Oral Adherence in Hematological Oncology Agents and Impact on Comorbid Therapy Adherence
NCT ID: NCT04663100
Last Updated: 2023-12-04
Study Results
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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RECRUITING
NA
30 participants
INTERVENTIONAL
2021-02-08
2023-12-31
Brief Summary
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This is a pilot study in which the investigators will examine the association between outcome measures, but the study design and sample size are insufficient to quantify the impact of OAA initiation or OAA adherence on adherence to chronic medications. This pilot study and data analyses are being done in preparation for a larger, controlled study.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Pharmacist Coordinated care Oncology Model
The Pharmacist Coordinated care Oncology Model includes patient self-reported symptoms and medication adherence, comprehensive medication review(s) and intentional communication between oncology and community pharmacists.
Patient-reported outcome measure
Participants will complete a patient-reported outcome measure for their oral anticancer agent at two timepoints over 2 months, to assess patient symptoms and adherence to their oral anticancer agent.
Comprehensive Medication Review
Following the first patient-reported outcome measure, participants will be contacted by the community pharmacist for a Comprehensive Medication Review (CMR) for their chronic medications. A follow-up CMR will take place after the second patient-reported outcome measure.
Pharmacist communication
Throughout the study, the oncology and community pharmacists will communicate about medications through the electronic medical record.
Interventions
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Patient-reported outcome measure
Participants will complete a patient-reported outcome measure for their oral anticancer agent at two timepoints over 2 months, to assess patient symptoms and adherence to their oral anticancer agent.
Comprehensive Medication Review
Following the first patient-reported outcome measure, participants will be contacted by the community pharmacist for a Comprehensive Medication Review (CMR) for their chronic medications. A follow-up CMR will take place after the second patient-reported outcome measure.
Pharmacist communication
Throughout the study, the oncology and community pharmacists will communicate about medications through the electronic medical record.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), chronic myeloid leukemia (CML), or multiple myeloma (MM)
* Initiating an oral anticancer agent, either for the first time or a change from previous oral agent
* Diagnosis of 2 chronic conditions, including at least one of the following: diabetes, hypertension, hyperlipidemia, congestive heart failure, depression/anxiety, gastroesophageal reflux disease, and/or chronic obstructive pulmonary disease
* Patients taking at least two chronic medications, including at least one medication for one of the conditions listed above.
* Willing and able to sign informed consent.
Exclusion Criteria
* Concurrent diagnosis of type 1 diabetes or human immunodeficiency virus
18 Years
ALL
No
Sponsors
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University of Tennessee
OTHER
Vanderbilt University Medical Center
OTHER
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Katie Gatwood, PharmD
Role: primary
Other Identifiers
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20-0839
Identifier Type: -
Identifier Source: org_study_id