Implementation of an Oral Chemotherapy Adherence Intervention

Not Applicable

Not yet recruiting

• Conditions: Solid Tumor; Hematologic Malignancy

• Registration Number: NCT06989489
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-05-16
• Study First Posted: 2025-05-25
• Status Verified: 2025-06
• Study Start: 2025-06-16
• Last Update Submitted: 2025-06-17
• Last Update Posted: 2025-06-18
• Primary Completion: 2028-08-30
• Study Completion: 2028-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oral Medication Adherence	Baseline and week 4	Patient's medication adherence of their oral anticancer regiment will be quantified using the PROMIS- medication adherence Likert-type questionnaire, from strongly disagree to strongly agree. Score will change from 1 to 5, with a maximum of 50 and minimum of 10. A higher score reflects better adherence. These answers will help the investigators see if the program was effective in helping the patient's medication adherence.
Acceptability	After 6 months	A study specific survey will be used to measure acceptability. Survey will have Likert-type questions, 1-5 strongly disagree to strongly agree, a higher score reflects better acceptance. Clinicians and administrators will answer the survey to capture their acceptability of the various aspects of the intervention.
Appropriateness	After 6 months	A study specific survey will be used to measure appropriateness. Survey will have Likert-type questions, 1-5 strongly disagree to strongly agree, a higher score reflects better appropriateness. the survey will capture how well the clinicians and administrators graded the various aspects of the intervention.
Everyday use	After 6 months	A study specific survey will be used to measure how applicable for everyday use. Survey will have Likert-type questions, 1-5 strongly disagree to strongly agree, a higher score reflects better everyday use. The survey will capture how easy the intervention is for clinicians and administrators.

Secondary Outcome Measures

Name	Time	Method
Medication knowledge	Baseline and 4 weeks	A study specific survey that includes Likert-types and open-ended questions assessing the participant's knowledge on their medication and treatment will be used. Likert-style questions from strongly disagree to strongly agree with scores ranging from 1 to 5. Higher scores will reflect better knowledge of the participant's medication.
Patient perception	Baseline and 4 weeks	A study specific survey that will include Likert-type questions assessing the participant's perceptions of their cancer care team will be used. Likert-style questions from strongly disagree to strongly agree with scores ranging from 1 to 5. Higher scores will reflect better perceptions of the participants cancer care provider, providers in general, and all people who work in healthcare.
Health literacy	Baseline and 4 weeks	A study specific survey that will include Likert-type questions assessing the participant's health literacy of the instructions of their medication, treatment plan, healthcare professional explanations, and provider education will be used. Likert-style questions will range from not difficult to extremely difficult and scores ranging from 1 to 5. Higher scores will reflect stronger health literacy of the participants.
Self-efficacy	Baseline and 4 weeks	A study specific survey will consist of multiple-choice questions regarding resources participants use to help them take their medications as well as a Likert-style question, from strongly disagree to strongly agree about how and when to call a pharmacist. Likert-style questions will have scores ranging from 1 to 5. Higher scores will reflect better self-efficacy of the participants.
Patient satisfaction	Baseline and 4 weeks	A study specific survey will consist of Likert-style questions, ranging from strongly disagree to strongly agree, regarding the participant's satisfaction of their healthcare team, pharmacy team, care coordination, treatment plan, and education received since starting treatment will be used. Likert-style questions will have scores ranging from 1 to 5. Higher scores will reflect stronger satisfaction of the participants.

Trial Locations

Locations (1)

UNC Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States