mHealth Physical Activity Intervention for Cancer Survivors

(AYA-PACT Trial)

Not currently recruiting at 1 trial location

Overseen By Pamela Round

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: AHS Cancer Control Alberta

Disqualifiers: Health problems, Pregnancy, High physical activity

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a mobile health program can help young adults who recently completed cancer treatment become more active. It includes a personalized fitness plan, an activity tracker, and support through texts and calls. Participants may receive either this program or general health information. The trial suits cancer survivors in Alberta, aged 15 to 39 at diagnosis, who finished treatment in the past year and want to increase their physical activity. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could enhance post-treatment recovery.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it mentions that participants can continue 'maintenance' therapy to prevent cancer recurrences.

What prior data suggests that this physical activity intervention is safe for cancer survivors?

Research has shown that mobile health tools, like the one being tested, are generally safe for cancer survivors. These tools often incorporate technology such as fitness trackers and personalized activity plans to enhance exercise levels. Studies have found that these methods can increase physical activity without causing major side effects.

Strong evidence supports that mobile health programs with personal contact, including motivational messages and check-in calls, are safe and effective. Participants in similar studies have not reported any major safety issues, indicating these methods are well-tolerated.

Overall, using technology to promote physical activity in cancer survivors is a safe way to improve health and well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mHealth Physical Activity Intervention for cancer survivors because it uses mobile technology to encourage increased physical activity, a method not typically emphasized in conventional cancer care. Unlike standard treatments, which often focus on medication or chemotherapy, this intervention aims to boost moderate to vigorous exercise levels by 90 minutes per week, potentially enhancing overall health and recovery. By leveraging mobile health tools, this approach offers a flexible and personalized way for survivors to integrate physical activity into their daily lives, which might lead to improved outcomes and quality of life.

What evidence suggests that this mHealth physical activity intervention is effective for increasing physical activity in cancer survivors?

Research has shown that mobile health (mHealth) programs can help cancer survivors become more active. In this trial, participants in the mHealth Physical Activity Intervention arm will undergo a 12-month intervention to increase their moderate-to-vigorous intensity physical activity by 90 minutes per week above baseline. One study found that while participants didn't increase their overall physical activity, they spent more time on moderate-to-vigorous exercises. Another study found that these mobile programs led to small-to-moderate improvements in heart and lung fitness. Additionally, breast cancer patients using an mHealth program significantly improved their walking and overall activity levels. These findings suggest that mobile technology can be a promising way to help cancer survivors stay active and improve their fitness. ^{6 7 8 9 10}

Who Is on the Research Team?

Christine Friedenreich

Principal Investigator

Alberta Health services

Miranda Fidler-Benaoudia

Principal Investigator

Alberta Health services

Are You a Good Fit for This Trial?

This trial is for young adult cancer survivors in Alberta, aged 15-39, who finished their main cancer treatment within the last year. They must be able to communicate in English and have regular internet access and a mobile phone with texting. It's not for those who can't walk for exercise, are pregnant or planning pregnancy soon, or already very active.

Inclusion Criteria

Have a mobile phone with a text messaging plan

Have access to the Internet on at least a weekly basis

I am willing to be assigned to any treatment group in the study.

Exclusion Criteria

You exercise for more than 300 minutes per week with moderate-to-vigorous intensity on a regular basis.

I cannot walk for exercise as determined by a health survey.

Currently pregnant or planning to become pregnant within the next 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete fitness testing and questionnaires

1-2 weeks

1 visit (in-person)

Intervention

Participants receive a 12-month mobile health intervention to increase physical activity

12 months

3 visits (in-person) at 6, 12, and 24 months

Follow-up

Participants are monitored for long-term effectiveness of the intervention

12 months

1 visit (in-person) at 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Physical Activity

Trial Overview The study tests if a mobile health program helps increase physical activity over one year. Participants will either get educational materials only (control group) or also a personalized activity plan, an activity tracker watch, online community access, motivational texts and calls/emails (intervention group). Fitness and surveys will track progress at intervals up to two years.

How Is the Trial Designed?

Group I: mHealth Physical Activity Intervention Experimental Treatment 1 Intervention

The intervention arm will receive a 12 month mobile health (mHealth) physical activity intervention with a goal of increasing their moderate-vigorous intensity physical activity levels by 90 minutes per week above baseline

Group II: Control Active Control 1 Intervention

Controls will receive general health education materials

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials

188

Recruited

26,900+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Published Research Related to This Trial

A systematic review of 23 randomized controlled trials involving cancer survivors showed that mobile health (mHealth) interventions significantly improved physical activity and dietary habits, with 11 out of 18 studies reporting notable behavioral changes.

Participants expressed high satisfaction with the mHealth interventions, with a median satisfaction rate of 87%, indicating that these technology-based approaches are well-received and feasible for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Interventions to Promote a Healthy Diet and Physical Activity among Cancer Survivors: A Systematic Review of Randomized Controlled Trials. Wang, L., Langlais, CS., Kenfield, SA., et al.[2022]

Mobile health (mHealth) interventions, especially those including personal contact, have strong evidence for effectively increasing moderate-to-vigorous physical activity among cancer survivors, based on a review of 31 studies.

However, the evidence for mHealth interventions in increasing total activity levels and reducing sedentary behavior remains inconclusive, highlighting the need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Interventions to Address Physical Activity and Sedentary Behavior in Cancer Survivors: A Systematic Review. Khoo, S., Mohbin, N., Ansari, P., et al.[2021]

Out of 341 physical activity apps reviewed, only 67 were deemed appropriate for cancer survivors, with 46% offering a mix of aerobic and strength/stretching exercises.

The apps generally scored well in objective quality (average score of 4.11 out of 5) but were less effective in promoting knowledge and awareness about physical activity, indicating a need for better content tailored to cancer survivors' needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescribing fitness apps for people with cancer: a preliminary assessment of content and quality of commercially available apps. Martín Payo, R., Harris, J., Armes, J.[2020]

A 10-week mHealth intervention for overweight breast cancer survivors showed high engagement, with participants actively using tracking devices and completing counseling sessions, indicating the program's acceptability.

Participants experienced a significant mean weight loss of 3.38 pounds, increased daily fruit and vegetable intake, and improved physical activity levels, suggesting the intervention's potential effectiveness in promoting healthier behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot and Feasibility Test of a Mobile Health-Supported Behavioral Counseling Intervention for Weight Management Among Breast Cancer Survivors. Quintiliani, LM., Mann, DM., Puputti, M., et al.[2022]

Physical activity has been shown to significantly improve both patient-reported outcomes and physiological health in cancer survivors during and after treatment, highlighting its importance in recovery.

The review discusses ongoing phase III trials that are investigating the impact of physical activity on clinical disease endpoints, suggesting a strong focus on integrating exercise into cancer care to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putting Exercise Into Oncology Practice: State-of-the-Science, Innovation, and Future Directions. Brown, JC., Ligibel, JA.[2023]

Only 33% of cancer survivors meet the recommended physical activity guidelines of at least 150 minutes per week, highlighting a significant gap in adherence to beneficial health practices.

There is a notable variation in compliance rates across states, with Vermont having the highest at 59.9% and Louisiana the lowest at 14.8%, indicating a need for targeted interventions in states with lower physical activity levels among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are Cancer Survivors Physically Active? A Comparison by US States. Tannenbaum, SL., McClure, LA., Asfar, T., et al.[2018]

Physical activity is linked to a lower risk of developing breast cancer and recurrence, as well as improved survival rates, based on observational studies.

Engaging in physical activity can alleviate treatment-related side effects, such as fatigue from chemotherapy and musculoskeletal issues from aromatase inhibitors, highlighting its importance in breast cancer survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Breast Cancer: an Opportunity to Improve Outcomes. Peterson, LL., Ligibel, JA.[2019]

Interventions aimed at maintaining physical activity in cancer survivors were effective, resulting in a moderate increase in moderate to vigorous physical activity (MVPA) of about 65 minutes per week compared to control groups, which saw an increase of 27 minutes per week.

However, many studies included in the review had biases, primarily involving younger, more active, and well-educated participants, suggesting that future interventions should focus on older adults and those with physical limitations to ensure broader applicability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of maintenance of physical activity behaviour change in cancer survivors. Grimmett, C., Corbett, T., Brunet, J., et al.[2021]

Exercise has been shown to improve key physical health markers in breast cancer survivors, such as peak oxygen consumption, muscle strength, and cardiovascular health, which are linked to better overall health outcomes.

The review will provide recommendations for exercise interventions tailored to breast cancer survivors, highlighting the importance of physical activity in reducing risks of disability and chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically Relevant Physical Benefits of Exercise Interventions in Breast Cancer Survivors. Kirkham, AA., Bland, KA., Sayyari, S., et al.[2018]

Exercise and physical activity have therapeutic benefits for cancer survivors, improving physical function, reducing cancer-related symptoms, and enhancing overall quality of life.

Physical activity can influence cancer outcomes by altering biological pathways related to tumor initiation and may help prevent certain cancers, such as breast and colon cancer, while also addressing survivorship issues like fatigue and lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role and efficacy of exercise in persons with cancer. Eickmeyer, SM., Gamble, GL., Shahpar, S., et al.[2022]

Regular physical exercise is associated with a reduced risk of developing colorectal and breast cancer, and may also lower the risk for prostate, endometrial, and lung cancers, based on a review of recent literature.

Exercise is beneficial for cancer survivors, aiding in recovery from treatment and potentially extending survival, although specific guidelines on the optimal amount, type, and intensity of exercise are still being developed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in cancer. Rajarajeswaran, P., Vishnupriya, R.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36444676/

Effect of an mHealth intervention on physical activity outcomes ... Intervention participants did not improve their total amount of physical activity, but they did increase their moderate-to-vigorous intensity ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11381959/

A systematic review and meta‐analysis - PMC mHealth exercise interventions appear to be associated with small‐to‐moderate improvements in cardiorespiratory fitness for cancer patients and survivors.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352013224000802

Effectiveness of a theory-based tailored mHealth physical ... Compared to the baseline data, breast cancer patients in the intervention group had significant improvements in walking and overall PA after three months (P < ...

4. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.34556

Effect of an mHealth intervention on physical activity outcomes ... Intervention participants did not improve their total amount of physical activity, but they did increase their moderate-to-vigorous intensity ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04765241?term=NCT04765241&rank=1

mHealth Physical Activity Intervention for Young Cancer ... The main goal of this study is to see if a home-based, mobile health (mHealth) physical activity intervention can increase physical activity levels by at least ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9834757/

Effect of an mHealth Intervention on Physical Activity ... Young adult cancer survivors participating in an mHealth intervention did not significantly increase accelerometer-measured total physical activity after 6 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06840028

Effects of Personalized Exercise Prescriptions Through ... The purpose of this study is to evaluate the effectiveness of a personalized m-health intervention via fitness wearable (Fitbit Inspire 3) exercise app (sFitRx) ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8198944/

mHealth Interventions to Address Physical Activity and ... There is strong evidence for mHealth interventions, including personal contact components, in increasing moderate-to-vigorous intensity PA among cancer ...

9. mhealth.jmir.org mhealth.jmir.org/2017/1/e3/

Mobile Health Physical Activity Intervention Preferences in ... Background: Cancer survivors are at an elevated risk for several negative health outcomes, but physical activity (PA) can decrease those ...

10. ascopubs.org ascopubs.org/doi/10.1200/CCI.24.00014

Mapping the Evidence on the Impact of mHealth ... All studies contained multiple interventions, including physical activity, tailored information for self-management of the disease, and symptom tracker.