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

Acute Lymphoblastic Leukemia Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

• NCT number: NCT03932903
• Study type: Interventional
• Source: Northwestern University
• Contact: Alexandra M Psihogios, Ph.D.
• Phone: 240-994-6546
• Email: alex.psihogios@northwestern.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Completion date: August 31, 2024