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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise Program
Sponsored by
University of New Brunswick
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

-

Sites / Locations

  • University of New BrunswickRecruiting
  • Memorial University of NewfoundlandRecruiting
  • University of Prince Edward IslandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participant

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Attendance
Amount of exercise sessions attended during the 12-week program
Weight
Weight of individual (kg)
Height
Height of individual (cm)
Resting Blood Pressure
Systolic and diastolic blood pressure (mmHg)
Resting Heart Rate
Resting heart rate (beats per minute)
Body-mass Index
Measure of body fat based on height and weight (kg/m^2)
Waist Circumference
Measurement around the waist (cm)
FANTASTIC Lifestyle Checklist
Meaningful improvement above day-to-day variability on the 6MWT
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
Functional Assessment of Cancer Therapy Fatigue (FACT - F)
40-item measure that assesses self-reported fatigue and its impact upon daily activities and function
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.
Pittsburgh Sleep Quality Index (PSQI)
A self-report questionnaire that assesses sleep quality over a 1-month time interval
Godin-Shephard Leisure-Time Physical Activity Questionnaire
Questionnaire used to identify self-reported leisure-time physical activity
Age
Age (years)

Full Information

First Posted
December 1, 2020
Last Updated
February 17, 2021
Sponsor
University of New Brunswick
Collaborators
Ultramar, Quebec Breast Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04679090
Brief Title
Physical Activity Levels and Functional Improvement in Breast Cancer Survivors
Acronym
CanEX
Official Title
Do Physical Activity Levels Predict Functional Improvements Following a Structured Exercise Program for Women Living With Breast Cancer?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Brunswick
Collaborators
Ultramar, Quebec Breast Cancer Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participant
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise Program
Intervention Description
Participants will exercise twice a week for twelve weeks total.
Primary Outcome Measure Information:
Title
Walking speed
Description
6-minute walk test (meters walked)
Time Frame
Pre and post (after 12 weeks)
Title
Balance
Description
One leg stand test (seconds)
Time Frame
Pre and post (after 12 weeks)
Title
Strength, Hand grip
Description
Amount of force that can be exerted during grip squeeze (kg)
Time Frame
Pre and post (after 12 weeks)
Title
Strength, Chair stand test
Description
Chair stand test, number of chair stand in 30 seconds
Time Frame
Pre and post (after 12 weeks)
Title
Flexibility, back scratch test
Description
Back scratch test (cm)
Time Frame
Pre and post (after 12 weeks)
Title
Flexibility, sit and reach
Description
Sit and reach test
Time Frame
Pre and post (after 12 weeks)
Title
Physical Activity Level
Description
Pedometer to determine minutes in moderate-vigorous physical activity and steps per day
Time Frame
Pre and post (after 12 weeks)
Secondary Outcome Measure Information:
Title
Attendance
Description
Amount of exercise sessions attended during the 12-week program
Time Frame
Pre and post (after 12 weeks)
Title
Weight
Description
Weight of individual (kg)
Time Frame
Pre and post (after 12 weeks)
Title
Height
Description
Height of individual (cm)
Time Frame
Pre and post (after 12 weeks)
Title
Resting Blood Pressure
Description
Systolic and diastolic blood pressure (mmHg)
Time Frame
Pre and post (after 12 weeks)
Title
Resting Heart Rate
Description
Resting heart rate (beats per minute)
Time Frame
Pre and post (after 12 weeks)
Title
Body-mass Index
Description
Measure of body fat based on height and weight (kg/m^2)
Time Frame
Pre and post (after 12 weeks)
Title
Waist Circumference
Description
Measurement around the waist (cm)
Time Frame
Pre and post (after 12 weeks)
Title
FANTASTIC Lifestyle Checklist
Description
Meaningful improvement above day-to-day variability on the 6MWT
Time Frame
Pre and post (after 12 weeks)
Title
Functional Assessment of Cancer Therapy General (FACT - G)
Description
27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being
Time Frame
Pre and post (after 12 weeks)
Title
Functional Assessment of Cancer Therapy Fatigue (FACT - F)
Description
40-item measure that assesses self-reported fatigue and its impact upon daily activities and function
Time Frame
Pre and post (after 12 weeks)
Title
Depression Anxiety Stress Scales (DASS)
Description
42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress.
Time Frame
Pre and post (after 12 weeks)
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
A self-report questionnaire that assesses sleep quality over a 1-month time interval
Time Frame
Pre and post (after 12 weeks)
Title
Godin-Shephard Leisure-Time Physical Activity Questionnaire
Description
Questionnaire used to identify self-reported leisure-time physical activity
Time Frame
Pre and post (after 12 weeks)
Title
Age
Description
Age (years)
Time Frame
Pre and post (after 12 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Bouchard
Phone
5064433908
Email
dboucha1@unb.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Bouchard
Organizational Affiliation
University of New Brunswick
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Brunswick
City
Fredericton
State/Province
New Brunswick
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Bouchard
Phone
5064433908
Email
dboucha1@unb.ca
Facility Name
Memorial University of Newfoundland
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin McGowan
Phone
7098647269
Email
emcgowan@mun.ca
Facility Name
University of Prince Edward Island
City
Charlottetown
State/Province
Prince Edward Island
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Travis Saunders
Phone
9025660641
Email
trsaunders@upei.ca

12. IPD Sharing Statement

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Physical Activity Levels and Functional Improvement in Breast Cancer Survivors

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