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

NCT03932903 | Recruiting

• 1 other identifier: 19-016325
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma

Keywords

Adherence; Adolescent; Young Adult; Mobile Health; Oncology

Outcome Measures

Primary Outcomes (6)

• Technical Difficulties

  Number of technical glitches and errors experienced in implementing the intervention

  28-day intervention period

• Retention Rate

  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)

  Up to 12 months

• Screening Rate

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

  Up to 12 months

• Intervention Engagement

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

  28-day intervention period

• Recruitment Rate

  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)

  Up to 12 months

• Intervention Acceptability

  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).

  At completion of 28-day intervention period

Study Arms (2)

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.

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

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).

Interventions

ADAPTS (ADherence Assessments and Personalized Timely Support). BEHAVIORAL

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 AYAs with acute lymphoblastic leukemia and lymphoma. AYA participants 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. Other features in the app include a medication calendar that syncs with the electronic medication monitor (eCAP) to track daily adherence. A caregiver version of ADAPTS is also available, providing daily surveys (but no randomized mobile messages) and the medication calendar so that dyads can mutually track adherence.

Contextually-tailored Mobile Messages for Adherence

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Cognitive impairments that would limit ability to complete measures, determined by the medical team
• Nominated by the AYA as a primary caregiver involved in cancer care (can be a parent, relative, partner, friend)
• English language proficiency

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (8)

• Bhatia S, Landier W, Hageman L, Kim H, Chen Y, Crews KR, Evans WE, Bostrom B, Casillas J, Dickens DS, Maloney KW, Neglia JP, Ravindranath Y, Ritchey AK, Wong FL, Relling MV. 6MP adherence in a multiracial cohort of children with acute lymphoblastic leukemia: a Children's Oncology Group study. Blood. 2014 Oct 9;124(15):2345-53. doi: 10.1182/blood-2014-01-552166. Epub 2014 May 14.

  PMID: 24829202 BACKGROUND

• Modi AC, Pai AL, Hommel KA, Hood KK, Cortina S, Hilliard ME, Guilfoyle SM, Gray WN, Drotar D. Pediatric self-management: a framework for research, practice, and policy. Pediatrics. 2012 Feb;129(2):e473-85. doi: 10.1542/peds.2011-1635. Epub 2012 Jan 4.

  PMID: 22218838 BACKGROUND

• Klasnja P, Hekler EB, Shiffman S, Boruvka A, Almirall D, Tewari A, Murphy SA. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015 Dec;34S(0):1220-8. doi: 10.1037/hea0000305.

  PMID: 26651463 BACKGROUND

• Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8.

  PMID: 27663578 BACKGROUND

• Psihogios AM, Li Y, Butler E, Hamilton J, Daniel LC, Barakat LP, Bonafide CP, Schwartz LA. Text Message Responsivity in a 2-Way Short Message Service Pilot Intervention With Adolescent and Young Adult Survivors of Cancer. JMIR Mhealth Uhealth. 2019 Apr 18;7(4):e12547. doi: 10.2196/12547.

  PMID: 30998225 BACKGROUND

• Psihogios AM, Fellmeth H, Schwartz LA, Barakat LP. Family Functioning and Medical Adherence Across Children and Adolescents With Chronic Health Conditions: A Meta-Analysis. J Pediatr Psychol. 2019 Jan 1;44(1):84-97. doi: 10.1093/jpepsy/jsy044.

  PMID: 29982694 BACKGROUND

• McGrady ME, Brown GA, Pai AL. Medication adherence decision-making among adolescents and young adults with cancer. Eur J Oncol Nurs. 2016 Feb;20:207-14. doi: 10.1016/j.ejon.2015.08.007. Epub 2015 Sep 12.

  PMID: 26372619 BACKGROUND

• Butow P, Palmer S, Pai A, Goodenough B, Luckett T, King M. Review of adherence-related issues in adolescents and young adults with cancer. J Clin Oncol. 2010 Nov 10;28(32):4800-9. doi: 10.1200/JCO.2009.22.2802. Epub 2010 Mar 8.

  PMID: 20212260 BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Alexandra M Psihogios, Ph.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra M Psihogios, Ph.D.

CONTACT

312-503-3577; alex.psihogios@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study involve a 28-day micro-randomized pilot trial (i.e., a sequential factorial design) of a just-in-time adaptive intervention called ADAPTS ADAPTS is an app that will deliver contextually-tailored mobile messages (adapted to current states, such as mood, pain, and location) designed to promote oral chemotherapy adherence. Each AYA in the study (planned 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). We will also request, but not require, that a caregiver enrolls in the study and pilots the caregiver version of the app (planned n=30 caregivers). The caregiver app does not include any micro-randomization.

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 1, 2019
• Study Start: July 31, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)