Implementation of an Oral Chemotherapy Adherence Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multilevel Adherence Intervention.
- Who it may be relevant to
- Registry conditions: Solid Tumor, Hematologic Malignancy. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Design and Implementation of a Social Cognitive Theory-based Medication Adherence Intervention
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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 measures
- 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]
Secondary outcome measures (5)
- Medication knowledge [Time frame: Baseline and 4 weeks]
- Patient perception [Time frame: Baseline and 4 weeks]
- Health literacy [Time frame: Baseline and 4 weeks]
- Self-efficacy [Time frame: Baseline and 4 weeks]
- Patient satisfaction [Time frame: Baseline and 4 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- UNC Chapel Hill — Chapel Hill
Identifiers
NCT: NCT06989489 · LCCC2125-AIM3 · K08CA279500