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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03932903
Recruitment Status Not yet recruiting
First Posted May 1, 2019
Last update posted May 6, 2020
This is a small-scale micro-randomized clinical trial of a new mobile just-in-time adaptive intervention (JITAI) designed to promote oral chemotherapy adherence in adolescents and young adults (AYA) with acute lymphoblastic leukemia (ALL). The goals of this study are to determine intervention feasibility and acceptability.
This is a 28-day micro-randomized pilot trial (i.e., a sequential factorial design) of a just-in-time adaptive intervention (JITAI) called AYA ADAPTS (ADherence Assessments and Personalized Timely Support). AYA ADAPTS is an app that integrate contextually-tailored mobile messages designed to promote oral chemotherapy adherence. Participants in the study will electronically-monitor 6MP adherence with MEMS TrackCaps and complete short ecological momentary assessment (EMA) surveys each afternoon, at the same time prior to the evening 6MP dose, for the 28-day period. AYA ADAPTS will deliver contextually-tailored text messages triggered based on EMA responses (e.g., based on fatigue, mood) and objective data (e.g., time of day, weekend vs. weekday). After receiving a contextually-tailored message, AYA will be asked to acknowledge receipt of the message by pressing a "thumbs up" or "thumbs down" button, to indicate whether or not they liked the message, or a "snooze" button indicating that it was not a good time to receive the message. Following the 28-day intervention period, MEMS TrackCaps will be returned and downloaded during the clinic appointment. AYA will complete a brief acceptability survey electronically via REDCAP, rating AYA ADAPTS on a 5-point Likert scale to assess satisfaction, perceived appropriateness, perceive positive effects, perceived demands, and potential for future use. Exit interviews will also be conducted, audio-recorded, and transcribed to further assess acceptability. For feasibility, the following variables will be tracked: (1) screening rates, (2) recruitment rates, (3) % acknowledged micro-randomized messages, (4) technical difficulties (e.g., micro-randomized messages received when intended), (5) retention rates, and (6) completed assessments (EMA, MEMS, post-measures).
|Experimental: Contextually-tailored Mobile Messages for Adherence
All participants will be micro-randomized to receive contextually-tailored mobile messages designed to promote their oral chemotherapy adherence, with a 60% probability of receiving a contextually-tailored message each day.
Behavioral: AYA ADAPTS (ADherence Assessments and Personalized Timely Support).
AYA ADAPTS is a mobile app intervention that integrates contextually-tailored mobile messages and decision rules about when to deliver the messages, with the ultimate goal of improving oral chemotherapy adherence in adolescents and young adults with acute lymphoblastic leukemia. Each participant will be micro-randomized to receive messages on some days that are adapted to their current characteristics (e.g., mood, pain, location) and designed to promote adherence, and no messages (no intervention) on other days.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Ages 15-25
- Diagnosed with acute lymphoblastic leukemia (ALL)
- In the maintenance phase, completed at least one cycle and has at least one month of
maintenance therapy remaining
- Prescribed 6-mercaptopurine (6MP)
- Self-reported 6MP adherence <95% in the past month - English language proficiency - For AYA <18, must have informed consent from their caregiver. Exclusion Criteria: - Cognitive impairments that would limit ability to complete measures, determined by the medical team - Absence of inclusion criteria above.
Contact: Alexandra M Psihogios, Ph.D. 267-314-0164 email@example.com
Children's Hospital of Philadelphia
Principal Investigator: Alexandra M Psihogios, Ph.D. Children's Hospital of Philadelphia
Study Chair: Lamia P Barakat, Ph.D. Children's Hospital of Philadelphia
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