Implementation of an Oral Chemotherapy Adherence Intervention

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT06989489
Status
Recruiting
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Conditions

  • Hematologic Malignancy
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Multilevel Adherence Intervention — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 28, 2025
Status verified
Jun 2025
Primary completion
Aug 30, 2028
Completion
Aug 30, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Oral Medication Adherence [ Time Frame: Baseline and week 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UNC Chapel HillChapel HillNorth Carolina27516
Benyam Muluneh
[email protected]
919-962-0070
Bethel Belayneh
[email protected]
Benyam Muluneh, Pharm.D. (PRINCIPAL_INVESTIGATOR)

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