Back to resultsOral Adherence in Hematological Oncology Agents and Impact on Comorbid Therapy Adherence
Primary Purpose
Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia, Multiple Myeloma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient-reported outcome measure
Comprehensive Medication Review
Pharmacist communication
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Myeloid Leukemia focused on measuring adherence, leukemia, anticancer agents, chronic disease management, pharmacy practice, hematological malignancy
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
Sites / Locations
- Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pharmacist Coordinated care Oncology Model
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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.
Comprehensive Medication Review (CMR) completion
Proportion of enrolled subjects completing the initial and follow-up CMRs with the community pharmacist
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.
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.
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.
Full Information
NCT ID
NCT04663100
First Posted
December 3, 2020
Last Updated
June 1, 2022
Sponsor
University of Tennessee
Collaborators
Vanderbilt University Medical Center, AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT04663100
Brief Title
Oral Adherence in Hematological Oncology Agents and Impact on Comorbid Therapy Adherence
Official Title
Oral Adherence in Hematological Oncology Agents and Impact on Comorbid Therapy Adherence
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee
Collaborators
Vanderbilt University Medical Center, AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia, Multiple Myeloma, Multiple Chronic Conditions
Keywords
adherence, leukemia, anticancer agents, chronic disease management, pharmacy practice, hematological malignancy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pharmacist Coordinated care Oncology Model
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Patient-reported outcome measure
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Comprehensive Medication Review
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pharmacist communication
Intervention Description
Throughout the study, the oncology and community pharmacists will communicate about medications through the electronic medical record.
Primary Outcome Measure Information:
Title
Oral anticancer agent adherence by proportion of days covered (PDC)
Description
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.
Time Frame
Up to 6 months post-initiation
Title
Chronic disease medication adherence
Description
PDCs for medications for select chronic diseases will be calculated for the 6 months before and after oral anticancer agent initiation
Time Frame
6 months pre- and post-initiation of the oral anticancer agent
Secondary Outcome Measure Information:
Title
Patient-reported outcome measure completion
Description
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.
Time Frame
Approximately 42 days after oral anticancer agent initiation
Title
Comprehensive Medication Review (CMR) completion
Description
Proportion of enrolled subjects completing the initial and follow-up CMRs with the community pharmacist
Time Frame
Approximately 50 days after oral anticancer agent initiation
Title
Oncology pharmacist review of patient-reported outcome measure
Description
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.
Time Frame
Approximately 44 days after oral anticancer agent initiation
Title
Percent of Comprehensive Medication Reviews (CMRs) where note was routed to oncology pharmacist
Description
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.
Time Frame
Approximately 43 days after oral anticancer agent initiation
Title
Proportion of Comprehensive Medication Reviews (CMRs) reviewed by the oncology pharmacist
Description
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.
Time Frame
Approximately 44 days after oral anticancer agent initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justin Gatwood, PhD
Phone
6155323403
Email
jgatwood@uthsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Katie Gatwood, PharmD
Phone
6153433836
Email
katie.s.gatwood@vumc.org
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Gatwood, PharmD
Phone
615-936-0200
Email
katie.s.gatwood@vumc.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oral Adherence in Hematological Oncology Agents and Impact on Comorbid Therapy Adherence
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