mHealth Physical Activity Intervention for Cancer Survivors

(AYA-PACT Trial)

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

287 Participants Needed

Trial Summary

What is the purpose of this trial?

In this randomized controlled trial the investigators will determine whether a mobile health intervention can increase physical activity levels in AYA cancer survivors over a one year period. The investigators will recruit 320 cancer survivors in Alberta who were diagnosed with a first cancer between the ages of 15 to 39 years and are within one year of treatment completion. Participants will be randomized into either the control group (educational information) or the intervention group (educational information; personalized physical activity plan; activity tracker watch; access to a private, online survivor community; motivational text messages and check-in calls/e-mails). All participants will complete fitness testing and questionnaires at baseline, 6 months and 12 months. A final measurement at 24 months will test long-term effectiveness.

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 data supports the effectiveness of the treatment Physical Activity, Exercise, Physical Exercise, Physical Activity Intervention for cancer survivors?

Research shows that physical activity can improve health and wellbeing after cancer, potentially reducing cancer recurrence and mortality. Exercise has been found to enhance quality of life, reduce cancer-related fatigue, and improve physical function in cancer survivors. ^{1 2 3 4 5}

Is physical activity safe for cancer survivors?

Physical activity is generally safe for cancer survivors and offers numerous health benefits, such as improved quality of life and reduced fatigue. Current guidelines support its use, and no significant safety concerns have been reported in the reviewed studies. ^{1 5 6 7 8}

How is the mHealth Physical Activity Intervention for Cancer Survivors different from other treatments?

This treatment is unique because it uses mobile health (mHealth) technology, such as smartphone apps and activity trackers, to encourage cancer survivors to be more physically active, integrating the intervention into their daily routines and providing personal contact components for better effectiveness. ^{6 9 10 11 12}

Research Team

Christine Friedenreich

Principal Investigator

Alberta Health services

Miranda Fidler-Benaoudia

Principal Investigator

Alberta Health services

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of maintenance of physical activity behaviour change in cancer survivors. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The role and efficacy of exercise in persons with cancer. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Exercise in cancer. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Clinically Relevant Physical Benefits of Exercise Interventions in Breast Cancer Survivors. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Prescribing fitness apps for people with cancer: a preliminary assessment of content and quality of commercially available apps. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Physical Activity and Breast Cancer: an Opportunity to Improve Outcomes. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Are Cancer Survivors Physically Active? A Comparison by US States. [2018]

9. Switzerland 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. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

mHealth Interventions to Address Physical Activity and Sedentary Behavior in Cancer Survivors: A Systematic Review. [2021]

11. Canada pubmed.ncbi.nlm.nih.gov

Pilot and Feasibility Test of a Mobile Health-Supported Behavioral Counseling Intervention for Weight Management Among Breast Cancer Survivors. [2020]

12. Canada pubmed.ncbi.nlm.nih.gov

Pilot and Feasibility Test of a Mobile Health-Supported Behavioral Counseling Intervention for Weight Management Among Breast Cancer Survivors. [2022]