A Tailored Medication Adherence-Promotion Intervention for Adolescents and Young Adults With Cancer
NCT ID: NCT07223463
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
160 participants
INTERVENTIONAL
2026-03-31
2030-08-31
Brief Summary
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* 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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tailored Program
8-week program including 4 coach visits and 4 text check-ins
Tailored Program
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.
Feedback Program (Uniform Standard of Care)
8-week feedback program including weekly texts
Feedback Program (Uniform Standard of Care)
Participants will receive weekly text messages with feedback about their adherence and guidance for requesting additional support if desired
Interventions
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Tailored Program
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.
Feedback Program (Uniform Standard of Care)
Participants will receive weekly text messages with feedback about their adherence and guidance for requesting additional support if desired
Eligibility Criteria
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Inclusion Criteria
* Patient is diagnosed with cancer
* Patient is prescribed an oral anticancer/antitumor agent or prophylaxis
Exclusion Criteria
* 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
15 Years
24 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Seattle Children's Hospital
OTHER
University of Kansas Medical Center
OTHER
Columbia University
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Meghan E. McGrady, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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The University of Kansas Medical Center
Kansas City, Kansas, United States
Columbia University Irving Medical Center
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Carolyn Bates, PhD
Role: primary
Melissa Beauchemin, PhD
Role: primary