Mobile Health Intervention for Leukemia

Overseen By Alexandra M Psihogios, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Must be taking: 6-mercaptopurine

Disqualifiers: Cognitive impairments, others

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

Compensation: Varies

Number of Visits: 2

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile tool called AYA ADAPTS (ADherence Assessments and Personalized Timely Support), which sends personalized messages to help young people with acute lymphoblastic leukemia (ALL) adhere to their oral chemotherapy routine. Participants may receive daily messages encouraging medication adherence, though some days may pass without any messages. Eligible participants include teens and young adults, aged 14-29, with ALL or lymphoma, who are currently on maintenance therapy and prescribed 6-mercaptopurine. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance medication adherence for young patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, since participants must be prescribed 6-mercaptopurine (6MP), it seems you will continue taking this medication during the study.

What prior data suggests that this mobile health intervention is safe for promoting oral chemotherapy adherence in adolescents and young adults with leukemia?

Research has shown that the AYA ADAPTS program, which sends personalized messages to participants' phones, helps young people remember to take their oral chemotherapy. Receiving these messages poses no specific safety concerns, as they do not constitute medical treatment.

The trial currently aims to determine the program's practicality and user satisfaction. Researchers are still assessing its effectiveness and user experience. Since the program is not a drug or physical treatment, the main risks may involve privacy or technology use, but no major safety issues have been reported.

In summary, the AYA ADAPTS program is considered safe, with no serious problems reported from similar mobile health methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AYA ADAPTS intervention because it introduces a novel approach to improving adherence to oral chemotherapy for leukemia patients. Unlike traditional treatments that focus solely on medication, this method uses contextually-tailored mobile messages to support patients in sticking to their treatment plans. This personalized digital support is unique in that it adapts to the patient's daily context, increasing the likelihood of consistent medication intake, which is crucial for effective cancer treatment. By integrating modern technology into patient care, this approach has the potential to enhance outcomes and provide valuable insights into behavioral health interventions.

What evidence suggests that this mobile health intervention is effective for promoting chemotherapy adherence in leukemia?

Research has shown that teenagers and young adults with cancer often struggle to take their oral chemotherapy as directed, increasing the risk of cancer returning. The trial tests the AYA ADAPTS program, which addresses this issue by sending personalized and timely text messages. Participants in one arm of the trial receive contextually-tailored mobile messages designed to remind and encourage adherence to medication schedules. A study on this program highlighted its focus on ease of use and personalization to each individual's needs. This personalized support could improve adherence to treatment, making it an important tool for managing acute lymphoblastic leukemia (ALL). ^{6 7 8 9 10}

Who Is on the Research Team?

Alexandra M Psihogios, Ph.D.

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for young people aged 14-29 with acute lymphoblastic leukemia (ALL) or lymphoma, who are in the maintenance phase of treatment. They must have completed at least one cycle and have a month left, be taking 6-mercaptopurine (6MP), and understand English. Those under 18 need caregiver consent.

Inclusion Criteria

I am proficient in English.

AYA

I am between 14 and 29 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 12 months

Run-in

Participants electronically monitor 6-MP adherence with eCAPs to establish baseline adherence

4 weeks

1 visit (in-person) to return eCAPS

Intervention

Participants use the ADAPTS app to receive contextually-tailored mobile messages to promote oral chemotherapy adherence

4 weeks

Daily app usage

Follow-up

Participants complete acceptability surveys and exit interviews to assess intervention satisfaction and feasibility

1 week

1 visit (in-person) for survey and interview

What Are the Treatments Tested in This Trial?

Interventions

• AYA ADAPTS (ADherence Assessments and Personalized Timely Support)

Trial Overview The study tests a mobile health intervention called ADAPTS to help these young patients stick to their oral chemotherapy schedule. It's a small trial focused on seeing if this approach is practical and well-received by participants.

How Is the Trial Designed?

Group I: Contextually-tailored Mobile Messages for Adherence Experimental Treatment 1 Intervention

AYA participants will be micro-randomized to receive contextually-tailored mobile messages designed to promote their oral chemotherapy adherence, with a 60% probability of receiving a contextually-tailored message each day.

Group II: No messages Active Control 1 Intervention

All participants will also be micro-randomized to not receive messages on some days of the intervention (\~40% of the time).

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40346736/

Human-Centered Design of a Personalized Digital Health ... By developing ADAPTS with AYAs and their caregivers, this digital health intervention offers a novel and patient-centric approach to enhancing adherence.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8571686/

Understanding Adolescent and Young Adult 6 ... Adolescents and young adults (AYAs) with cancer demonstrate suboptimal oral chemotherapy adherence, increasing their risk of cancer relapse.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/pdf/10.1002/pbc.31756

Human‐Centered Design of a Personalized Digital Health ... Addressing this gap, this study describes the human-centered design of a personalized app intervention to support AYA adherence to 6-MP. Fewer ...

4. esmoopen.com esmoopen.com/article/S2059-7029(25)01698-9/fulltext

Minimum standards of specialist adolescent and young ... In 2022, according to the Global Cancer Observatory, >115 000 adolescents and young adults (AYAs; aged 15-39 years) were diagnosed with ...

5. rylazepro.com rylazepro.com/aya-treatment-guidelines

AYA Treatment Guidelines for Acute Lymphoblastic Leukemia ALL outcomes have improved over the past 40 years in pediatric patients, while AYA patients* have inferior outcomes compared to the pediatric population2,3.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03932903

NCT03932903 | Mobile Health Intervention to Support Oral ... AYA participants will be micro-randomized to receive contextually-tailored mobile messages designed to promote their oral chemotherapy adherence, with a 60% ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-02975

ADAPTS Mobile App to Promote Oral Chemotherapy ... The ADAPTS mobile app may help AYAs and their caregivers better manage maintenance chemotherapy and improve overall medication adherence to improve survival ...

8. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/235053

Mobile Health Intervention to Support Oral Chemotherapy ... AYA participants will be micro-randomized to receive contextually-tailored mobile messages designed to promote their oral chemotherapy adherence ...

9. reporter.nih.gov reporter.nih.gov/project-details/11227081

The AYA Oncology Self-Care Movement (#AYAOSM) Prior research has shown that nearly 50% of AYAs had suboptimal oral chemotherapy adherence (defined as <95% adherent), increasing their relapse risk 2.5-fold.

10. scholars.northwestern.edu scholars.northwestern.edu/en/projects/using-real-time-mobile-health-approaches-to-understand-and-promot

Using Real Time Mobile Health Approaches to Understand ... In Aim 3, the just-in-time adaptive mobile intervention called AYA ADAPTS (Adherence Assessments and Personalized Timely Support) will be pilot tested in a ...