Physical Activity Levels and Functional Improvement in Breast Cancer Survivors (CanEX)

Do Physical Activity Levels Predict Functional Improvements Following a Structured Exercise Program for Women Living With Breast Cancer?

The main objective of our project is to describe what characteristics (e.g., age, current physical activity level) women present when starting the exercise program are potentially associated with an improvement in functional abilities measured with different tests such as the distance you can cover while walking for six minutes.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Exercise Program

Detailed Description

The main research objective is to investigate the relationship between baseline physical activity and improvement in physical function, quantified using changes in 6-minute walk test (6MWT) results over the course of the 12-week program. An association is hypothesized to exist between the two variables even when adjusted for weeks into treatment. The goal of the 6MWT is to cover as much distance as possible in six minutes, using as many breaks s necessary. The test is often performed using a 20-meter hallway but requires no specific equipment. A recent study reported that the result of the 6MWT could be used as a measure of the major components of global health in women with breast cancer, making its use in our research especially relevant. Aside from physical functions, baseline characteristics will also be used to determine what characteristics, if any, are associated with health and psychosocial outcomes such as quality of life, social connectedness/support, and mental well-being. The data collected is certain to fill a gap in the literature, and will therefore be likely published in an important journal in the field.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • New Brunswick
    • Fredericton, New Brunswick, Canada
      • Recruiting
      • University of New Brunswick
      • Contact: Danielle Bouchard; Phone Number: 5064433908; Email: dboucha1@unb.ca
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada
      • Recruiting
      • Memorial University of Newfoundland
      • Contact: Erin McGowan; Phone Number: 7098647269; Email: emcgowan@mun.ca
  • Prince Edward Island
    • Charlottetown, Prince Edward Island, Canada
      • Recruiting
      • University of Prince Edward Island
      • Contact: Travis Saunders; Phone Number: 9025660641; Email: trsaunders@upei.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Have received a diagnosis of breast cancer in your lifetime
• 19 years of age and older
• Cleared by medical team to participate in the study
• Have the intention to exercise at the facility for the duration of the study

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Participant; Participants will answer a series of questionnaires, wear a physical activity tracker (pedometer) and do functional tests (six minute walk test, chair stand test, balance, back scratch, sit and reach, leg strength and hand strength) pre and post.	Other: Exercise Program; Participants will exercise twice a week for twelve weeks total.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking speed	6-minute walk test (meters walked)	Pre and post (after 12 weeks)
Balance	One leg stand test (seconds)	Pre and post (after 12 weeks)
Strength, Hand grip	Amount of force that can be exerted during grip squeeze (kg)	Pre and post (after 12 weeks)
Strength, Chair stand test	Chair stand test, number of chair stand in 30 seconds	Pre and post (after 12 weeks)
Flexibility, back scratch test	Back scratch test (cm)	Pre and post (after 12 weeks)
Flexibility, sit and reach	Sit and reach test	Pre and post (after 12 weeks)
Physical Activity Level	Pedometer to determine minutes in moderate-vigorous physical activity and steps per day	Pre and post (after 12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance	Amount of exercise sessions attended during the 12-week program	Pre and post (after 12 weeks)
Weight	Weight of individual (kg)	Pre and post (after 12 weeks)
Height	Height of individual (cm)	Pre and post (after 12 weeks)
Resting Blood Pressure	Systolic and diastolic blood pressure (mmHg)	Pre and post (after 12 weeks)
Resting Heart Rate	Resting heart rate (beats per minute)	Pre and post (after 12 weeks)
Body-mass Index	Measure of body fat based on height and weight (kg/m^2)	Pre and post (after 12 weeks)
Waist Circumference	Measurement around the waist (cm)	Pre and post (after 12 weeks)
FANTASTIC Lifestyle Checklist	Meaningful improvement above day-to-day variability on the 6MWT	Pre and post (after 12 weeks)
Functional Assessment of Cancer Therapy General (FACT - G)	27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being	Pre and post (after 12 weeks)
Functional Assessment of Cancer Therapy Fatigue (FACT - F)	40-item measure that assesses self-reported fatigue and its impact upon daily activities and function	Pre and post (after 12 weeks)
Depression Anxiety Stress Scales (DASS)	42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress.	Pre and post (after 12 weeks)
Pittsburgh Sleep Quality Index (PSQI)	A self-report questionnaire that assesses sleep quality over a 1-month time interval	Pre and post (after 12 weeks)
Godin-Shephard Leisure-Time Physical Activity Questionnaire	Questionnaire used to identify self-reported leisure-time physical activity	Pre and post (after 12 weeks)
Age	Age (years)	Pre and post (after 12 weeks)

Collaborators and Investigators

• Sponsor: University of New Brunswick
• Collaborators: Quebec Breast Cancer Foundation; Ultramar
• Investigators: Principal Investigator: Danielle Bouchard, University of New Brunswick

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 11, 2018
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): April 1, 2021

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (ACTUAL): December 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: University Brunswick

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No