Implementation of an Oral Chemotherapy Adherence Intervention

UNC Lineberger Comprehensive Cancer Center

Status: Enrolling

Conditions: Hematologic Malignancy; Solid Tumor

Treatments: Behavioral: Multilevel Adherence Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06989489

K08CA279500 (U.S. NIH Grant/Contract)

LCCC2125-AIM3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Standard of Care patients

No Intervention group

Description:

Clinical pharmacists will follow their specific standards of procedure when educating patients on oral anticancer agents. No longitudinal following or tailored patient support will be provided. This group of participants will serve as the control group of the study.

Intervention participants

Experimental group

Description:

Participants enrolled in this adherence program will have individualized counseling sessions with their clinical pharmacists regarding their oral anticancer agent. Participants will be followed longitudinally and will receive tailored support.

Treatment:

Behavioral: Multilevel Adherence Intervention