A Tailored Medication Adherence-Promotion Intervention for Adolescents and Young Adults With Cancer

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

Study Overview

• Status: Recruiting
• Conditions: Cancer; Medication Adherence
• Intervention / Treatment: Behavioral: Tailored Program; Behavioral: Feedback Program (Uniform Standard of Care)

Detailed Description

The proposed research includes a randomized clinical trial of a tailored adherence-promotion intervention (Tailored Program) as compared to uniform standard of care (Feedback Program) for adolescents and young adults with cancer. As part of this study, up to 160 adolescents and young adults (AYAs) with cancer will be randomized to one of these groups. Participants who enroll in this trial will be given an electronic pill bottle or box with a computer chip to store their medication. After using the electronic monitor for a few weeks to assess baseline adherence, participants who demonstrate non-adherence and have used the electronic monitor without difficulty will be asked to complete pre-treatment questionnaires. Next, participants will be randomly assigned to one of the two groups and complete their assigned program. Adolescents and young adults will continue to use the electronic monitor to store their medication until approximately a month after their program ends. After their program ends, participants will complete questionnaires at post-treatment and again about 6 months later.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meghan E. McGrady, PhD; Phone Number: 513-803-8044; Email: Meghan.McGrady@cchmc.org

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Not yet recruiting
      • The University of Kansas Medical Center
      • Contact: Carolyn Bates, PhD; Email: cbates4@kumc.edu
  • New York
    • New York, New York, United States, 1003230702
      • Not yet recruiting
      • Columbia University Irving Medical Center
      • Contact: Melissa Beauchemin, PhD; Email: mmp2123@cumc.columbia.edu
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Meghan E McGrady, PhD; Phone Number: 513-803-8044; Email: Meghan.McGrady@cchmc.org
  • Washington
    • Seattle, Washington, United States, 98105
      • Not yet recruiting
      • Seattle Children's Hospital
      • Contact: Tyler Ketterl, MD; Email: Tyler.Ketterl@seattlechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tailored Program; 8-week program including 4 coach visits and 4 text check-ins	Behavioral: 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.
Other: Feedback Program (Uniform Standard of Care); 8-week feedback program including weekly texts	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (Mental Health)	PROMIS (Patient-Reported Outcomes Measurement Information System) Global Mental Health 2a. Raw score range = 2-10. Higher scores = better quality of life.	Approximately 1 month after completing one of the study programs
Quality of Life (Physical Health)	PROMIS (Patient-Reported Outcomes Measurement Information System) Global Physical Health 2a. Raw score range = 2-10. Higher scores = better quality of life.	Approximately 1 month after completing one of the study programs
Healthcare Utilization	Number of oncology visits, lab draws, ED visits, and hospitalizations	6 months post-treatment

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: National Cancer Institute (NCI); Columbia University; Seattle Children's Hospital; University of Kansas Medical Center
• Investigators: Principal Investigator: Meghan E. McGrady, PhD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2026
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): August 31, 2030

Study Registration Dates

• First Submitted: October 28, 2025
• First Submitted That Met QC Criteria: October 30, 2025
• First Posted (Actual): October 31, 2025

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: cancer; adherence; adolescents and young adults
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Neoplasms; Medication Adherence
• Other Study ID Numbers: R37CA302422 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No