Recruiting

Anticancer Agent

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06989489

Conditions

Solid Tumor

Hematologic Malignancy

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Multilevel Adherence Intervention

Study Details

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.

Conditions

Solid Tumor

Hematologic Malignancy

Study ID

NCT06989489

Start date

May 28, 2025

Status verified date

Jul, 2026

Completion date

Aug 30, 2028

Anticipated

Primary completion date

Aug 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Standard of Care patients

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.

experimental: Intervention participants

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.

Interventions

Multilevel Adherence Intervention

Participants enrolled in this adherence program will have individualized counseling sessions with their clinical pharmacists regarding their oral anticancer agent based on their risk-stratified monitoring category. Participants will be followed longitudinally and will receive tailored support.

Primary outcome measure

  • Oral Medication Adherence [ Time Frame: Baseline and week 4 ]
  • Acceptability [ Time Frame: After 6 months ]
  • Appropriateness [ Time Frame: After 6 months ]
  • Everyday use [ Time Frame: After 6 months ]

Central Contacts and Locations

Central contacts

Locations

UNC Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27516

Contacts

Principal Investigator:

Benyam Muluneh, Pharm.D.

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • oral anticancer agent
  • oral chemotherapy
  • adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-07-08.