Study of Exercise to Manage Distress During Breast Screening

NCT02468050 | Completed Phase 2

• 1 other identifier: 17796
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Anxiety; Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Symptoms of anxiety will be assessed using patient reported anxiety inventory

  Spielberger State-Trait Anxiety Inventory - State Form (STAI; Spielberger, Gorsuch, \& Lushene, 1970).

  Change in baseline (within 1 week of breast biopsy) at Week 3 and at Week 6

Secondary Outcomes (6)

• Symptoms of subclinical depression will be assessed using a patient reported inventory

  Within 1 week of breast biopsy, Week 3, Week 6

• Exercise behaviour 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

• 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)

Study Arms (3)

Self Management

EXPERIMENTAL

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.

Behavioral: Moderate intensity exercise training; Behavioral: Self Management of exercise

Exercise

EXPERIMENTAL

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

Behavioral: Moderate intensity exercise training

Prospective Cohort Control

NO INTERVENTION

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.

Interventions

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.

Also known as: Exercise, Treatment Group 1

Exercise; Self Management

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.

Also known as: Self Management, Self Regulation, Adherence, Treatment Group 2

Self Management

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing breast biopsy at St. Joseph's Health Care, London Ontario
• minimum BI-RADS 4a
• physically inactive

You may not qualify if:

• meeting Health Canada Guidelines for Physical Activity for past 6 months
• medical contraindications to exercise
• unable to participate in moderate intensity exercise program

Sponsors & Collaborators

• University of Western Ontario, Canada: lead

Study Sites (1)

Exercise and Health Psychology Laboratory, Western University

London, Ontario, N6A 3K7, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Anxiety Disorders; Depression; Motor Activity; Disease

Interventions

Exercise; Self-Management; Professional Autonomy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Muriel Brackstone, MD PhD FRCSC

  London Regional Cancer Program

  STUDY DIRECTOR

• Anita G Cramp, PhD

  Western University

  STUDY DIRECTOR

• Amy Kossert, MHK

  Western University

  STUDY DIRECTOR

• Harry Prapavessis, PhD

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: June 10, 2015
• Study Start: February 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 10, 2015

Record last verified: 2015-06

Locations

CA (1)