Mobile Health Intervention to Support Oral Chemotherapy Adherence in Adolescents and Young Adults With Leukemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorNorthwestern University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Cognitive impairments that would limit ability to complete measures, determined by the medical team
Absence of inclusion criteria above.
Nominated by the AYA as a primary caregiver involved in cancer care (can be a parent, relative, partner, friend)
English language proficiency
Trial design
Design model
Parallel
Treatments tested in this trial
ADAPTS (ADherence Assessments and Personalized Timely Support).
BehavioralADAPTS 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Contextually-tailored Mobile Messages for AdherenceExperimental treatment 1 intervention
Group B: No messagesNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Technical Difficulties
Number of technical glitches and errors experienced in implementing the intervention
Time frame
28-day intervention period2
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)
Time frame
Up to 12 months3
Screening Rate
Number of AYA patients (and matched caregivers) referred and screened for the study
Time frame
Up to 12 months4
Intervention Engagement
Number of 1) viewed and 2) acknowledged micro-randomized text messages
Time frame
28-day intervention periodSponsors and contacts
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Source ClinicalTrials.gov