Clinical trial NCT06989489: Implementation of an Oral Chemotherapy Adherence Intervention
Official title: Design and Implementation of a Social Cognitive Theory-based Medication Adherence Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Solid Tumor
Hematologic Malignancy
Keywords: oral anticancer agent
oral chemotherapy
adherence
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-05-25
Enrollment: 160
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Surveys will be administered to two different groups, before implementation and after implementation of intervention.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to evaluate the effectiveness and usability of a newly developed oral anticancer agent adherence program implemented across 6 cancer clinics (two academic, two urban, and two rural). The study will include 160 adult participants with either solid tumors or hematologic malignancies who have been taking oral anticancer agents for at least six months.

This study will have two groups of participants, a pre- and post-implementation group. In the pre-implementation of the program group, investigators will administer a survey to the 80 participants and gather information about their medication prior to their enrollment of the program. Similarly, 80 participants who have been enrolled into this program for at least 6 months will serve as the post-implementation group. These patients will be administered the same survey. The results from both groups will be analyzed to see how effective the medication adherence program is.

Detailed description: Participants enrolled in this adherence program will have individualized counseling sessions with their clinical pharmacists regarding their oral anticancer agent. The pharmacists will review with all their patients, information including proper administration, side effects, symptom management, and treatment plans. Participants will continue to have these counseling sessions with their pharmacists, until the patient becomes stable on the oral anticancer agent.

Once stable, the participant will be placed into one of three monitoring risk categories (low risk, medium risk, high risk), by the pharmacist, based on several factors. Each of the three monitor categories will have different monitoring intervals where patients will interact with the pharmacists differently. Additionally, each patient will have follow-up appointments and will have access to further education and will be reassessed each time. Furthermore, additional help will be provided to each patient based on their needs. Depending on the monitoring category, participants may meet with their pharmacist more and communicate either through electronic surveys or in-person visits.

Eligibility 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

Primary outcomes:
measure: Oral Medication Adherence
timeFrame: Baseline and week 4
measure: Acceptability
timeFrame: After 6 months
measure: Appropriateness
timeFrame: After 6 months
measure: Everyday use
timeFrame: After 6 months
Secondary outcomes:
measure: Medication knowledge
timeFrame: Baseline and 4 weeks
measure: Patient perception
timeFrame: Baseline and 4 weeks
measure: Health literacy
timeFrame: Baseline and 4 weeks
measure: Self-efficacy
timeFrame: Baseline and 4 weeks
measure: Patient satisfaction
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Benyam Muluneh, PharmD
role: PRINCIPAL_INVESTIGATOR
References: