Mobile Health Intervention to Support Oral Chemotherapy Adherence in Adolescents and Young Adults With Leukemia

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a 28-day micro-randomized pilot trial (i.e., a sequential factorial design) of a just-in-time adaptive intervention (JITAI) called ADAPTS (ADherence Assessments and Personalized Timely Support). 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 eCAPs 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. 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, eCAPS will be returned and downloaded during the clinic appointment. AYA will complete a brief acceptability survey electronically via REDCAP, rating 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, eCAPS, post-measures).

Official Title
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Using Real Time Mobile Health Approaches to Understand and Promote Oral Chemotherapy Adherence in Adolescents and Young Adults With Leukemia

Conditions
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Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Behavioral: AYA ADAPTS (ADherence Assessments and Personalized Timely Support).


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 14-29 Diagnosed with acute lymphoblastic leukemia (ALL) or lymphoma In the maintenance phase, completed at least one cycle and has at least one month of maintenance therapy remaining Prescribed 6-mercaptopurine (6MP) 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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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 ADAPTS (Adherence Assessments and Personalized Timely Support). 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contextually-tailored Mobile Messages for Adherence<br>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).<br>* 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.<br>|
| No Intervention: No messages<br>All participants will also be micro-randomized to not receive messages on some days of the intervention ( 40% of the time). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening Rate | Number of AYA patients referred and screened per month | Up to 12 months | 
| Recruitment Rate | Number of AYA patients enrolled in the study per month | Up to 12 months | 
| Retention Rate | Number of AYA subjects who complete the intervention, out of the total number of AYA subjects enrolled in the study | Up to 12 months | 
| Intervention Engagement | Number of acknowledged micro-randomized text messages; categorized by thumbs up, thumbs down, and snooze responses | 28-day intervention period | 
| Technical Difficulties | Number of technical glitches and errors experienced in implementing the intervention | 28-day intervention period | 
| Intervention Satisfaction | 5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely) | At completion of 28-day intervention | 
| Intervention Perceived Appropriateness | 5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely) | At completion of 28-day intervention | 
| Intervention Perceived Positive Effects | 5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely) | At completion of 28-day intervention | 
| Intervention Perceived Demands | 5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely) | At completion of 28-day intervention | 
| Potential for Intervention Future Use | 5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely) | At completion of 28-day intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Adolescent, Young Adult, Mobile Health, Oncology