Implementation of an Oral Chemotherapy Adherence Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorUNC Lineberger Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients on time-limited or intermittent therapy (non-continuous)
Patients on comfort (end-of-life) care
Patients enrolled on hospice
Trial design
Design model
Parallel
Treatments tested in this trial
Multilevel Adherence Intervention
BehavioralParticipants 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Standard of Care patientsNo intervention 0 interventions
Group B: Intervention participantsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and week 42
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.
Time frame
After 6 months3
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.
Time frame
After 6 months4
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.
Time frame
After 6 monthsSecondary outcomes
1
Medication knowledge
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.
Time frame
Baseline and 4 weeks2
Patient perception
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.
Time frame
Baseline and 4 weeks3
Health literacy
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.
Time frame
Baseline and 4 weeks4
Self-efficacy
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.
Time frame
Baseline and 4 weeksSponsors and contacts
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UNC Lineberger Comprehensive Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov