N/A
N=24
A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer
Cancer · Adherence, Medication
Bottom Line
View on ClinicalTrials.gov: NCT05706610 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Enrollment Rate — 70 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tailored Program (Behavioral); Feedback Program (Behavioral)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enrollment Rate |
70 | — |
| SECONDARY Retention Rate |
56 | — |
| SECONDARY Intervention Fidelity: Contact |
10 | — |
| SECONDARY Intervention Fidelity: Length |
8 | — |
| SECONDARY Intervention Fidelity: Duration |
10 | — |
| SECONDARY Intervention Fidelity: Content |
12 | — |
| SECONDARY Assessment Completion |
12; 12 | — |
| SECONDARY System Usability Scale |
80.42; 81.25 | — |
| SECONDARY "Adjective Rating Scale" (Measure of Usability) |
5.92; 5.75 | — |
| SECONDARY Number of Participants Rating Behavioral Treatment Acceptability as 4 or Greater |
11; 8 | — |
| SECONDARY Medical Adherence Measure |
97.62; 90.28 | — |
| SECONDARY Electronically Monitored Medication Adherence |
85.44; 63.25 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05706610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.