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

Cincinnati Children's Hospital Medical Center

Status: Begins enrollment this month

Conditions: Medication Adherence; Cancer

Treatments: Behavioral: Tailored Program; Behavioral: Feedback Program (Uniform Standard of Care)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07223463

R37CA302422 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 15 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Tailored Program

Experimental group

Description:

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

Treatment:

Behavioral: Tailored Program

Feedback Program (Uniform Standard of Care)

Other group

Description:

8-week feedback program including weekly texts

Treatment:

Behavioral: Feedback Program (Uniform Standard of Care)