Pharmacists Coordinated Care Oncology Model (PCOM) for Patients Taking Oral Anti-cancer Medications

NCT ID: NCT04595851

Last Updated: 2022-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-26

Study Completion Date

2022-07-14

Brief Summary

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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 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

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Conditions

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Chronic Myeloid Leukemia Chronic Lymphocytic Leukemia Multiple Chronic Conditions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Pharmacist Coordinated care Oncology Model (PCOM)

The Pharmacist Coordinated care Oncology Model includes patient self-reported symptoms and medication adherence, comprehensive medication review(s) and intentional communication between oncology and primary care pharmacists.

Group Type OTHER

Patient Reported Outcome Measure (PROM)

Intervention Type OTHER

Participants will complete a PROM (Michigan Oncology Quality Consortium, Patient Assessment Tool for Oral Chemotherapy) for their oral anticancer agent (OAA) at two timepoints over 2 months, to assess patient symptoms and adherence to OAA.

Comprehensive Medication Review (CMR)

Intervention Type OTHER

Following the first PROM, participants will be contacted by the primary care pharmacist for a Comprehensive Medication Review (CMR) for their chronic medications. If warranted, a follow-up CMR will take place after the second PROM.

Communications between oncology and primary care pharmacists

Intervention Type OTHER

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

Interventions

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Patient Reported Outcome Measure (PROM)

Participants will complete a PROM (Michigan Oncology Quality Consortium, Patient Assessment Tool for Oral Chemotherapy) for their oral anticancer agent (OAA) at two timepoints over 2 months, to assess patient symptoms and adherence to OAA.

Intervention Type OTHER

Comprehensive Medication Review (CMR)

Following the first PROM, participants will be contacted by the primary care pharmacist for a Comprehensive Medication Review (CMR) for their chronic medications. If warranted, a follow-up CMR will take place after the second PROM.

Intervention Type OTHER

Communications between oncology and primary care pharmacists

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Has primary care physician
* Diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), chronic myeloid leukemia (CML), or multiple myeloma (MM)
* Initiating an OAA, either for the first time or a change from previous OAA
* Diagnosis of at least 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 speak English
* Concurrent diagnosis of type 1 diabetes
* Concurrent diagnosis of human immunodeficiency virus
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Farris, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan College of Pharmacy

Locations

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University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00178781

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2020.053

Identifier Type: -

Identifier Source: org_study_id

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