The AYA Oncology Self-care Movement (#AYAOSM)

July 20, 2026 updated by: Alex Psihogios, Northwestern University

The AYA Oncology Self-care Movement: An Influencer-driven Social Media Intervention for Oral Chemotherapy Adherence

This trial will test the impact of a social media intervention for improving oral chemotherapy adherence among adolescents and young adults (AYAs) with acute lymphoblastic leukemia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

For adolescents and young adults (AYAs) who meet inclusion criteria, trained staff will introduce the study and confirm eligibility using a standardized checklist. For AYAs <18 years old, we will conduct enrollment with AYAs and their parent/legal guardian together, as we have successfully done before.

After study procedures are thoroughly explained and questions are answered, informed written eConsent and eAssent (AYAs <18) will be obtained. Across aims, AYAs will then complete a baseline questionnaire (assessing demographics, cancer information, and perceived medication adherence and self-management abilities). Electronic health record (EHR) review will also occur, with release forms obtained for AYAs outside our centers.

Trial data collection will occur over 6-months. All enrolled AYAs will complete baseline (T1) measures (~20 minutes) online via REDCap. All enrolled participants will be provided with and receive a tutorial on a validated electronic adherence monitor, which they will be instructed to use to monitor daily 6-MP adherence for the entire 6-month study period. For 28-days (i.e., the typical time between follow-up visits), all enrolled AYAs (both groups) will complete a run-in period involving electronic monitoring of 6-MP adherence only (no intervention) to calculate baseline adherence rates. On day 29, AYAs will complete a checklist about their usage of the electronic pill bottle (to problem-solve any barriers prior to randomization) and then be randomized to the #AYAOSM social media intervention or no message control.

Participants in both groups will be asked to continue using the electronic pill bottle to passively monitor 6-MP adherence over the next five months. Participants in both groups will also be provided with an educational website describing basic information about 6-MP.

#AYAOSM Intervention Group. For AYAs randomized to the social media condition, the intervention will begin on day 29 and last for 12 weeks. Across the 12-week intervention period, AYAs will receive ~2-3 distinct social media messages per week. Messages will be delivered using direct messaging to the participant's own social media account (e.g., TikTok or Instagram), from a study-created social media account.

Control Condition. AYAs who are randomized to the control will only receive the educational website and continue to monitor their 6-MP adherence electronically. They will not receive any of the social media messages during the 6-month period.

Following the intervention period, all participants will be asked to complete follow-up REDCap surveys of self-management variables at 4-months (T2) and 6-months (T3). In addition to self-management indices, AYAs from the social media group will complete a questionnaire measure of intervention acceptability at T2. Some AYAs will also be asked to complete an interview about their experiences with the intervention. Electronic pill bottles will be returned to the study team to download data at T3.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Contact:
        • Principal Investigator:
          • Alexandra Psihogios, Ph.D.
      • Chicago, Illinois, United States, 60611
        • Northwestern University
        • Contact:
        • Sub-Investigator:
          • Alexandra Psihogos, PhD
        • Principal Investigator:
          • Betina Yanez, Ph.D.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Lisa Schwartz, PhD
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
        • Principal Investigator:
          • Michael Roth, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 15-25 years old
  • Diagnosed with acute lymphoblastic leukemia (ALL)
  • Taking 6-mercpatopurine (6-MP) as part of their maintenance treatment with at least 6-months remaining
  • Be able to speak and read English
  • Have at least one active social media account (e.g., Instagram, TikTok) or be willing to download a platform for the study
  • Endorse missing a 6-MP dose in the prior month and/or at least one adherence barrier.

Exclusion Criteria:

  • Cognitive impairments that would limit ability to complete measures, determined by the medical team
  • Absence of inclusion criteria above.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: #AYAOSM
Across the 12-week intervention period, participants in this condition will receive ~2-3 distinct, tailored social media messages per week aimed at promoting 6-mercaptopurine (6-MP) adherence. Messages will be delivered using direct messaging to the participant's own social media account (e.g., TikTok or Instagram), from a study-created social media account. Messages will feature the influencers (i.e., their own images/videos) and/or be branded with their account handles to signify their involvement in creating the message. Participants will also receive access to an educational website.
Behavioral: Educational Website
Website providing basic information about 6-mercaptopurine (e.g., type, what it is used for, strategies for remembering to take it)
Behavioral: #AYAOSM
Social media messages (videos/images) that target medication self-management skills/knowledge, self-efficacy, and social support. Messages were created in collaboration with young adult cancer survivors who are also prominent content creators or "influencers".
Active Comparator: Educational Website Only
Provides basic details about what 6-mercaptopurine is, what it is used for, and how to remember to take it.
Behavioral: Educational Website
Website providing basic information about 6-mercaptopurine (e.g., type, what it is used for, strategies for remembering to take it)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electronically-monitored Medication Adherence
Time Frame: 6-months
6-mercaptopurine (6-MP) adherence will be assessed using a Medication Event Monitoring System (MEMS), an electronic pill bottle cap that records bottle openings with date and time stamps. Adherence will be calculated as the percentage of prescribed days with a recorded bottle opening (number of days with openings/number of prescribed days × 100). The primary analysis will evaluate the proportion of participants achieving the clinically meaningful threshold of ≥95% adherent.
6-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Adherence Measure (4 items)
Time Frame: 6-months
Medication knowledge will be assessed by evaluating participants' knowledge of 1) medication name, 2) dosing frequency, 3) dose amount, and 4) medication purpose. Participant responses will be compared with the prescribed medication regimen documented in the electronic health record. Scores range from 0 to 4, with higher scores indicating greater medication knowledge.
6-months
PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment - Short Form (8 items)
Time Frame: 6-months
A validated, patient-reported instrument designed to assess an individual's confidence in their ability to successfully perform specific tasks or behaviors related to managing a long-term medical health condition. Items are rated on a Likert scale and scored using the PROMIS scoring system, with higher T-scores indicating greater self-efficacy for managing medications and treatment.
6-months
Theory of Planned Behavior Questionnaire (3 items)
Time Frame: 6-months
Three adapted items from the Theory of Planned Behavior Questionnaire assessing descriptive norms, injunctive norms, and identification with the referent group. Responses are measured on a 7-point Likert scale, with higher scores indicating stronger endorsement of each construct.
6-months
PROMIS Emotional Support and Information Support - Short Forms (8 items each)
Time Frame: 6-months
PROMIS® Emotional Support and Information Support Short Forms (8 items each). Higher scores indicate greater perceived emotional support and information support.
6-months
Objective engagement with social media intervention
Time Frame: 12-week intervention period
Objective engagement with private social media messages will be assessed among participants in the intervention group using platform analytics. Measures include the percentage of messages viewed, the percentage of messages liked, and the number of text responses. Text responses will be qualitatively coded to characterize participant engagement.
12-week intervention period
Implementation barriers and facilitators
Time Frame: 6-months
Semi-structured interview guides, tailored to each stakeholder group, will be informed by the updated Consolidated Framework for Implementation Research (CFIR). Following presentation of representative social media intervention messages, participants will be asked about perceived implementation barriers and facilitators related to the intervention, including characteristics of the innovation (e.g., design, credibility, relative advantage), individual factors (e.g., capability, opportunity, motivation), inner setting (e.g., mission alignment, compatibility, infrastructure), and outer setting (e.g., policies, partnerships, and societal influences).
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

July 20, 2026

First Posted (Actual)

July 24, 2026

Study Record Updates

Last Update Posted (Actual)

July 24, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00224160
  • R37CA299904 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

To facilitate data use, the study will use standard processing and documentation protocols adopted by the Inter-university Consortium for Political and Social Research (ICPSR). De-identified patient-reported surveys, coded interview data, aggregate adherence data across the three RCT timepoints, and aggregate engagement with the social media intervention will be preserved and shared. Participant identifiers will not be shared. Study documentation (in PDF format) that will made publicly available to the research community.

IPD Sharing Time Frame

Scientific data underlying peer-reviewed journal articles will be made accessible no later than the date on which the article is first made available in print or electronic format. Any study findings not disseminated through peer-reviewed journal articles will be shared by the end of the performance period unless the grant enters a no-cost extension (in which case the data will be shared by the end of the extended performance period).

IPD Sharing Access Criteria

Deidentified patient-reported surveys, coded interview data, aggregate adherence data across the three RCT timepoints, and aggregate engagement with the social media intervention will be made available to the public. Users of public use data must register with ICPSR and agree to the Terms of Use, which are designated to protect study participants by limited data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, and requiring immediate reporting of any detected disclosure of study participant identity. Data users also agree not to share or redistribute data downloads.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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