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

February 17, 2021 updated by: University of New Brunswick

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • New Brunswick
      • Fredericton, New Brunswick, Canada
        • Recruiting
        • University of New Brunswick
        • Contact:
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Recruiting
        • Memorial University of Newfoundland
        • Contact:
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada
        • Recruiting
        • University of Prince Edward Island
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Walking speed
Time Frame: Pre and post (after 12 weeks)
6-minute walk test (meters walked)
Pre and post (after 12 weeks)
Balance
Time Frame: Pre and post (after 12 weeks)
One leg stand test (seconds)
Pre and post (after 12 weeks)
Strength, Hand grip
Time Frame: Pre and post (after 12 weeks)
Amount of force that can be exerted during grip squeeze (kg)
Pre and post (after 12 weeks)
Strength, Chair stand test
Time Frame: Pre and post (after 12 weeks)
Chair stand test, number of chair stand in 30 seconds
Pre and post (after 12 weeks)
Flexibility, back scratch test
Time Frame: Pre and post (after 12 weeks)
Back scratch test (cm)
Pre and post (after 12 weeks)
Flexibility, sit and reach
Time Frame: Pre and post (after 12 weeks)
Sit and reach test
Pre and post (after 12 weeks)
Physical Activity Level
Time Frame: Pre and post (after 12 weeks)
Pedometer to determine minutes in moderate-vigorous physical activity and steps per day
Pre and post (after 12 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Attendance
Time Frame: Pre and post (after 12 weeks)
Amount of exercise sessions attended during the 12-week program
Pre and post (after 12 weeks)
Weight
Time Frame: Pre and post (after 12 weeks)
Weight of individual (kg)
Pre and post (after 12 weeks)
Height
Time Frame: Pre and post (after 12 weeks)
Height of individual (cm)
Pre and post (after 12 weeks)
Resting Blood Pressure
Time Frame: Pre and post (after 12 weeks)
Systolic and diastolic blood pressure (mmHg)
Pre and post (after 12 weeks)
Resting Heart Rate
Time Frame: Pre and post (after 12 weeks)
Resting heart rate (beats per minute)
Pre and post (after 12 weeks)
Body-mass Index
Time Frame: Pre and post (after 12 weeks)
Measure of body fat based on height and weight (kg/m^2)
Pre and post (after 12 weeks)
Waist Circumference
Time Frame: Pre and post (after 12 weeks)
Measurement around the waist (cm)
Pre and post (after 12 weeks)
FANTASTIC Lifestyle Checklist
Time Frame: Pre and post (after 12 weeks)
Meaningful improvement above day-to-day variability on the 6MWT
Pre and post (after 12 weeks)
Functional Assessment of Cancer Therapy General (FACT - G)
Time Frame: Pre and post (after 12 weeks)
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)
Time Frame: Pre and post (after 12 weeks)
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)
Time Frame: Pre and post (after 12 weeks)
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)
Time Frame: Pre and post (after 12 weeks)
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
Time Frame: Pre and post (after 12 weeks)
Questionnaire used to identify self-reported leisure-time physical activity
Pre and post (after 12 weeks)
Age
Time Frame: Pre and post (after 12 weeks)
Age (years)
Pre and post (after 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of New Brunswick

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Quebec Breast Cancer Foundation
Ultramar

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Danielle Bouchard, University of New Brunswick

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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