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Clinical Trials/NCT04663100
NCT04663100
Recruiting
Not Applicable

Oral Adherence in Hematological Oncology Agents and Impact on Comorbid Therapy Adherence

University of Tennessee1 site in 1 country30 target enrollmentFebruary 8, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Myeloid Leukemia
Sponsor
University of Tennessee
Enrollment
30
Locations
1
Primary Endpoint
Oral anticancer agent adherence by proportion of days covered (PDC)
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The objective of this study is to improve medication, symptom, and disease management of patients with hematological malignancies and multiple chronic conditions (2 or more conditions in addition to cancer) through care coordination between pharmacists working in oncology practices and those working in primary care or community practices (Pharmacists Coordinated care Oncology Model [PCOM]).

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.

Registry
clinicaltrials.gov
Start Date
February 8, 2021
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Receiving cancer care at Vanderbilt University Medical Center
  • 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

  • Cannot communicate in English
  • Concurrent diagnosis of type 1 diabetes or human immunodeficiency virus

Outcomes

Primary Outcomes

Oral anticancer agent adherence by proportion of days covered (PDC)

Time Frame: Up to 6 months post-initiation

PDC is a common medication adherence metric, and assesses the ratio of number of days the patient is supplied with oral anticancer agent, from the time of initiation until 6 months later, to the total number of days during that period. Data from the electronic medical record for dose changes will be aligned with the refill data to calculate a dose-adjusted PDC.

Chronic disease medication adherence

Time Frame: 6 months pre- and post-initiation of the oral anticancer agent

PDCs for medications for select chronic diseases will be calculated for the 6 months before and after oral anticancer agent initiation

Secondary Outcomes

  • Oncology pharmacist review of patient-reported outcome measure(Approximately 44 days after oral anticancer agent initiation)
  • Percent of Comprehensive Medication Reviews (CMRs) where note was routed to oncology pharmacist(Approximately 43 days after oral anticancer agent initiation)
  • Patient-reported outcome measure completion(Approximately 42 days after oral anticancer agent initiation)
  • Comprehensive Medication Review (CMR) completion(Approximately 50 days after oral anticancer agent initiation)
  • Proportion of Comprehensive Medication Reviews (CMRs) reviewed by the oncology pharmacist(Approximately 44 days after oral anticancer agent initiation)

Study Sites (1)

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