Implementation of an Oral Chemotherapy Adherence Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-28

Study Completion Date

2028-08-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Solid Tumor Hematologic Malignancy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Surveys will be administered to two different groups, before implementation and after implementation of intervention.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Participants will not be aware that they are receiving a different follow up pattern from other patients.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Multilevel Adherence Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Multicomponent Adherence Intervention

Eligibility Criteria

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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