Clinical trial · Interventional
A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer
NCT05706610CI-TRIAL-00098205completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adherence, Medication | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Feedback Program | Behavioral | — | UNRESOLVED |
| Tailored Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tailored Program
- description
- 8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins
- interventionNames
- Behavioral: Tailored Program
- type
- OTHER
- label
- Feedback Program
- description
- 8-week feedback program including 8 weekly texts
- interventionNames
- Behavioral: Feedback Program
Primary outcomes (1)
- measure
- Enrollment Rate
- timeFrame
- End of study enrollment period, approximately 12 months after enrollment initiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 24 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDMcGrady ME, Ketterl TG, Webster RT, Burns MMK, Bills SE, Burke M, Szulczewski L, Brock MY, Schwartz LE, Herriott JK, Hommel KA, Pai ALH, Mara CA, Norris RE. Feasibility Trial of a Tailored Adherence-Promotion Intervention for Adolescents and Young Adults With Cancer. Pediatr Blood Cancer. 2026 Jan;73(1):e32127. doi: 10.1002/pbc.32127. Epub 2025 Oct 27. PMID 41146444
- DERIVEDMcGrady ME, Ketterl TG, Webster RT, Schwartz LE, Brock MY, Szulczewski L, Burke M, Hommel KA, Pai ALH, Mara CA, Steele AC, Regan GG, Norris RE. Feasibility pilot trial of a tailored medication adherence-promotion intervention for adolescents and young adults with cancer: Study design and protocol. Contemp Clin Trials. 2024 Apr;139:107483. doi: 10.1016/j.cct.2024.107483. Epub 2024 Feb 29. PMID 38431133