Acute Lymphobkastic Leukemia#AYAOSMNCT07724652
The AYA Oncology Self-care Movement
A study testing Educational Website and #AYAOSM in people with Acute Lymphobkastic Leukemia and Medication Adherence, run by Northwestern University at 4 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Acute Lymphobkastic Leukemia, Medication Adherence
- What is being tested?
- Educational Website and #AYAOSM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Feb 2027to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Cognitive impairments that would limit ability to complete measures, determined by the medical team
- Absence of inclusion criteria above.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Alexandra Psihogios, Ph.D., 2409946546, apsihogios@luriechildrens.org
Alexandra Psihogios, Ph.D.
Northwestern University
Chicago, Illinois, 60611
Alexandra Psihogios, Ph.D., 240-994-6546, alex.psihogios@northwestern.edu
Alexandra Psihogos, PhD
MD Anderson Cancer Center
Houston, Texas, 77030
Michael Roth, MD, 1-877-632-6789, MRoth1@MDAnderson.org
Michael Roth, MD
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Lisa Schwartz, PhD, 267-426-0355, schwartzl@chop.edu
Lisa Schwartz, PhD
About this study
Official title: 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.
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.
- Conditions
- Acute Lymphobkastic Leukemia, Medication Adherence
- Being tested
- Educational Website, #AYAOSM
- Keywords
- Adolescents and young adults, cancer, medication adherence, social media, oral chemotherapy, digital health, leukemia
- Medical subject headings
- Medication Adherence, Neoplasms, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational WebsiteBehavioural
Website providing basic information about 6-mercaptopurine (e.g., type, what it is used for, strategies for remembering to take it)
#AYAOSMBehavioural
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".
| Study group | Role | What they receive |
|---|---|---|
| #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. Receives: 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. Receives: Behavioral: Educational Website |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-months
Secondary outcomes (6)
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.
Measured: 6-months
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.
Measured: 6-months
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.
Measured: 6-months
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.
Measured: 6-months
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.
Measured: 12-week intervention period
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).
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Feb 2027 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphobkastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Alex Psihogios, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724652
- Sponsor's protocol ID
- STU00224160
- Other IDs
- R37CA299904
- Acronym
- #AYAOSM
- Status last verified
- Oct 2026
- First submitted
- 1 Jul 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 36602026Psihogios 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 40346736Bhatia 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 22564992Psihogios 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The AYA Oncology Self-care Movement: An Influencer-driven Social Media Intervention for Oral Chemotherapy Adherence
- ClinicalTrials.gov ID
- NCT07724652
- Acronym / sponsor ID
- #AYAOSM / STU00224160
- Conditions
- Acute Lymphobkastic Leukemia, Medication Adherence
- Keywords
- Adolescents and young adults, cancer, medication adherence, social media, oral chemotherapy, digital health, leukemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| #AYAOSM | Experimental | Behavioral: Educational Website, Behavioral: #AYAOSMAcross 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. |
| Educational Website Only | Active comparator | Behavioral: Educational WebsiteProvides basic details about what 6-mercaptopurine is, what it is used for, and how to remember to take it. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Cognitive impairments that would limit ability to complete measures, determined by the medical team
- Absence of inclusion criteria above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational WebsiteWebsite providing basic information about 6-mercaptopurine (e.g., type, what it is used for, strategies for remembering to take it) | Behavioural | #AYAOSM, Educational Website Only |
| #AYAOSMSocial 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". | Behavioural | #AYAOSM |
Primary outcome
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 secondary outcomes
Medication Adherence Measure (4 items)
Time frame: 6-months
PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment - Short Form (8 items)
Time frame: 6-months
Theory of Planned Behavior Questionnaire (3 items)
Time frame: 6-months
PROMIS Emotional Support and Information Support - Short Forms (8 items each)
Time frame: 6-months
Objective engagement with social media intervention
Time frame: 12-week intervention period
Implementation barriers and facilitators
Time frame: 6-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 36602026McGrady 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.
- Background: PubMed 40346736Psihogios 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.
- Background: PubMed 22564992Bhatia 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.
- Background: PubMed 38408282Psihogios 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Website and #AYAOSM in people with Acute Lymphobkastic Leukemia and Medication Adherence, run by Northwestern University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Psihogios, Ph.D. (240-994-6546, alex.psihogios@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electronically-monitored Medication Adherence (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07724652, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.