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

November 30, 2023 updated by: University of Tennessee

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other: 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.
Other: Pharmacist communication
Throughout the study, the oncology and community pharmacists will communicate about medications through the electronic medical record.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 6 months post-initiation
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
6 months pre- and post-initiation of the oral anticancer agent

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported outcome measure completion
Time Frame: 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.
Approximately 42 days after oral anticancer agent initiation
Comprehensive Medication Review (CMR) completion
Time Frame: Approximately 50 days after oral anticancer agent initiation
Proportion of enrolled subjects completing the initial and follow-up CMRs with the community pharmacist
Approximately 50 days after oral anticancer agent initiation
Oncology pharmacist review of patient-reported outcome measure
Time Frame: 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.
Approximately 44 days after oral anticancer agent initiation
Percent of Comprehensive Medication Reviews (CMRs) where note was routed to oncology pharmacist
Time Frame: 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.
Approximately 43 days after oral anticancer agent initiation
Proportion of Comprehensive Medication Reviews (CMRs) reviewed by the oncology pharmacist
Time Frame: 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.
Approximately 44 days after oral anticancer agent initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Collaborators

AstraZeneca
Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2021

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

December 3, 2020

First Submitted That Met QC Criteria

December 3, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-0839

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on Patient-reported outcome measure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe