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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05706610.
Locations matching your search criteria
United States
Tennessee
Memphis
Saint Jude Children's Research HospitalStatus: Active
Name Not Available
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.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationCincinnati Children's Hospital Medical Center
