Clinical trial NCT04663100: 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
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Myeloid Leukemia
Chronic Lymphocytic Leukemia
Multiple Myeloma
Multiple Chronic Conditions
Keywords: adherence
leukemia
anticancer agents
chronic disease management
pharmacy practice
hematological malignancy
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
name: AstraZeneca
First posted: 2020-12-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Oral anticancer agent adherence by proportion of days covered (PDC)
timeFrame: Up to 6 months post-initiation
measure: Chronic disease medication adherence
timeFrame: 6 months pre- and post-initiation of the oral anticancer agent
Secondary outcomes:
measure: Patient-reported outcome measure completion
timeFrame: Approximately 42 days after oral anticancer agent initiation
measure: Comprehensive Medication Review (CMR) completion
timeFrame: Approximately 50 days after oral anticancer agent initiation
measure: Oncology pharmacist review of patient-reported outcome measure
timeFrame: Approximately 44 days after oral anticancer agent initiation
measure: Percent of Comprehensive Medication Reviews (CMRs) where note was routed to oncology pharmacist
timeFrame: Approximately 43 days after oral anticancer agent initiation
measure: Proportion of Comprehensive Medication Reviews (CMRs) reviewed by the oncology pharmacist
timeFrame: Approximately 44 days after oral anticancer agent initiation
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: