The AYA Oncology Self-care Movement

NCT07724652 | Not Yet Recruiting DMC

• 2 other identifiers: STU00224160R37CA299904
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Acute Lymphobkastic Leukemia; Medication Adherence

Keywords

Adolescents and young adults; cancer; medication adherence; social media; oral chemotherapy; digital health; leukemia

Outcome Measures

Primary Outcomes (1)

• Electronically-monitored Medication Adherence

  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 Outcomes (6)

• Medication Adherence Measure (4 items)

  6-months

• PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment - Short Form (8 items)

  6-months

• Theory of Planned Behavior Questionnaire (3 items)

  6-months

• PROMIS Emotional Support and Information Support - Short Forms (8 items each)

  6-months

• Objective engagement with social media intervention

  12-week intervention period

Study Arms (2)

#AYAOSM

EXPERIMENTAL

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; Behavioral: #AYAOSM

Educational Website Only

ACTIVE COMPARATOR

Provides basic details about what 6-mercaptopurine is, what it is used for, and how to remember to take it.

Behavioral: Educational Website

Interventions

Educational Website BEHAVIORAL

Website providing basic information about 6-mercaptopurine (e.g., type, what it is used for, strategies for remembering to take it)

#AYAOSM; Educational Website Only

#AYAOSM BEHAVIORAL

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".

#AYAOSM

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Cognitive impairments that would limit ability to complete measures, determined by the medical team

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (4)

• McGrady ME, Ketterl TG, Norris RE, Perentesis JP, Pettee D, Mara CA, Breen G, Pai ALH. Barriers to medication adherence among adolescents and young adults with cancer. Pediatr Blood Cancer. 2023 Mar;70(3):e30186. doi: 10.1002/pbc.30186. Epub 2023 Jan 5.

  PMID: 36602026 BACKGROUND

• Psihogios AM, El-Khatib A, Matos K, Rabbi M, Rossoff J, Dinner S, Zeng K, Picos R, Ahmed A, Patel EM, Fleisher L, Hunger SP, Pai A, Laurenceau JP, Rini C, Barakat LP, Schwartz LA, Murphy S, Yanez B. Human-Centered Design of a Personalized Digital Health Intervention to Improve Oral Chemotherapy Adherence in Adolescents and Young Adults With Hematologic Cancers. Pediatr Blood Cancer. 2025 Aug;72(8):e31756. doi: 10.1002/pbc.31756. Epub 2025 May 9.

  PMID: 40346736 BACKGROUND

• Bhatia S, Landier W, Shangguan M, Hageman L, Schaible AN, Carter AR, Hanby CL, Leisenring W, Yasui Y, Kornegay NM, Mascarenhas L, Ritchey AK, Casillas JN, Dickens DS, Meza J, Carroll WL, Relling MV, Wong FL. Nonadherence to oral mercaptopurine and risk of relapse in Hispanic and non-Hispanic white children with acute lymphoblastic leukemia: a report from the children's oncology group. J Clin Oncol. 2012 Jun 10;30(17):2094-101. doi: 10.1200/JCO.2011.38.9924. Epub 2012 May 7.

  PMID: 22564992 BACKGROUND

• Psihogios AM, Roth M, Gomez C, Hekimian-Brogan E, McQueen C, Yanez B. Partnering With Social Media Influencers to Equitably Improve Adolescent and Young Adult Cancer Outcomes: A Novel Strategy to Support Cancer Care Delivery. JCO Oncol Pract. 2024 Jun;20(6):755-760. doi: 10.1200/OP.23.00449. Epub 2024 Feb 26. No abstract available.

  PMID: 38408282 BACKGROUND

MeSH Terms

Conditions

Medication Adherence; Neoplasms; Leukemia

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Alexandra Psihogios, Ph.D.

CONTACT

240-994-6546; alex.psihogios@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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).
• 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.

Locations

US (4)