Chronic Myeloid LeukemiaNCT04663100
Oral Adherence in Hematological Oncology Agents and Impact on Comorbid Therapy Adherence
A study testing Patient-reported outcome measure, Comprehensive Medication Review and Pharmacist communication in people with Chronic Myeloid Leukemia and Chronic Lymphocytic Leukemia, run by University of Tennessee at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia, Multiple Myeloma
- What is being tested?
- Patient-reported outcome measure, Comprehensive Medication Review and Pharmacist communication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cannot communicate in English
- Concurrent diagnosis of type 1 diabetes or human immunodeficiency virus
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Katie Gatwood, PharmD, 615-936-0200, katie.s.gatwood@vumc.org
About this study
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
- Being tested
- Patient-reported outcome measure, Comprehensive Medication Review, Pharmacist communication
- Keywords
- adherence, leukemia, anticancer agents, chronic disease management, pharmacy practice, hematological malignancy
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Lymphocytic, Chronic, B-Cell, Multiple Myeloma, Multiple Chronic Conditions, Leukemia, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-reported outcome measureOther
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 ReviewOther
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 communicationOther
Throughout the study, the oncology and community pharmacists will communicate about medications through the electronic medical record.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patient-reported outcome measure; Other: Comprehensive Medication Review; Other: Pharmacist communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 6 months pre- and post-initiation of the oral anticancer agent
Secondary outcomes (5)
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.
Measured: Approximately 42 days after oral anticancer agent initiation
Comprehensive Medication Review (CMR) completion
Proportion of enrolled subjects completing the initial and follow-up CMRs with the community pharmacist
Measured: Approximately 50 days after oral anticancer agent initiation
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.
Measured: Approximately 44 days after oral anticancer agent initiation
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.
Measured: Approximately 43 days after oral anticancer agent initiation
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.
Measured: Approximately 44 days after oral anticancer agent initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start8 Feb 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center, AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663100
- Sponsor's protocol ID
- 20-0839
- Status last verified
- Nov 2023
- First submitted
- 3 Dec 2020
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Adherence in Hematological Oncology Agents and Impact on Comorbid Therapy Adherence
- ClinicalTrials.gov ID
- NCT04663100
- Acronym / sponsor ID
- 20-0839
- Conditions
- Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia, Multiple Myeloma, Multiple Chronic Conditions
- Keywords
- adherence, leukemia, anticancer agents, chronic disease management, pharmacy practice, hematological malignancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center, AstraZeneca
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacist Coordinated care Oncology Model | Experimental | Other: Patient-reported outcome measure, Other: Comprehensive Medication Review, Other: Pharmacist communicationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Cannot communicate in English
- Concurrent diagnosis of type 1 diabetes or human immunodeficiency virus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-reported outcome measureParticipants 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. | Other | Pharmacist Coordinated care Oncology Model |
| Comprehensive Medication ReviewFollowing 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. | Other | Pharmacist Coordinated care Oncology Model |
| Pharmacist communicationThroughout the study, the oncology and community pharmacists will communicate about medications through the electronic medical record. | Other | Pharmacist Coordinated care Oncology Model |
Primary outcome
Oral anticancer agent adherence by proportion of days covered (PDC)
Time frame: Up to 6 months post-initiation
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
Time frame: 6 months pre- and post-initiation of the oral anticancer agent
PDCs for medications for select chronic diseases will be calculated for the 6 months before and after oral anticancer agent initiation
5 secondary outcomes
Patient-reported outcome measure completion
Time frame: Approximately 42 days after oral anticancer agent initiation
Comprehensive Medication Review (CMR) completion
Time frame: Approximately 50 days after oral anticancer agent initiation
Oncology pharmacist review of patient-reported outcome measure
Time frame: Approximately 44 days after oral anticancer agent initiation
Percent of Comprehensive Medication Reviews (CMRs) where note was routed to oncology pharmacist
Time frame: Approximately 43 days after oral anticancer agent initiation
Proportion of Comprehensive Medication Reviews (CMRs) reviewed by the oncology pharmacist
Time frame: Approximately 44 days after oral anticancer agent initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-reported outcome measure, Comprehensive Medication Review and Pharmacist communication in people with Chronic Myeloid Leukemia and Chronic Lymphocytic Leukemia, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin Gatwood, PhD (6155323403, jgatwood@uthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral anticancer agent adherence by proportion of days covered (PDC) (time frame: Up to 6 months post-initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.