[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07724652":3,"trial-entities:NCT07724652":165,"trial-summary:NCT07724652":169},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":47,"secondary_outcomes":52,"sex":72,"minimum_age":73,"maximum_age":74,"healthy_volunteers":75,"eligibility_criteria":76,"std_ages":87,"locations":90,"central_contacts":147,"overall_officials":149,"references":150,"see_also_links":164},"NCT07724652","STU00224160","The AYA Oncology Self-care Movement","The AYA Oncology Self-care Movement: An Influencer-driven Social Media Intervention for Oral Chemotherapy Adherence","NOT_YET_RECRUITING","2030-08","2026-07","2026-07-24","2026-11-01","Northwestern University","OTHER",true,"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.","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 \\\u003C18 years old, we will conduct enrollment with AYAs and their parent\u002Flegal guardian together, as we have successfully done before.\n\nAfter study procedures are thoroughly explained and questions are answered, informed written eConsent and eAssent (AYAs \\\u003C18) 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.\n\nTrial 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.\n\nParticipants 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.\n\n#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.\n\nControl 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.\n\nFollowing 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.",[19,20],"Acute Lymphobkastic Leukemia","Medication Adherence",[22,23,24,25,26,27,28],"Adolescents and young adults","cancer","medication adherence","social media","oral chemotherapy","digital health","leukemia","INTERVENTIONAL","SUPPORTIVE_CARE",[32],"NA",{"count":34,"type":35},200,"ESTIMATED",[37,44],{"type":38,"name":39,"description":40,"armGroupLabels":41},"BEHAVIORAL","Educational Website","Website providing basic information about 6-mercaptopurine (e.g., type, what it is used for, strategies for remembering to take it)",[42,43],"#AYAOSM","Educational Website Only",{"type":38,"name":42,"description":45,"armGroupLabels":46},"Social media messages (videos\u002Fimages) that target medication self-management skills\u002Fknowledge, self-efficacy, and social support. Messages were created in collaboration with young adult cancer survivors who are also prominent content creators or \"influencers\".",[42],[48],{"measure":49,"description":50,"timeFrame":51},"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\u002Fnumber of prescribed days × 100). The primary analysis will evaluate the proportion of participants achieving the clinically meaningful threshold of ≥95% adherent.","6-months",[53,56,59,62,65,69],{"measure":54,"description":55,"timeFrame":51},"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.",{"measure":57,"description":58,"timeFrame":51},"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.",{"measure":60,"description":61,"timeFrame":51},"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.",{"measure":63,"description":64,"timeFrame":51},"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.",{"measure":66,"description":67,"timeFrame":68},"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.","12-week intervention period",{"measure":70,"description":71,"timeFrame":51},"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).","ALL","15 Years","25 Years",false,{"inclusion":77,"exclusion":84,"raw_text":86},[78,79,80,81,82,83],"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\u002For at least one adherence barrier.",[85],"Cognitive impairments that would limit ability to complete measures, determined by the medical team","Inclusion Criteria:\n\n* 15-25 years old\n* Diagnosed with acute lymphoblastic leukemia (ALL)\n* Taking 6-mercpatopurine (6-MP) as part of their maintenance treatment with at least 6-months remaining\n* Be able to speak and read English\n* Have at least one active social media account (e.g., Instagram, TikTok) or be willing to download a platform for the study\n* Endorse missing a 6-MP dose in the prior month and\u002For at least one adherence barrier.\n\nExclusion Criteria:\n\n* Cognitive impairments that would limit ability to complete measures, determined by the medical team\n* Absence of inclusion criteria above.",[88,89],"CHILD","ADULT",[91,108,119,133],{"facility":92,"city":93,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":105},"Ann & Robert H. Lurie Children's Hospital of Chicago","Chicago","Illinois","60611","United States",[98,103],{"name":99,"role":100,"phone":101,"email":102},"Alexandra Psihogios, Ph.D.","CONTACT","2409946546","apsihogios@luriechildrens.org",{"name":99,"role":104},"PRINCIPAL_INVESTIGATOR",{"lat":106,"lon":107},41.85003,-87.65005,{"facility":13,"city":93,"state":94,"zip":95,"country":96,"contacts":109,"geoPoint":118},[110,113,116],{"name":99,"role":100,"phone":111,"email":112},"240-994-6546","alex.psihogios@northwestern.edu",{"name":114,"role":115},"Alexandra Psihogos, PhD","SUB_INVESTIGATOR",{"name":117,"role":104},"Betina Yanez, Ph.D.",{"lat":106,"lon":107},{"facility":120,"city":121,"state":122,"zip":123,"country":96,"contacts":124,"geoPoint":130},"The Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",[125,129],{"name":126,"role":100,"phone":127,"email":128},"Lisa Schwartz, PhD","267-426-0355","schwartzl@chop.edu",{"name":126,"role":104},{"lat":131,"lon":132},39.95238,-75.16362,{"facility":134,"city":135,"state":136,"zip":137,"country":96,"contacts":138,"geoPoint":144},"MD Anderson Cancer Center","Houston","Texas","77030",[139,143],{"name":140,"role":100,"phone":141,"email":142},"Michael Roth, MD","1-877-632-6789","MRoth1@MDAnderson.org",{"name":140,"role":104},{"lat":145,"lon":146},29.76328,-95.36327,[148],{"name":99,"role":100,"phone":111,"email":112},[],[151,155,158,161],{"pmid":152,"type":153,"citation":154},"36602026","BACKGROUND","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\u002Fpbc.30186. Epub 2023 Jan 5.",{"pmid":156,"type":153,"citation":157},"40346736","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\u002Fpbc.31756. Epub 2025 May 9.",{"pmid":159,"type":153,"citation":160},"22564992","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\u002FJCO.2011.38.9924. Epub 2012 May 7.",{"pmid":162,"type":153,"citation":163},"38408282","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\u002FOP.23.00449. Epub 2024 Feb 26. No abstract available.",[],{"nct_id":4,"conditions":166,"biomarkers":168},[167],"Acute Lymphoblastic Leukemia",[],{"nct_id":4,"found":15,"summary":170,"prompt_version":180},{"design":171,"status":172,"heading":173,"summary":174,"follow_up":175,"word_count":176,"commitments":177,"compensation":178,"drugs_mentioned":179},"This interventional study plans to include 200 participants aged 15-25. It will compare an educational website and social media messages to see their impact on medication adherence.","completed","The AYA Oncology Self-care Movement for ALL","This study is looking at how social media can help young people (ages 15-25) with acute lymphoblastic leukemia (ALL) remember to take their 6-mercaptopurine (a chemotherapy medicine). You could join if you have ALL, are taking 6-mercaptopurine, and have at least six months left of this treatment. You also need to speak and read English and have an active social media account. The study will test an educational website and social media messages (#AYAOSM) designed to improve how well you take your medicine. We'll know if the interventions are successful by tracking how consistently you take your medicine over six months.","Your medication adherence will be monitored for six months.",101,"You will complete a baseline questionnaire online and use an electronic monitor to track your 6-mercaptopurine adherence daily for six months. There will also be a 28-day run-in period where only adherence is monitored.","Not stated in the trial record.",[39,42],"v2"]