Implementation of an Oral Chemotherapy Adherence Intervention
Design and Implementation of a Social Cognitive Theory-based Medication Adherence Intervention
2 other identifiers
interventional
160
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2025
CompletedFirst Posted
Study publicly available on registry
May 25, 2025
CompletedStudy Start
First participant enrolled
May 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2028
July 8, 2025
June 1, 2025
3.3 years
January 17, 2025
July 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Oral Medication Adherence
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.
Baseline and week 4
Acceptability
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.
After 6 months
Appropriateness
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.
After 6 months
Everyday use
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.
After 6 months
Secondary Outcomes (5)
Medication knowledge
Baseline and 4 weeks
Patient perception
Baseline and 4 weeks
Health literacy
Baseline and 4 weeks
Self-efficacy
Baseline and 4 weeks
Patient satisfaction
Baseline and 4 weeks
Study Arms (2)
Standard of Care patients
NO INTERVENTIONClinical 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.
Intervention participants
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients on time-limited or intermittent therapy (non-continuous)
- Patients on comfort (end-of-life) care
- Patients enrolled on hospice
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UNC Chapel Hill
Chapel Hill, North Carolina, 27516, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benyam Muluneh, PharmD
UNC Lineberger Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will not be aware that they are receiving a different follow up pattern from other patients.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2025
First Posted
May 25, 2025
Study Start
May 28, 2025
Primary Completion (Estimated)
August 30, 2028
Study Completion (Estimated)
August 30, 2028
Last Updated
July 8, 2025
Record last verified: 2025-06