Recruiting

Observational Study

Sponsor:

University of Tennessee

Code:

NCT04663100

Conditions

Chronic Myeloid Leukemia

Chronic Lymphocytic Leukemia

Multiple Myeloma

Multiple Chronic Conditions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patient-reported outcome measure

Comprehensive Medication Review

Pharmacist communication

Study Details

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

Study ID

NCT04663100

Start date

Feb 8, 2021

Status verified date

Nov, 2023

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Oral anticancer agent adherence by proportion of days covered (PDC) [ Time Frame: Up to 6 months post-initiation ]
  • Chronic disease medication adherence [ Time Frame: 6 months pre- and post-initiation of the oral anticancer agent ]

Central Contacts and Locations

Central contacts

Justin Gatwood, PhD

6155323403jgatwood@uthsc.edu

Katie Gatwood, PharmD

6153433836katie.s.gatwood@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Katie Gatwood, PharmD

615-936-0200katie.s.gatwood@vumc.org

More Information

Sponsor

University of Tennessee

Last update posted

Dec 4, 2023

Last verified

Nov, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Tennessee on 2023-12-04.