Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
Conditions
Keywords
Adherence, Adolescent, Young Adult, Mobile Health, Oncology
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.
Detailed description
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).
Interventions
BEHAVIORALADAPTS (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.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Difficulties | 28-day intervention period | Number of technical glitches and errors experienced in implementing the intervention |
| Retention Rate | 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 | Up to 12 months | Number of AYA patients (and matched caregivers) referred and screened for the study |
| Intervention Engagement | 28-day intervention period | Number of 1) viewed and 2) acknowledged micro-randomized text messages |
| Recruitment Rate | 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 | 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). |
Countries
United States
Contacts
CONTACTAlexandra M Psihogios, Ph.D.
PRINCIPAL_INVESTIGATORAlexandra M Psihogios, Ph.D.
Northwestern University
Outcome results
None listed