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

NCT04663100 | Unknown

• 1 other identifier: 20-0839
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myeloid Leukemia; Chronic Lymphocytic Leukemia; Multiple Myeloma; Multiple Chronic Conditions

Keywords

adherence; leukemia; anticancer agents; chronic disease management; pharmacy practice; hematological malignancy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• 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

• 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

• Proportion of Comprehensive Medication Reviews (CMRs) reviewed by the oncology pharmacist

  Approximately 44 days after oral anticancer agent initiation

Study Arms (1)

Pharmacist Coordinated care Oncology Model

EXPERIMENTAL

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; Other: Comprehensive Medication Review; Other: Pharmacist communication

Interventions

Patient-reported outcome measure OTHER

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.

Pharmacist Coordinated care Oncology Model

Comprehensive Medication Review OTHER

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 Coordinated care Oncology Model

Pharmacist communication OTHER

Throughout the study, the oncology and community pharmacists will communicate about medications through the electronic medical record.

Pharmacist Coordinated care Oncology Model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Tennessee: lead
• Vanderbilt University Medical Center: collaborator
• AstraZeneca: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Lymphocytic, Chronic, B-Cell; Multiple Myeloma; Multiple Chronic Conditions; Leukemia; Hematologic Neoplasms

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Central Study Contacts

Justin Gatwood, PhD

CONTACT

6155323403; jgatwood@uthsc.edu

Katie Gatwood, PharmD

CONTACT

6153433836; katie.s.gatwood@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 10, 2020
• Study Start: February 8, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)