mHealth Strategies for Cancer Survivors
(AYAWell Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to help young cancer survivors manage their weight using mobile health (mHealth) tools. It compares a guided program, the AYA WELL Intervention, which includes personalized nutrition and exercise goals, to a self-guided approach with digital tools and peer support. The trial seeks participants aged 18-39 who were diagnosed with cancer as teenagers or young adults, have completed treatment at least six months ago, and are currently dealing with overweight or obesity. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance weight management strategies for young cancer survivors.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain medications that affect appetite or weight, unless you are on a stable dose of SSRIs (a type of antidepressant) for 3 months.
What prior data suggests that this mHealth intervention is safe for adolescent and young adult cancer survivors?
Research shows that digital health programs, such as the AYA WELL program, are generally safe for young cancer survivors. Studies with similar digital tools have found that participants handle them well. For instance, a study with a positive psychology chatbot for young cancer survivors showed good participation and no serious safety issues. Although specific safety data for the AYA WELL program is not yet available, other studies using digital tools and personalized health advice have not reported major problems. This suggests the program is likely safe for participants.12345
Why are researchers excited about this trial?
Researchers are excited about the mHealth strategies being tested for cancer survivors because they offer a personalized and interactive approach to recovery. Unlike standard care options that might include general advice on diet and exercise, this intervention utilizes a mobile web app to provide tailored goals for nutrition and physical activity, enriched with psychoeducation and behavioral skills training. The inclusion of digital tools like a smart scale and activity tracker, combined with a moderated social networking group, fosters a supportive community and encourages daily engagement. This comprehensive, tech-driven approach aims to enhance self-monitoring and long-term well-being in a way that traditional treatments do not.
What evidence suggests that this trial's treatments could be effective for weight management in cancer survivors?
Research shows that mobile health (mHealth) tools can help young cancer survivors manage their weight. Studies have found that these digital tools can improve exercise and eating habits in this group. In this trial, participants in the intervention arm will receive the AYA WELL Intervention, which offers personalized nutrition and exercise goals, training in healthy habits, and peer support through a mobile app. Users of similar digital methods have reported positive changes in their health behaviors. This evidence suggests that the AYA WELL Intervention could effectively help cancer survivors manage their weight.16789
Who Is on the Research Team?
Jessica Gokee LaRose, PhD
Principal Investigator
Virginia Commonwealth University
Carmina G. Valle, PhD, MPH
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
This trial is for young adults who had cancer between ages 15-39, are now 18-39 years old, finished treatment at least six months ago, and have a BMI of 25-50. They should be within ten years of their first diagnosis without progressive disease or new cancers.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a 6-month mHealth weight management intervention or self-guided program
Maintenance
Participants continue with peer support only for weight maintenance
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AYA WELL Intervention
- Self-Guided
Trial Overview
The study compares a tailored mHealth weight management program with self-guided tools plus health education and peer support for adolescent and young adult cancer survivors over one year. The effectiveness will be measured at different intervals.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Intervention participants will receive a theory-based mHealth intervention that includes personalized nutrition and physical activity goals, psychoeducation, and evidence-based behavioral skills training delivered via a mobile web app with active content during the first 6 months, provision of digital tools to facilitate self-monitoring (a smart scale and physical activity tracker), an individual video kick-off session, text messages, and access to a closed social networking group with moderated prompts from study staff to foster peer support. Participants are encouraged to log in to web app daily to interact with self-monitoring and behavioral guidance instruction, activities, and feedback.
Self-guided participants will receive digital tools (a smart scale and activity tracker), an individual video kick-off session, quarterly informational newsletters, and a moderated but non-prompted (by study staff) closed social networking group to enable peer support.
Find a Clinic Near You
Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
Virginia Commonwealth University
Collaborator
National Cancer Institute (NCI)
Collaborator
Citations
Study Details | NCT06848491 | Using Tailored mHealth ...
The AYA WELL study is a 2-arm randomized clinical trial to test the efficacy of a theory-based, mHealth weight management intervention adapted specifically for ...
Using Tailored mHealth Strategies to Promote ... - NIH RePORTER
Thus, we propose to develop a 6-month mHealth weight management intervention designed specifically for AYA cancer survivors and test its efficacy in a ...
Using Tailored mHealth Strategies to Promote Weight ...
The AYA WELL study is a 2-arm randomized clinical trial to test the efficacy of a theory-based, mHealth weight management intervention adapted ...
Behavior change techniques in physical activity and dietary ...
Interventions improved PA outcomes in AYA cancer survivors. Most studies were pilot or feasibility trials, lasting three months. Future research ...
Digital Health Interventions for Adolescent and Young ...
This narrative review describes the evidence regarding digital health interventions targeting adolescent and young adult (AYA) cancer survivors.
Contextual Predictors of Engagement in a Tailored ...
For cancer survivors, in particular, findings from a positive psychology chatbot intervention showed that YA cancer survivors who engaged in ...
Design and methods of the EMPOWER full factorial trial
Upon trial completion, we will have an optimized, digital health intervention to enhance psychological well-being among AYA cancer survivors. EMPOWER will ...
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bmcdigitalhealth.biomedcentral.com
bmcdigitalhealth.biomedcentral.com/articles/10.1186/s44247-024-00064-1a randomized controlled pilot trial | BMC Digital Health
The PREVENT digital intervention may provide improvements in preventive behaviors among AYA cancer survivors by supporting care teams with ...
Using Tailored mHealth Strategies to Promote Weight ...
AYA WELL is a multi-site randomized clinical trial to test the efficacy of a 6-month theory-based, mHealth weight management intervention ...
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