Pharmacist-led program to help patients take oral cancer medicines as prescribed
Design and Implementation of a Social Cognitive Theory-based Medication Adherence Intervention
This program will test whether pharmacist counseling and risk-based monitoring helps adults with solid tumors or blood cancers who have been on oral cancer medicines for at least six months take their medication more consistently.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06989489 on ClinicalTrials.gov |
What this trial studies
The program pairs patients with clinical pharmacists who provide individualized counseling on how to take oral anticancer agents, manage side effects, and follow treatment plans. After stabilization, pharmacists assign patients to low, medium, or high monitoring categories with different follow-up intervals and communication methods, including electronic surveys or in-person visits. The study compares outcomes from 80 patients before the program was implemented to 80 patients who have been in the program for at least six months across six clinics (academic, urban, and rural). Results will examine usability and changes in adherence and related patient outcomes.
Who should consider this trial
Good fit: Adults aged 21 or older with a solid tumor or hematologic malignancy who have been on a single-agent oral anticancer medication continuously for at least six months are ideal candidates.
Not a fit: Patients on time-limited or intermittent (non-continuous) therapy, those receiving comfort or hospice care, or patients newly starting oral therapy (under six months) are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could increase medication adherence, reduce side-effect-related problems, and improve treatment continuity for patients on oral anticancer agents.
How similar studies have performed: Previous pharmacist-led adherence interventions for oral oncology and other chronic medications have shown improvements in adherence, though large multi-site implementation data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (age ≥21 years-old) patients * Diagnosed with a solid or hematologic malignancy * Monotherapy on oral anticancer agent on treatment for at least 6 months Exclusion criteria: * Patients on time-limited or intermittent therapy (non-continuous) * Patients on comfort (end-of-life) care * Patients enrolled on hospice
Where this trial is running
Chapel Hill, North Carolina
- UNC Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Benyam Muluneh, PharmD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Solomon Ayehu, MD
- Email: solsay@unc.edu
- Phone: 9196722032
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.