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

Not Applicable

Recruiting

• Conditions: Chronic Lymphocytic Leukemia; Multiple Myeloma; Chronic Myeloid Leukemia; Multiple Chronic Conditions
• Interventions: Other: Patient-reported outcome measure; Other: Comprehensive Medication Review; Other: Pharmacist communication

• Registration Number: NCT04663100
• Lead Sponsor: University of Tennessee

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-10
• Study Start: 2021-02-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-04
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pharmacist Coordinated care Oncology Model	Pharmacist communication	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.
Pharmacist Coordinated care Oncology Model	Patient-reported outcome measure	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.
Pharmacist Coordinated care Oncology Model	Comprehensive Medication Review	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.

Primary Outcome Measures

Name	Time	Method
Oral anticancer agent adherence by proportion of days covered (PDC)	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	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 Outcome Measures

Name	Time	Method
Oncology pharmacist review of patient-reported outcome measure	Approximately 44 days after oral anticancer agent initiation	The patient-reported outcome measure is scored within one day after it is completed by the subject and is routed to the oncology pharmacist to review the results. The number of measures that are reviewed within 1 day of receipt will be assessed at 2 weeks and at 6 weeks.
Percent of Comprehensive Medication Reviews (CMRs) where note was routed to oncology pharmacist	Approximately 43 days after oral anticancer agent initiation	The number of CMRs where note was routed to oncology pharmacist out of total number of completed CMRs, assessed at 2 weeks and at 6 weeks.
Patient-reported outcome measure completion	Approximately 42 days after oral anticancer agent initiation	The oncology-specific patient-reported outcome measure is to be completed at 2 and 6 weeks after oral anticancer agent initiation. This measure assesses the percent of patients who complete this tool at both time points.
Comprehensive Medication Review (CMR) completion	Approximately 50 days after oral anticancer agent initiation	Proportion of enrolled subjects completing the initial and follow-up CMRs with the community pharmacist
Proportion of Comprehensive Medication Reviews (CMRs) reviewed by the oncology pharmacist	Approximately 44 days after oral anticancer agent initiation	The number of CMR notes reviewed by the oncology pharmacist out of the total number of completed CMRs, assessed at 2 weeks and at 6 weeks.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States