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

November 1, 2023 updated by: Alex Psihogios, Northwestern University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Contextually-tailored Mobile Messages for Adherence
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).
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.
No Intervention: No messages
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?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Alexandra M Psihogios, Ph.D., Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

April 24, 2019

First Submitted That Met QC Criteria

April 29, 2019

First Posted (Actual)

May 1, 2019

Study Record Updates

Last Update Posted (Estimated)

November 3, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-016325

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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