Recruiting

JITAI

Sponsor:

Northwestern University

Code:

NCT03932903

Conditions

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Interventions

ADAPTS (ADherence Assessments and Personalized Timely Support).

Study Details

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

Study ID

NCT03932903

Start date

Jul 31, 2025

Status verified date

Jun, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

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.

AYA Exclusion Criteria:

  • 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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Contextually-tailored Mobile Messages for Adherence

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.

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).

Interventions

ADAPTS (ADherence Assessments and Personalized Timely Support).

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.

Primary outcome measure

  • Technical Difficulties [ Time Frame: 28-day intervention period ]
  • Retention Rate [ Time Frame: Up to 12 months ]
  • Screening Rate [ Time Frame: Up to 12 months ]
  • Intervention Engagement [ Time Frame: 28-day intervention period ]
  • Recruitment Rate [ Time Frame: Up to 12 months ]
  • Intervention Acceptability [ Time Frame: At completion of 28-day intervention period ]

Central Contacts and Locations

Central contacts

Alexandra M Psihogios, Ph.D.

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

Locations

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Alexandra Psihogios, Ph.D.

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

More Information

Sponsor

Northwestern University

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • Adherence
  • Adolescent
  • Young Adult
  • Mobile Health
  • Oncology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-06-30.