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Not yet recruitingNCT07724652#AYAOSMUpdated Oct 30, 2026

The AYA Oncology Self-care Movement

An interventional study of Educational Website and #AYAOSM in Acute Lymphobkastic Leukemia and Medication Adherence, sponsored by Northwestern University. Not yet recruiting at 4 sites in United States. Open to participants aged 15 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Northwestern University · Not applicable, Interventional, and Supportive care

Updated Oct 30, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
15 Years to 25 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Medication Adherence by Northwestern University — 2 open to participants now, 2 under way, none of them phase 3. Medication Adherence · Northwestern University.

Planned enrollment
5th of 11
200 · median 119
Started
2027
the only one that year
No phase
11 of 11
2 open now
Registered
10th of 11
by date

Among the 11 studies in Medication Adherence by Northwestern University, this one is the 5th largest by planned enrollment, is the only one that started in 2027, is one of 11 with no phase, and was the 10th registered.

By phase

11 studies; the count open now beside each. This study's row is marked.

No phasethis study11 · 2 open

By the year they started

First in 2012; this study’s year is marked. 1 started in 2027.

Size and results

Median enrollment 119 across the 11 interventional studies. Of the 9 that completed or were terminated, 6 (67%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 11 studies in Medication Adherence by Northwestern University, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Acute Lymphobkastic Leukemia
  • Medication Adherence

Keywords

  • Adolescents and young adults
  • cancer
  • medication adherence
  • social media
  • oral chemotherapy
  • digital health
  • leukemia
04

Who can participate

Ages eligible
15 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Cognitive impairments that would limit ability to complete measures, determined by the medical team
  • Absence of inclusion criteria above.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
200 participants (estimated)

Study arms

  • 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 · Behavioral: #AYAOSM

  • 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

Interventions

  • BehavioralEducational 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".

06

What researchers measure

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.

    Time frame: 6-months

Secondary outcomes

  1. Medication Adherence Measure (4 items)

    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.

    Time frame: 6-months

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

    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.

    Time frame: 6-months

  3. Theory of Planned Behavior Questionnaire (3 items)

    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.

    Time frame: 6-months

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

    PROMIS® Emotional Support and Information Support Short Forms (8 items each). Higher scores indicate greater perceived emotional support and information support.

    Time frame: 6-months

  5. Objective engagement with social media intervention

    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.

    Time frame: 12-week intervention period

  6. Implementation barriers and facilitators

    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).

    Time frame: 6-months

07

Study locations

4 sites
08

References and documents

Publications

  • 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. PubMed 36602026 ↗
  • 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. PubMed 40346736 ↗
  • 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. PubMed 22564992 ↗
  • 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. PubMed 38408282 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2027; primary completion for Aug 2030, 42 months later.

Of 425 non-industry interventional studies with no phase under Medication Adherence, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's planned 42 months is above that.

Counting every sponsor, half of 442 studies reached it within 21 months; a quarter within 11 and three quarters within 41.

Start moved once since we started tracking on Sep 25, 2026: Nov 2026 → Feb 2027, on Oct 30, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2026
First posted
Jul 24, 2026
StartEst.
Feb 1, 2027was Nov 2026
Primary completionEst.
Aug 2030
CompletionEst.
Aug 2030
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Nov 1, 2026→Feb 1, 2027
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    Start date Nov 1, 2026→Feb 1, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07724652
Responsible party
Alex Psihogios (Assistant Professor, Northwestern University) — Principal investigator
First posted
Jul 24, 2026
Start date
Feb 1, 2027 (estimated)
Primary completion
Aug 2030 (estimated)
Completion
Aug 2030 (estimated)
Last update
Oct 30, 2026

Study contacts

Alexandra Psihogios, Ph.D.
Contact
alex.psihogios@northwestern.edu
240-994-6546

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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