Advanced Cancer, Advanced Solid Tumor, Behavior Disorders, Cancer, Mental Health Issue
Conditions
Keywords
tumor, advanced cancer, advanced solid tumor, cancer medication, prescriptions, inhibitor drug, inducer drug
Brief summary
The purpose of this study is to determine whether a consultation with a Personalized Therapeutics Clinic, or PTC, will help participants lower the risk for side effects (drug-drug interactions and drug-gene interactions) when taking many medications and help providers improve prescribing decisions for participants. A PTC is a clinical that will test your genes to gather information about your health that may help guide prescribing advice and offer you new information about your prescriptions. Doctors leading this study will look for variations (differences) in your genes that may suggest that you are at greater risk of having side effects or a greater chance of benefiting from certain medications. Individuals in this study will participate for roughly 9 months.
Interventions
OTHERDrug-Drug Interaction Profile
A profile based on genetic testing that shows information about how the participant's medications they are taking interact with each other.
OTHERDrug-Gene Interaction Profile
A profile based on genetic testing that shows information about how the participant's genes interact with/respond to certain medications they are taking.
OTHERStandard of Care
The standard treatment and prescribing for the participant's specific type of cancer.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult participants cared for by a participating provider at University of Chicago Medical Center. 2. Participants must be at least 18 years of age. 3. Participants prescribed 5 or medication medications and taking a perpetrator drug or a drug with actionable pharmacogenomic information.
Exclusion criteria
for Participants 1. Participants who have undergone, or are being actively considered for, liver or kidney transplantation. 2. Participation in another pharmacogenomic study. 3. Participants who have previously received genotyping from another source. 4. Inability to understand and give informed consent to participate. Inclusion of Women, Minorities, and Other Underrepresented Populations Individuals of all races and ethnic groups and genders are eligible for this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Rate of Drug-Drug Interactions and Drug-Gene Interactions Among Participants | 9 months | The change in the composite rate of drug-drug interactions (DDIs) and drug-gene interactions (DGIs) from baseline (at beginning of study) and after each intervention compared between all three arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants At High-Risk for Drug-Drug and Drug-Gene Interactions | 9 months | Reported as a percentage of total hospitalized participants |
| Strategy to Implement at Personalize Therapeutic Clinic (PTC) at Specific Sites Based on Available Mediators (PTC Partners) | 9 months | An implementation strategy for a site-specific Personalized Therapeutic Clinic (PTC) as assessed by evaluating which mediators and moderators who may be able to adopt PTC recommendations. |
| Rate of Hospitalizations | 9 months | The rate of hospitalizations among participants in all three arms as assessed by study notes/clinical record. |
| Rate of Emergency Department Visits | 9 months | Rate of emergency department visits among participants in all three arms as assessed by study notes/clinical record. |
| Rate of Reported Adverse Events as Assessed by Clinical Records | 9 months | Rate of reported adverse drug events among participants in all three arms as assessed by study notes/clinical record. |
| Changes in Participant Knowledge and Perceptions of the Personalized Therapeutic Clinic (PTC) as Assessed by Survey Results | 9 months | Changes in participant knowledge and perceptions of the PTC will be assessed using surveys administered at baseline and after the first post-PTC visit with their primary treating provider. |
| Changes in provider knowledge and perceptions of the Personalized Therapeutic Clinics (PTC) Assessed by Survey Results | 9 months | Changes in provider knowledge and perceptions of the PTC as assessed by survey collected from providers at baseline and at the end of study. |
Countries
United States
Contacts
CONTACTAndre Hall
PRINCIPAL_INVESTIGATORMark Ratain, MD
University of Chicago
Outcome results
None listed