Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Acute Lymphoblastic Leukemia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a 28-day micro-randomized pilot trial (i.e., a sequential factorial design) of a just-in-time adaptive intervention called AYA ADAPTS (Adherence Assessments and Personalized Timely Support). AYA ADAPTS is an app that will deliver contextually-tailored mobile messages (adapted to AYA's current states, such as mood, pain, and location) designed to promote oral chemotherapy adherence. Each AYA in the study (n=30) will be micro-randomized (with a 60% probability) to receive a contextually-tailored message each day that supports abilities to self-manage and maintain adherence, delivered prior to their scheduled dose, over a 28-day period (i.e., the period between follow-up appointments). The remaining 40% of days, participants will be assigned to receive no messages (i.e., no intervention).Masking: Double (Participant, Investigator)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 15 years and 25 years
Gender
Both males and females

Description

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...

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).

Tracking Information

NCT #
NCT03932903
Collaborators
Not Provided
Investigators
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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