240 Participants Needed

mHealth Strategies for Cancer Survivors

(AYAWell Trial)

MD
KE
Overseen ByKaren E. Hatley, MPH, RD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

JG

Jessica Gokee LaRose, PhD

Principal Investigator

Virginia Commonwealth University

CG

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

I was diagnosed with my first invasive cancer between 15-39 years old.
I was diagnosed within the last 10 years and have no signs of cancer worsening or new cancers.
I finished my main cancer treatment 6 months ago but may be on maintenance therapy.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-month mHealth weight management intervention or self-guided program

6 months
Daily interaction with mobile app, 1 video kick-off session

Maintenance

Participants continue with peer support only for weight maintenance

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Assessments at 6 and 12 months

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Group II: Self-GuidedActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials
377
Recruited
95,900+

Virginia Commonwealth University

Collaborator

Trials
732
Recruited
22,900,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

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 RePORTERThus, 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 trialUpon trial completion, we will have an optimized, digital health intervention to enhance psychological well-being among AYA cancer survivors. EMPOWER will ...
a randomized controlled pilot trial | BMC Digital HealthThe 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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