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

NCT ID: NCT07223463

Last Updated: 2025-10-31

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2030-08-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Cancer Medication Adherence

Keywords

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adolescents and young adults cancer adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Tailored Program

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

Group Type EXPERIMENTAL

Tailored Program

Intervention Type BEHAVIORAL

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

Group Type OTHER

Feedback Program (Uniform Standard of Care)

Intervention Type BEHAVIORAL

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.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Seattle Children's Hospital

OTHER

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Columbia University Irving Medical Center

New York, New York, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Seattle Children's Hospital

Seattle, Washington, United States

Site Status

Countries

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United States

Central Contacts

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Meghan E. McGrady, PhD

Role: CONTACT

Phone: 513-803-8044

Email: [email protected]

Facility Contacts

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Carolyn Bates, PhD

Role: primary

Melissa Beauchemin, PhD

Role: primary

Other Identifiers

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R37CA302422

Identifier Type: NIH

Identifier Source: secondary_id

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R37CA302422

Identifier Type: NIH

Identifier Source: org_study_id

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