Chronic Myeloid LeukemiaNCT04595851
Pharmacists Coordinated Care Oncology Model (PCOM) for Patients Taking Oral Anti-cancer Medications
A study testing Patient Reported Outcome Measure (PROM), Comprehensive Medication Review (CMR) and Communications between oncology and primary care pharmacists in people with Chronic Myeloid Leukemia and Chronic Lymphocytic Leukemia, run by University of Michigan Rogel Cancer Center 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… 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 Chronic Conditions
- What is being tested?
- Patient Reported Outcome Measure (PROM), Comprehensive Medication Review (CMR) and Communications between oncology and primary care pharmacists
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2021to 14 Jul 2022
- 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
- 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.
Who cannot join
- Cannot speak English
- Concurrent diagnosis of type 1 diabetes
- Concurrent diagnosis of human immunodeficiency virus
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: Implementation of a Model Integrating Primary and Oncology Care for Patients Taking Oral Anticancer Agents (OAA)
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.
- Being tested
- Patient Reported Outcome Measure (PROM), Comprehensive Medication Review (CMR), Communications between oncology and primary care pharmacists
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Lymphocytic, Chronic, B-Cell, Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Reported Outcome Measure (PROM)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)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 pharmacistsOther
Throughout the study, the oncology and primary care pharmacists will communicate about medications through the electronic medical record.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist Coordinated care Oncology Model (PCOM) | Other | 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. Receives: Other: Patient Reported Outcome Measure (PROM); Other: Comprehensive Medication Review (CMR); Other: Communications between oncology and primary care pharmacists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-adjusted proportion of days covered (PDC) for oral anti-cancer agent (OAA)
PDC is a common way to assess a patient's adherence to a medication regimen. PDC is the ratio of number of days the patient is supplied with OAA medication, from the time of OAA initiation until 6 months later, to the total number of days during that period. For OAAs, data from the electronic medical record (EMR) for dose changes will be aligned with the refill data to calculate a dose-adjusted PDC.
Measured: Up to 6 months following OAA initiation
PDC for chronic condition medications
PDC is the ratio of the number of days the patient is supplied with chronic condition medications, from the time of OAA initiation until 6 months later, to the total number of days during that period.
Measured: Up to 6 months following OAA initiation
Secondary outcomes (6)
Percent of patients with two completed Patient Reported Outcome Measures (PROMs)
The Michigan Oncology Quality Consortium (MOQC) OAA PROM, Patient Assessment Tool for Oral Chemotherapy is to be completed at 2 and 6 weeks after OAA initiation. This measure assesses the percent of patients who complete this PROM at both time points.
Measured: Up to day 42 (+/-3) after OAA initiation
Percent of patients with completed Comprehensive Medication Reviews (CMRs)
Completed CMR includes initial and follow-up CMR with primary care pharmacist.
Measured: Day 50 (+/-3) after OAA initiation
Percent of patients with scheduled Comprehensive Medication Review (CMR) within one week of first PROM result
The PROM is scored within one day after it is completed by the patient. The primary care pharmacist sets a date and time for the initial CMR after receiving the first scored PROM.
Measured: Day 22 (+/-3) after OAA initiation
Percent of patients where oncology pharmacist reviewed PROM within 1 day of receiving scored PROM
The PROM is scored within one day after it is completed by the patient and is routed to the oncology pharmacist to review the results. The number of PROMs that are reviewed within 1 day of receipt will be assessed at 2 weeks and at 6 weeks.
Measured: Up to day 44 (+/-3) after OAA initiation
Percent of CMRs where note was routed to oncology pharmacist
The number of CMR where note was routed to oncology pharmacist out of total number of completed CMRs, assessed at 2 weeks and at 6 weeks.
Measured: Up to day 43 (+/-3) after OAA initiation
Percent of CMR notes that oncology pharmacist reviewed
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: Up to day 44 (+/-3) after OAA initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start26 Mar 2021
- Primary completion14 Jul 2022
- Study completion14 Jul 2022
Why it stopped: accrual difficulties
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.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Karen Farris, PhD, Principal investigator, University of Michigan College of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595851
- Sponsor's protocol ID
- UMCC 2020.053
- Other IDs
- HUM00178781
- Status last verified
- Nov 2022
- First submitted
- 13 Oct 2020
- Last updated
- 22 Nov 2022
- Results posted
- 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 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Model Integrating Primary and Oncology Care for Patients Taking Oral Anticancer Agents (OAA)
- ClinicalTrials.gov ID
- NCT04595851
- Acronym / sponsor ID
- UMCC 2020.053
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: accrual difficulties
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 14 Jul 2022 (actual)
- Study completion
- 14 Jul 2022 (actual)
- First posted
- 22 Oct 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 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 (PCOM) | Other | Other: Patient Reported Outcome Measure (PROM), Other: Comprehensive Medication Review (CMR), Other: Communications between oncology and primary care pharmacistsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Cannot speak English
- Concurrent diagnosis of type 1 diabetes
- Concurrent diagnosis of 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 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. | Other | Pharmacist Coordinated care Oncology Model (PCOM) |
| 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. | Other | Pharmacist Coordinated care Oncology Model (PCOM) |
| Communications between oncology and primary care pharmacistsThroughout the study, the oncology and primary care pharmacists will communicate about medications through the electronic medical record. | Other | Pharmacist Coordinated care Oncology Model (PCOM) |
Primary outcome
Dose-adjusted proportion of days covered (PDC) for oral anti-cancer agent (OAA)
Time frame: Up to 6 months following OAA initiation
PDC is a common way to assess a patient's adherence to a medication regimen. PDC is the ratio of number of days the patient is supplied with OAA medication, from the time of OAA initiation until 6 months later, to the total number of days during that period. For OAAs, data from the electronic medical record (EMR) for dose changes will be aligned with the refill data to calculate a dose-adjusted PDC.
PDC for chronic condition medications
Time frame: Up to 6 months following OAA initiation
PDC is the ratio of the number of days the patient is supplied with chronic condition medications, from the time of OAA initiation until 6 months later, to the total number of days during that period.
6 secondary outcomes
Percent of patients with two completed Patient Reported Outcome Measures (PROMs)
Time frame: Up to day 42 (+/-3) after OAA initiation
Percent of patients with completed Comprehensive Medication Reviews (CMRs)
Time frame: Day 50 (+/-3) after OAA initiation
Percent of patients with scheduled Comprehensive Medication Review (CMR) within one week of first PROM result
Time frame: Day 22 (+/-3) after OAA initiation
Percent of patients where oncology pharmacist reviewed PROM within 1 day of receiving scored PROM
Time frame: Up to day 44 (+/-3) after OAA initiation
Percent of CMRs where note was routed to oncology pharmacist
Time frame: Up to day 43 (+/-3) after OAA initiation
Percent of CMR notes that oncology pharmacist reviewed
Time frame: Up to day 44 (+/-3) after OAA initiation
Results and safety
The study was stopped early (reason given: accrual difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- 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.
Karen Farris, PhD principal investigator
University of Michigan College of Pharmacy
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 (PROM), Comprehensive Medication Review (CMR) and Communications between oncology and primary care pharmacists in people with Chronic Myeloid Leukemia and Chronic Lymphocytic Leukemia, run by University of Michigan Rogel Cancer Center 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 3 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: stopped early, as of the sponsor's last update on 22 Nov 2022. 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?
The study was stopped early (reason given: accrual difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-adjusted proportion of days covered (PDC) for oral anti-cancer agent (OAA) (time frame: Up to 6 months following OAA 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 22 Nov 2022.