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

Not Applicable

Completed

• Conditions: Adherence, Medication; Cancer
• Interventions: Behavioral: Feedback Program; Behavioral: Tailored Program

• Registration Number: NCT05706610
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-31
• Study Start: 2023-02-23
• Primary Completion: 2024-11-30
• Study Completion: 2025-03-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Patient between 15 and 24 years of age
• Patient diagnosis of cancer
• Patient prescribed oral chemotherapy or prophylactic medication

Exclusion Criteria

• Patient is not fluent in English
• Patient evidences significant cognitive deficits per medical team
• Patient's medical status or treatment precludes participation per medical team, patient, or caregiver
• Patient demonstrates greater than or equal to 95% adherence during run-in period
• Patient declines to use electronic monitoring device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Feedback Program	Feedback Program	8-week feedback program including 8 weekly texts
Tailored Program	Tailored Program	8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins

Primary Outcome Measures

Name	Time	Method
Enrollment Rate	End of study enrollment period, approximately 12 months after enrollment initiation	Percent of approached eligible participants enrolling in the study

Secondary Outcome Measures

Name	Time	Method
Retention Rate	End of data collection period, approximately 18 months after enrollment initiation	Percent of participants completing all procedures
Intervention Fidelity: Contact	End of data collection period, approximately 18 months after enrollment initiation	Percent of enrolled participants who received 4 intervention sessions
Intervention Fidelity: Length	End of data collection period, approximately 18 months after enrollment initiation	Percent of enrolled participants for whom all sessions were 30-45 minutes in length
Acceptability & Adherence Scale	4 weeks following treatment completion	Rating of behavioral treatment acceptability
Assessment Completion	End of data collection period, approximately 18 months after enrollment initiation	Percent of enrolled participants with complete data
Intervention Fidelity: Duration	End of data collection period, approximately 18 months after enrollment initiation	Percent of enrolled participants who completed all 4 intervention sessions during a 8-10 week period
Adjective Rating Scale	4 weeks following treatment completion	1-item rating of user friendliness
Medical Adherence Measure	4 weeks following treatment completion	2-item self-report of missed doses
Electronically Monitored Medication Adherence	Starting 4 weeks prior to treatment initiation and continuing until 4 weeks following treatment completion	Each participant will be given an electronic monitoring device to store their medication. The electronic monitoring device records each time the device is opened.
Intervention Fidelity: Content	End of data collection period, approximately 18 months after enrollment initiation	Percent of enrolled participants who received all of the planned intervention content as defined in the fidelity checklist
System Usability Scale	4 weeks following treatment completion	A 10-item rating of usability

Trial Locations

Locations (3)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

St Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States