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临床试验/NCT03932903
NCT03932903招募中不适用

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

Northwestern University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Technical Difficulties

研究概览

简要总结

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.

详细描述

This is two-month study involving a 28-day run-in period (no intervention), followed by 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 integrates contextually-tailored mobile messages designed to promote adherence to an oral chemotherapy called 6-mercaptopurine (6-MP). Participants in the study will electronically-monitor 6-MP adherence with eCAPs for 28 days (approximately one month to establish baseline adherence before introducing the intervention). On approximately Day 29, they will download and use the app while continuing to monitor their adherence for the next 28 days. ADAPTS is an app that is available for Android and Apple devices, and has an Adolescent/Young Adult (AYA) version (i.e., the primary user) and a Caregiver version. ADAPTS delivers ecological momentary assessment (EMA) surveys each afternoon to AYAs and caregivers, at the same time prior to the evening 6-MP dose, for the 28-day period. Based on EMA responses, ADAPTS sends contextually-tailored mobile messages to AYAs (e.g., based on self-reported fatigue, mood) and objective data (e.g., weekend vs. weekday). After receiving a contextually-tailored message, AYAs 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. Some features in ADAPTS are designed for AYAs and their caregivers to use together, such as a medication calendar that syncs with the eCAP and can be viewed by both members of the dyad. Following the 28-day intervention period, eCAPS will be returned and downloaded during the clinic appointment. AYAs and caregivers 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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • AYA 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.

排除标准

  • Cognitive impairments that would limit ability to complete measures, determined by the medical team
  • Absence of inclusion criteria above.
  • Caregiver Inclusion Criteria:
  • Nominated by the AYA as a primary caregiver involved in cancer care (can be a parent, relative, partner, friend)
  • English language proficiency
  • Caregiver Exclusion Criteria:
  • - Absence of inclusion criteria above.

研究组 & 干预措施

Contextually-tailored Mobile Messages for Adherence

Experimental

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.

干预措施: ADAPTS (ADherence Assessments and Personalized Timely Support). (Behavioral)

No messages

No Intervention

All participants will also be micro-randomized to not receive messages on some days of the intervention (~40% of the time).

结局指标

主要结局

Technical Difficulties

时间窗: 28-day intervention period

Number of technical glitches and errors experienced in implementing the intervention

Retention Rate

时间窗: 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

时间窗: Up to 12 months

Number of AYA patients (and matched caregivers) referred and screened for the study

Intervention Engagement

时间窗: 28-day intervention period

Number of 1) viewed and 2) acknowledged micro-randomized text messages

Recruitment Rate

时间窗: 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

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alex Psihogios

Assistant Professor

Northwestern University

研究点 (2)

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