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

8-week feedback program including 8 weekly texts

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.

Tailored Program

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.

Feedback Program

Meghan E McGrady, PhD

Rachel Tillery Webster, PhD

Tyler Ketterl, MD

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.

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.

A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer

Percent of approached eligible participants enrolling in the study

Percent of participants completing all procedures

Percent of enrolled participants who received 4 intervention sessions

Percent of enrolled participants for whom all sessions were 30-45 minutes in length

Percent of enrolled participants who completed all 4 intervention sessions during a 8-10 week period

Percent of enrolled participants who received all of the planned intervention content as defined in the fidelity checklist

Percent of enrolled participants with complete data

Rating of behavioral treatment acceptability

Each participant will be given an electronic monitoring device to store their medication. The electronic monitoring device records each time the device is opened.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer	NCT05706610	Cancer Adherence, Medi...	Tailored Progra... Feedback Progra...	15 Years - 24 Years	Children's Hospital Medical Center, Cincinnati
A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer	NCT05706610	Cancer Adherence, Medi...	Tailored Progra... Feedback Progra...	15 Years - 24 Years	Children's Hospital Medical Center, Cincinnati

Spots Global Cancer Trial Database for feedback program