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

Not Applicable

Not yet recruiting

• Conditions: Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma
• Interventions: Behavioral: ADAPTS (ADherence Assessments and Personalized Timely Support).

• Registration Number: NCT03932903
• Lead Sponsor: Northwestern University

Brief Summary

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

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).

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-04-29
• Study First Posted: 2019-05-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02
• Study Start: 2024-10-01
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

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Exclusion Criteria

• Cognitive impairments that would limit ability to complete measures, determined by the medical team
• Absence of inclusion criteria above.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contextually-tailored Mobile Messages for Adherence	ADAPTS (ADherence Assessments and Personalized Timely Support).	AYA 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.

Primary Outcome Measures

Name	Time	Method
Technical Difficulties	28-day intervention period	Number of technical glitches and errors experienced in implementing the intervention
Retention Rate	Up to 12 months	Number of AYA (and caregiver) subjects who complete the intervention, out of the total number of subjects enrolled in the study (target of 75% or more)
Screening Rate	Up to 12 months	Number of AYA patients (and matched caregivers) referred and screened for the study
Intervention Engagement	28-day intervention period	Number of 1) viewed and 2) acknowledged micro-randomized text messages
Recruitment Rate	Up to 12 months	Number of AYA patients (and matched caregivers) enrolled in the study out of those who were eligible and invited to participate (target of 75% or more)
Intervention Acceptability	At completion of 28-day intervention period	5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely) to rate intervention acceptability (including satisfaction, appropriateness, perceived positive effects, potential for future use).