Recruiting

Tailored Intervention

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT07223463

Conditions

Cancer

Medication Adherence

Eligibility Criteria

Sex: All

Age: 15 - 24

Healthy Volunteers: Not accepted

Interventions

Tailored Program

Feedback Program (Uniform Standard of Care)

Study Details

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

Conditions

Cancer

Medication Adherence

Study ID

NCT07223463

Start date

Aug 31, 2026

Status verified date

Aug, 2026

Completion date

Aug 31, 2030

Anticipated

Primary completion date

Jan 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 24

Healthy Volunteers: Not accepted

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 Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tailored Program

8-week program including 4 coach visits and 4 text check-ins

other: Feedback Program (Uniform Standard of Care)

8-week feedback program including weekly texts

Interventions

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

Primary outcome measure

  • Medication Adherence [ Time Frame: The 1-month period following the completion of one of the study programs. ]

Central Contacts and Locations

Central contacts

Meghan E. McGrady, PhD

513-803-8044Meghan.McGrady@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Meghan E McGrady, PhD

513-803-8044Meghan.McGrady@cchmc.org

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • adolescents and young adults
  • cancer
  • adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-09-01.