- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03924557
Genotype-guided Supportive Care in Symptom Treatment of Cancer Patients
A Randomized Pragmatic Trial of Genotype-guided Supportive Care in Symptom Treatment of Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a single center, pilot randomized pragmatic clinical trial (PCT) of 500 cancer patients who are undergoing chemotherapy for newly diagnosed or recurrent cancers. Patients will be randomized to genotyping intervention vs delayed genotyping intervention supportive care. Supportive care regimens may include therapies for antiemesis (ondansetron), pain management (opiates), GI protection (PPIs), antidepressants (select SSRIs), and antifungal prophylaxis (voriconazole), and warfarin depending on their chemotherapy regimen.
For those randomized to the genotype intervention group, genotype results will be returned in the EHR pre-emptively and supportive care will be prescribed based on genotype results. For those randomized to the delayed genotype intervention group, supportive care will be prescribed based on usual clinical practice. Both groups will be followed for 3 months and undergo assessments with the MDASI questionnaire four times (pre-chemotherapy, and 2 weeks, 4 weeks and 12 weeks post initiation of chemotherapy.
Records for patients receiving outpatient care at the UF Health Cancer Center clinic at the Medical Plaza will be screened based on inclusion / exclusion criteria for participation in this study. Those that meet criteria will be offered participation. Participation is expected to last approximately 12 weeks and the study will be open for 30-36 months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Gainesville, Florida, United States, 32610
- UF Health at the University of Florida
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Gainesville, Florida, United States, 32610
- UF Health Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must have a clinical diagnosis of solid tumor cancer and be seeking treatment and supportive care at the UF Health Cancer Center (Medical Plaza)
- Patients must plan to receive chemotherapy known to be associated with the need for supportive care within 30 days of enrollment
- Life expectancy must be greater than 6 months
- Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Written informed consent obtained from the patient
- The ability for the patient to comply with all the study-related procedures.
Exclusion Criteria:
- Patients unwilling or unable to provide voluntary informed consent
- Patients who are unwilling or unable to comply with protocol requirement and/or follow-up procedures
- Patients planned to undergo cancer therapy other than chemotherapy (i.e., radiation, surgery or hormonal treatment alone)
- Prisoners or patients who are involuntarily incarcerated. Patients who are compulsorily detained for treatment of either a psychiatric or physical illness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Genotyping Intervention Supportive Care
For those randomized to the genotype intervention group, genotype results will be returned in the EHR pre-emptively and supportive care will be prescribed based on genotype results.
|
In this arm, supportive care will be administered based on the results of the genotype test.
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No Intervention: Delayed Genotyping Intervention Supportive Care
For those randomized to the delayed genotype intervention group, supportive care will be prescribed based on usual clinical practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in patient MDASI scoring
Time Frame: At pre-chemotherapy (baseline), 2 weeks, 4 weeks, and 12 weeks post initiation of chemotherapy.
|
The M. D. Anderson Symptom Inventory (MDASI) is a multisymptom patient-reported outcome measure.
Participants are asked to recall symptom interference and severity during the past 24 hours and rate the symptom using a numeric rating scale, 0-10.
For the symptom interference questions, 10 means interfered completely and 0 is did not interfere.
For the symptom severity questions, 10 means as bad as you can imagine and 0 is not present.
The MDASI questionnaire will evaluate symptom distress and core symptoms of patients at four separate time points.
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At pre-chemotherapy (baseline), 2 weeks, 4 weeks, and 12 weeks post initiation of chemotherapy.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in patient medication use
Time Frame: At pre-chemotherapy (baseline), 2 weeks, 4 weeks, and 12 weeks post initiation of chemotherapy.
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Concomitant Medication Review will be collected from patients or from their electronic medical record to evaluate differences in medication use (drug and dose) based on randomized group.
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At pre-chemotherapy (baseline), 2 weeks, 4 weeks, and 12 weeks post initiation of chemotherapy.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rhonda Cooper-DeHoff, Pharm D, MS, University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UF-ETG-002
- OCR20388 (Other Identifier: UF OnCore)
- IRB201901177 (Other Identifier: University of Florida)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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