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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-24
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tailored Program

    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)

    Behavioral

    Participants will receive weekly text messages with feedback about their adherence and guidance for requesting additional support if desired

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Tailored ProgramExperimental treatment 1 intervention
Group B: Feedback Program (Uniform Standard of Care)Other 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
The 1-month period following the completion of one of the study programs.

Secondary outcomes

1

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.

Time frame
Approximately 1 month after completing one of the study programs
2

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.

Time frame
Approximately 1 month after completing one of the study programs
3

Healthcare Utilization

Number of oncology visits, lab draws, ED visits, and hospitalizations

Time frame
6 months post-treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Medical Center, Cincinnati

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Seattle Children's Hospital

Collaborator

University of Kansas Medical Center

Collaborator

Columbia University

Collaborator