Breast CancerNCT06791018
Cancer Exercise: Evaluation of a Mobile App in Breast Cancer Survivors
A study testing Exercise in people with Breast Cancer and Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteCanada
- Study dates
- 23 May 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Oncology Research Laboratory, Faculty of Kinesiology, Sport and Recreation, University of Alberta.
Edmonton, Alberta, T6G 2H9
About this study
Official title: Cancer Exercise: A Pragmatic Randomized Controlled Trial Evaluating a Mobile Application in Breast Cancer Survivors.
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.
Read the 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.
- Being tested
- Exercise
- Keywords
- Breast neoplasm, Digital technology, Mobile app, Exercise, Behavior
- Medical subject headings
- Breast Neoplasms, Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Cancer-specific exercise app
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.
| Study group | Role | What they receive |
|---|---|---|
| Cancer-specific exercise app | Experimental | 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. Receives: Other: Exercise |
| Usual care | No intervention | This group will received the ACSM exercise guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Level
An increase in time in moderate to vigorous exercise levels in minutes per week is the primary endpoint of this study. The efficacy of the app intervention will be assessed by the modified Leisure Score Index from the Godin Leisure-Time Exercise Questionnaire. Participants will be asked to recall their average weekly frequency and duration of light, moderate, and vigorous exercise during the past month that lasted at least 10 minutes and was done during free time. Exercise minutes/week will be calculated for moderate and vigorous exercise. Total exercise minutes will be calculated by adding aerobic minutes and strength minutes.
Measured: At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.
Secondary outcomes (8)
Health-related quality of life (HRQoL)
Assessment of health-related quality of life (HRQoL) using the European Organization for Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-C30) version 3.0.
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / quality of life scale, and six single items.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.
Cancer-Related Fatigue
Cancer-related fatigue will be assessed using the validated Functional Assessment of Cancer Therapy-Fatigue (FACT-F) sub-scale, a 13-item self-report instrument designed to measure fatigue and anemia-related concerns in individuals with cancer. Scores on the Fatigue Subscale range from 0 to 52, with higher scores indicating worse fatigue.
Fatigue will also be collected dynamically through the app as a just-in-time variable. Participants will self-report their fatigue levels using a scale of 0 to 10, where higher scores indicate greater fatigue. These app-reported measures will provide intra-individual data on fatigue fluctuations over time.
Measured: At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.
Upper Limb Function
The self-reported Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire will measure upper limb function. The DASH is a 30-item questionnaire with a 5-point Likert scale for each item, producing a score that ranges from 0 to 100. Higher scores indicate greater disability or worse upper limb function. The DASH will be assessed at baseline, post-intervention (12 weeks), and 3-month follow-up.
Measured: At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.
Exercise behavior
Exercise behavior will be assessed using the Capability, Opportunity, Motivation (COM) 6-item questionnaire developed by Keyworth et al. (2020), based on the COM-Behavior (COM-B) model framework. Participants will answer questions about factors influencing exercise behavior, such as support, accessibility, and facilities. Each question will be scored on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating better exercise behavior. The total score will reflect the overall exercise behavior of breast cancer survivors.
Measured: At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.
Capability for Exercise
Capability for exercise will be assessed using the physical and psychological capability subdomains of the COM 6-item questionnaire developed by Keyworth et al. (2020).
Each question will be scored on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater capability.
Measured: At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.
Opportunity for Exercise
Opportunity for exercise will be assessed using the physical and social opportunity subdomains of the COM 6-item questionnaire developed by Keyworth et al. (2020).
Each question will be scored on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater opportunity.
Measured: At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.
Motivation for Exercise
Motivation for exercise will be assessed using the reflective and automatic motivation subdomains of the COM 6-item questionnaire developed by Keyworth et al. (2020).
Each question will be scored on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater motivation. Data will be collected at baseline, 12 weeks, and 3 months follow-up.
Measured: At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.
Demographic characteristics
Demographic data will be collected by self-report at baseline and will include age, marital status, education, family income, number and age of children at home, employment status, geography, and ethnicity. The baseline questionnaire will also collect self-reported medical data and will include comorbidities, stage of breast cancer, date of diagnosis, treatment protocol, type of surgery (lumpectomy or mastectomy), type of treatment, and weeks since surgery.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start23 May 2025
- Primary completion20 Dec 2025
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention is a cancer-specific mobile application with the aim of increasing exercise levels in cancer survivors.
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791018
- Sponsor's protocol ID
- HREBA.CC-24-0455
- Status last verified
- Jun 2026
- First submitted
- 14 Jan 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Exercise: A Pragmatic Randomized Controlled Trial Evaluating a Mobile Application in Breast Cancer Survivors.
- ClinicalTrials.gov ID
- NCT06791018
- Acronym / sponsor ID
- HREBA.CC-24-0455
- Keywords
- Breast neoplasm, Digital technology, Mobile app, Exercise, Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 23 May 2025 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention is a cancer-specific mobile application with the aim of increasing exercise levels in cancer survivors.
| Arm | Type | Receives |
|---|---|---|
| Cancer-specific exercise app | Experimental | Other: ExerciseParticipants 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. |
| Usual care | No intervention | –This group will received the ACSM exercise guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥ 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Cancer-specific exercise appParticipants 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. | Other | Cancer-specific exercise app |
Primary outcome
Exercise Level
Time frame: At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.
An increase in time in moderate to vigorous exercise levels in minutes per week is the primary endpoint of this study. The efficacy of the app intervention will be assessed by the modified Leisure Score Index from the Godin Leisure-Time Exercise Questionnaire. Participants will be asked to recall their average weekly frequency and duration of light, moderate, and vigorous exercise during the past month that lasted at least 10 minutes and was done during free time. Exercise minutes/week will be calculated for moderate and vigorous exercise. Total exercise minutes will be calculated by adding aerobic minutes and strength minutes.
8 secondary outcomes
Health-related quality of life (HRQoL)
Time frame: At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.
Cancer-Related Fatigue
Time frame: At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.
Upper Limb Function
Time frame: At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.
Exercise behavior
Time frame: At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.
Capability for Exercise
Time frame: At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.
Opportunity for Exercise
Time frame: At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.
Motivation for Exercise
Time frame: At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.
Demographic characteristics
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Breast Cancer and Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Level (time frame: At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.