxiety, Depression
Keywords
Anxiety, Depression, Exercise, Breast Cancer, Biopsy, Screening, Diagnosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self Management
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Personalized 6 week moderate intensity (50 - 75% of heart rate reserve) facility and home based exercise program including cardiovascular and muscular conditioning.
Arm Title
Prospective Cohort Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Moderate intensity exercise training
Other Intervention Name(s)
Exercise, Treatment Group 1
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self Management of exercise
Other Intervention Name(s)
Self Management, Self Regulation, Adherence, Treatment Group 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptoms of anxiety will be assessed using patient reported anxiety inventory
Description
Spielberger State-Trait Anxiety Inventory - State Form (STAI; Spielberger, Gorsuch, & Lushene, 1970).
Time Frame
Change in baseline (within 1 week of breast biopsy) at Week 3 and at Week 6
Secondary Outcome Measure Information:
Title
Symptoms of subclinical depression will be assessed using a patient reported inventory
Description
Centre for Epidemiologic Studies-Depression Scale (CES-D; Radloff, 1977).
Time Frame
Within 1 week of breast biopsy, Week 3, Week 6
Title
Exercise behaviour will be assessed using a patient reported inventory
Description
Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
Time Frame
Within 1 week of breast biopsy, Week 3, Week 6
Title
Body composition: Dual X-Ray Absorptiometry scan (GE Lunar iDXA)
Time Frame
Baseline (within 1 week of breast biopsy), Week 6
Title
Self Efficacy: patient reported inventory assessing efficacy for self management of exercise
Time Frame
1 week post breast biopsy, Week 3, Week 6
Title
Optimism: patient reported inventory assessing dispositional optimism
Description
Life Orientation Test-Revised (LOT-R; Scheier, Carver, & Bridges, 1994).
Time Frame
Baseline (within 1 week of core breast biopsy)
Title
Symptoms of dispositional anxiety will be assessed using patient reported anxiety inventory
Description
STAI - Trait Form
Time Frame
Within 1 week of breast biopsy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muriel Brackstone, MD PhD FRCSC
Organizational Affiliation
London Regional Cancer Program
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anita G Cramp, PhD
Organizational Affiliation
Western University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amy Kossert, MHK
Organizational Affiliation
Western University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Harry Prapavessis, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise and Health Psychology Laboratory, Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada

12. IPD Sharing Statement

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Study of Exercise to Manage Distress During Breast Screening

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