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NCT Number: NCT06989489

Implementation of an Oral Chemotherapy Adherence Intervention

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.

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Key information

Conditions

Solid Tumor Hematologic Diseases Hematologic Malignancy Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location status: Recruiting

Location contact

Benyam Muluneh

CONTACT

[email protected]

919-962-0070

Benyam Muluneh, Pharm.D.

PRINCIPAL_INVESTIGATOR

Bethel Belayneh

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Multicomponent Adherence Intervention

Primary outcomes

  1. Oral Medication Adherence

    Time frame: 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.

  2. Acceptability

    Time frame: 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.

  3. Appropriateness

    Time frame: 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.

  4. Everyday use

    Time frame: 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 outcomes

  1. Medication knowledge

    Time frame: 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.

  2. Patient perception

    Time frame: 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.

  3. Health literacy

    Time frame: 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.

  4. Self-efficacy

    Time frame: 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.

  5. Patient satisfaction

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bethel Belayneh

CONTACT

[email protected]

7039154836

Solomon Ayehu, MD

CONTACT

[email protected]

9196722032

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Design and Implementation of a Social Cognitive Theory-based Medication Adherence Intervention

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 25, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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