Children's Hospital Medical Center, Cincinnati
A pilot feasibility randomized clinical trial comparing a tailored intervention to uniform standard of care will be conducted. A total of 40 AYAs with cancer will be randomized to one of the two programs. Data will be collected to explore the hypotheses that the intervention meets pre-established enrollment, retention, fidelity, and data completion feasibility criteria and that AYAs will rate the intervention as easy to use and acceptable.
Cancer
Adherence, Medication
Tailored Program
Feedback Program
Not Applicable
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. Up to 40 adolescents and young adults (AYAs) with cancer will be enrolled in this study. Participants who enroll in this trial will be given an eCAP electronic monitor, a pill bottle with a computer chip in the cap, to store their medication. After using the electronic monitor for 4 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 either the tailored adherence-promotion intervention group (Tailored Program) or the uniform standard of care group (Feedback Program). Participants will be assigned in a 1:1 ratio so that, at the end of the study, an equal number of participants will have been randomized to each group. Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and 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 including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired. 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 post-treatment questionnaires regarding program usability and acceptability as well as their adherence.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 40 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Treatment |
| Official Title : | A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer |
| Actual Study Start Date : | February 23, 2023 |
| Estimated Primary Completion Date : | November 30, 2024 |
| Estimated Study Completion Date : | November 30, 2024 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Tailored Program 8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins |
Behavioral: Tailored Program |
|
Other: Feedback Program 8-week feedback program including 8 weekly texts |
Behavioral: Feedback Program |
| Ages Eligible for Study: | 15 Years to 24 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
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