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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04663100
• Other study ID #: 20-0839
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: University of Tennessee
• Contact: Justin Gatwood, PhD
• Phone: 6155323403
• Email: jgatwood[@]uthsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Lymphocytic Leukemia
• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Multiple Chronic Conditions
• Multiple Myeloma

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
University of Tennessee	AstraZeneca, Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral anticancer agent adherence by proportion of days covered (PDC)	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.	Up to 6 months post-initiation
Primary	Chronic disease medication adherence	PDCs for medications for select chronic diseases will be calculated for the 6 months before and after oral anticancer agent initiation	6 months pre- and post-initiation of the oral anticancer agent
Secondary	Patient-reported outcome measure completion	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.	Approximately 42 days after oral anticancer agent initiation
Secondary	Comprehensive Medication Review (CMR) completion	Proportion of enrolled subjects completing the initial and follow-up CMRs with the community pharmacist	Approximately 50 days after oral anticancer agent initiation
Secondary	Oncology pharmacist review of patient-reported outcome measure	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.	Approximately 44 days after oral anticancer agent initiation
Secondary	Percent of Comprehensive Medication Reviews (CMRs) where note was routed to oncology pharmacist	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.	Approximately 43 days after oral anticancer agent initiation
Secondary	Proportion of Comprehensive Medication Reviews (CMRs) reviewed by the oncology pharmacist	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.	Approximately 44 days after oral anticancer agent initiation