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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03932903

Recruitment Status Not yet recruiting

First Posted May 1, 2019

Last update posted May 6, 2020

Study Description

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.

  • Condition or Disease:Acute Lymphoblastic Leukemia
  • Intervention/Treatment: Behavioral: AYA ADAPTS (ADherence Assessments and Personalized Timely Support).
  • Phase: N/A
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 AYA ADAPTS (ADherence Assessments and Personalized Timely Support). AYA 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 MEMS TrackCaps 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. AYA 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, MEMS TrackCaps will be returned and downloaded during the clinic appointment. AYA will complete a brief acceptability survey electronically via REDCAP, rating AYA 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, MEMS, post-measures).

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 30 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: This is a 28-day micro-randomized pilot trial (i.e., a sequential factorial design) of a just-in-time adaptive intervention called AYA ADAPTS (Adherence Assessments and Personalized Timely Support). AYA ADAPTS is an app that will deliver contextually-tailored mobile messages (adapted to AYA's current states, such as mood, pain, and location) designed to promote oral chemotherapy adherence. Each AYA in the study (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).
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Supportive Care
  • Official Title: Using Real Time Mobile Health Approaches to Understand and Promote Oral Chemotherapy Adherence in Adolescents and Young Adults With Leukemia
  • Estimated Study Start Date: July 2022
  • Estimated Primary Completion Date: October 2023
  • Estimated Study Completion Date: June 2024
Arms and interventions
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.
Outcome Measures
  • Primary Outcome Measures: 1. Screening Rate [ Time Frame: Up to 12 months ]
    Number of AYA patients referred and screened per month
  • 2. Recruitment Rate [ Time Frame: Up to 12 months ]
    Number of AYA patients enrolled in the study per month
  • 3. 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
  • 4. Intervention Engagement [ Time Frame: 28-day intervention period ]
    Number of acknowledged micro-randomized text messages; categorized by "thumbs up", "thumbs down", and "snooze" responses
  • 5. Technical Difficulties [ Time Frame: 28-day intervention period ]
    Number of technical glitches and errors experienced in implementing the intervention
  • 6. Intervention Satisfaction [ Time Frame: At completion of 28-day intervention ]
    5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely)
  • 7. 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)
  • 8. 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)
  • 9. 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)
  • 10. 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)
Eligibility Criteria
  • Ages Eligible for Study: 15 to 25 Years (Child, Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Ages 15-25

- Diagnosed with acute lymphoblastic leukemia (ALL)

- In the maintenance phase, completed at least one cycle and has at least one month of
maintenance therapy remaining

- Prescribed 6-mercaptopurine (6MP)

- Self-reported 6MP adherence <95% in the past month - 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.

Contacts and Locations
Contacts

Contact: Alexandra M Psihogios, Ph.D. 267-314-0164 psihogiosa@email.chop.edu

Locations
Sponsors and Collaborators

Children's Hospital of Philadelphia

Investigators

Principal Investigator: Alexandra M Psihogios, Ph.D. Children's Hospital of Philadelphia

Study Chair: Lamia P Barakat, Ph.D. Children's Hospital of Philadelphia

More Information