Oral Chemotherapy Adherence Program for Cancer

Overseen By Bethel Belayneh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Must be taking: Oral anticancer agents

Disqualifiers: Non-continuous therapy, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

160 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Benyam Muluneh, PharmD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults with solid tumors or blood cancers who have been on oral anticancer medications for at least six months. It's being conducted in various clinics, including academic, urban, and rural settings.

Inclusion Criteria

I have been diagnosed with cancer.

I have been on a single oral cancer drug for at least 6 months.

I am 21 years old or older.

Exclusion Criteria

Patients enrolled on hospice

I am on a treatment plan that is not continuous.

I am receiving care focused on comfort for end-of-life.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-implementation

Participants complete a survey and provide medication information prior to program enrollment

6 months

Post-implementation

Participants enrolled in the adherence program receive individualized counseling and are monitored for medication adherence

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Multilevel Adherence Intervention

Trial Overview The study tests a new program designed to help patients stick to their oral chemotherapy treatment plans. Participants are divided into two groups: one before the program starts and one after it's been running for six months, each surveyed about medication adherence.

Participant Groups

Group I: Intervention participants Experimental Treatment 1 Intervention

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.

Group II: Standard of Care patients Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+