Cancer Exercise: Evaluation of a Mobile App in Breast Cancer Survivors

NCT ID: NCT06791018

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-23
• Study Completion Date: 2026-05-20

Brief Summary

This study will examine whether a mobile app increases exercise levels in breast cancer survivors after treatments, reduces fatigue, and improves physical functions. This experimental study has 200 participants placed into one of two groups. One group will be asked to use the cancer-specific exercise app over 12 weeks, and the other group will receive the cancer exercise guidelines. Exercise will be measured by self-report questionnaires before and after the intervention and three months later. Self-report questionnaires will measure fatigue and quality of life. This research will determine whether a simple mobile app helps increase exercise in breast cancer survivors. Mobile apps to increase exercise may be provided to all breast cancer survivors after treatments to help them recover and possibly improve survival.

Detailed Description

Exercise is beneficial for breast cancer survivors in alleviating treatment side effects, improving quality of life, and possibly survival. Exercise guidelines for cancer survivors recommend 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic exercise per week and two days of resistance training. However, the number of breast cancer survivors meeting those guidelines declines during treatments because of symptoms such as fatigue, depression, muscle loss, and treatment toxicity. Mobile applications (apps) are promising tools with the potential to overcome barriers to exercise, such as cost, accessibility, time, and travel, which may reduce social health inequalities. Distanced-based interventions, including mobile apps, yield noteworthy results with favorable responses from cancer survivors. However, the literature provides few details regarding the content and features of mobile apps, hindering the understanding of the potential benefits for cancer survivors. The mobile app Cancer Exercise, developed based on Social-Cognitive Theory incorporating several evidence-based behavior change techniques, has been freely available to cancer survivors since 2020. No study to date has examined the efficacy of any existing mobile app for increasing exercise levels and improving outcomes of breast cancer survivors.

The primary aim of this study is to test the efficacy of the mobile app compared to usual care in increasing exercise levels in breast cancer survivors. The secondary aims are to (1) test the efficacy of the app for reducing fatigue and improving quality of life and physical function, (2) examine the effects of the app on motivation, and (3) determine if the app performs differently in diverse subgroups based on demographic (e.g., age, education, ethnicity, and geography) and clinical variables (e.g., disease stage, previous treatments). It was hypothesized that, compared to usual care, the Cancer Exercise app would improve exercise, fatigue, quality of life, physical function, and motivation, similarly across diverse subgroups.

Individuals diagnosed with stage I-III breast cancer (n=200) will be recruited through the Alberta Cancer Registry and randomly assigned to the app intervention (n=100) or usual care (n=100) receiving exercise guidelines. The goal of the intervention group will be to perform at least 90 minutes of aerobic exercise and two days of resistance exercise per week over 12 weeks. Exercise will be measured the Godin Leisure-Time Exercise Questionnaire at baseline, 12 weeks, and 6 months. The European Organization for Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-C30) will measure quality of life. Analysis of covariance will compare outcomes between groups while adjusting for important demographic and clinical variables. Interactions (subgroup analysis) involving demographic and clinical variables will also be explored.

This research will provide the first evidence of the efficacy of a mobile app for increasing exercise in breast cancer survivors. The results will contribute to regulation in designing app-based exercise interventions to minimize the potential risk of injury and adverse outcomes for breast cancer survivors. With an effective and tested mobile app, healthcare providers may leverage this resource to facilitate safe and easy exercise referrals for patients.

Conditions

Breast Cancer; Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cancer-specific exercise app

Participants randomized in this group will be asked to use the app for 12 weeks. Participants will be ask to preferably spread each exercise session over different days of the week. While exercise equipment is not required, the app includes options for using elastic resistance bands or dumbbells. Following baseline assessment and randomization, participants in the intervention group will receive a brief instructional video on how to download and use the app, along with access to a website offering support materials, guidelines, and additional instructional videos. All participants will complete questionnaires at baseline, 12 weeks (post-intervention), and 3 months follow-up.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

Participants will be asked to use a cancer-specific exercise mobile app for 12 weeks. The program is designed to achieve the goal of exercising for at least 90 minutes per week, including aerobic exercise three times a week and resistance training twice a week. While exercise equipment is not required, the app supports the optional use of an elastic resistance band or a pair of dumbbells. The app comes with various features to support the exercise journey. Participants will be able to track their progress through periodic testing, access a library of resources that includes information on exercise, and log any additional workouts they perform outside the app. The exercise prescription will be tailored to daily fatigue levels that will be rated before each workout. This ensures that the program is customized to meet individual needs and abilities.

Usual care

This group will received the ACSM exercise guidelines.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

Participants will be asked to use a cancer-specific exercise mobile app for 12 weeks. The program is designed to achieve the goal of exercising for at least 90 minutes per week, including aerobic exercise three times a week and resistance training twice a week. While exercise equipment is not required, the app supports the optional use of an elastic resistance band or a pair of dumbbells. The app comes with various features to support the exercise journey. Participants will be able to track their progress through periodic testing, access a library of resources that includes information on exercise, and log any additional workouts they perform outside the app. The exercise prescription will be tailored to daily fatigue levels that will be rated before each workout. This ensures that the program is customized to meet individual needs and abilities.

Intervention Type: OTHER

Other Intervention Names

Cancer-specific exercise app

Eligibility Criteria

Inclusion Criteria

• ≥ 18 years of age, diagnosed with histologically confirmed stage I, II, or III breast cancer, > 1 to 5 years after diagnosis (2020-2024) and completed all treatments except hormone therapy, own a smartphone (Apple or Android), able to read and understand English, and interested in increasing exercise.

Exclusion Criteria

• Not being medically cleared to participate in the exercise intervention by a certified exercise physiologist using the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) (e.g., known cardiac disease or uncontrolled hypertension), evidence of cancer recurrence, stage IV metastatic breast cancer and unable to walk without material or physical support.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Exercise Oncology Research Laboratory, Faculty of Kinesiology, Sport and Recreation, University of Alberta.

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Kerry Courneya, PhD

Role: CONTACT

kerry.courneya@ualberta.ca

780-492-1031

Myriam Filion, PhD Student

Role: CONTACT

mfilion@ualberta.ca

780-492-8246

Facility Contacts

Kerry Courneya, PhD

Role: primary

kerry.courneya@ualberta.ca

780-492-1031

Miriam Fillion

Role: backup

mfilion@ualberta.ca

780-492-8246

Other Identifiers

HREBA.CC-24-0455

Identifier Type: -

Identifier Source: org_study_id