A Tailored Medication Adherence-Promotion Intervention for Adolescents and Young Adults With Cancer
1 other identifier
interventional
160
1 country
4
Brief Summary
The goal of this clinical trial is to learn if a tailored intervention can help make it easier for adolescents and young adults with cancer to take their medications. The main questions the researchers are trying to answer are:
- Does the tailored intervention increase adherence?
- Does the tailored intervention improve quality of life?
- Does the tailored intervention reduce health care utilization? The researchers will compare the tailored intervention to a uniform standard of care intervention (an intervention designed to be similar to what is currently happening in clinical care) to see if the tailored intervention works to improve adherence. Participants will:
- Use an electronic pill bottle or box to store their medication
- Participate in intervention sessions
- Complete surveys before the intervention, after the intervention, and 6-months later
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Mar 2026
Longer than P75 for not_applicable cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2025
CompletedFirst Posted
Study publicly available on registry
October 31, 2025
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2030
October 31, 2025
October 1, 2025
3.8 years
October 28, 2025
October 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medication Adherence
Each participant will be given an electronic adherence monitoring device to store their medication. An electronic adherence monitoring device is a pill bottle or box with an embedded computer chip. The computer chip records each time the device is opened. These device openings, or actuations, will be compared with the patient's prescribed medication regimen to compute their adherence (defined as the percentage of doses taken as prescribed).
The 1-month period following the completion of one of the study programs.
Secondary Outcomes (3)
Quality of Life (Mental Health)
Approximately 1 month after completing one of the study programs
Quality of Life (Physical Health)
Approximately 1 month after completing one of the study programs
Healthcare Utilization
6 months post-treatment
Study Arms (2)
Tailored Program
EXPERIMENTAL8-week program including 4 coach visits and 4 text check-ins
Feedback Program (Uniform Standard of Care)
OTHER8-week feedback program including weekly texts
Interventions
Participants will participate in 4 sessions with a coach, 1 every other week. During these sessions, the participant will work with their coach to identify a barrier to adherence they would like to target. Then, they will work with their coach to create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text reminder about the plan.
Participants will receive weekly text messages with feedback about their adherence and guidance for requesting additional support if desired
Eligibility Criteria
You may qualify if:
- Patient is 15.00 to 24.99 years of age
- Patient is diagnosed with cancer
- Patient is prescribed an oral anticancer/antitumor agent or prophylaxis
You may not qualify if:
- Patient is not fluent in English
- Patient evidences significant cognitive deficits
- Patient's medical status or treatment precludes participation
- Patient enrolled on a medical trial requiring medication storage in a trial-provided container
- Patient demonstrates greater than or equal to 95% adherence during run-in period
- Patient declines to use or has difficulty using electronic adherence monitoring device during run-in
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital Medical Center, Cincinnatilead
- National Cancer Institute (NCI)collaborator
- Seattle Children's Hospitalcollaborator
- University of Kansas Medical Centercollaborator
- Columbia Universitycollaborator
Study Sites (4)
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Columbia University Irving Medical Center
New York, New York, 1003230702, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meghan E. McGrady, PhD
Children's Hospital Medical Center, Cincinnati
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2025
First Posted
October 31, 2025
Study Start
March 1, 2026
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
August 1, 2030
Last Updated
October 31, 2025
Record last verified: 2025-10