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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Tailored Program
BehavioralParticipants 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)
BehavioralParticipants will receive weekly text messages with feedback about their adherence and guidance for requesting additional support if desired
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
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.
Healthcare Utilization
Number of oncology visits, lab draws, ED visits, and hospitalizations
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