ODYSSEY RCC is a prospective, observational Phase IV study is to understand the cancer management and health-related quality of life in patients with mRCC in routine real-world clinical practice in the United States, including both community and academic treatment settings.
This trial is a prospective, observational Phase IV study is to understand the cancer management and health-related quality of life in patients with mRCC in routine real-world clinical practice in the United States, including both community and academic treatment settings. Primarily, the study will evaluate patient experience through collection of patient reported outcomes (PROs). The study will also collect and assess information on the therapies used such as first-line treatment selection, treatment sequence and duration, the drivers of physician selection of particular agents, and discontinuation of therapies. The primary objective is to determine distinct patterns of change in the quality of life and symptom burden in mRCC patients receiving therapy. Patients will be identified and undergo consent and baseline assessments, including research blood collection and processing, by the study site team, this baseline visit will be their only clinic visits per protocol. All other visits are standard of care visits and outside the scope of the study. Subsequent follow up with be coordinated centrally by DCRI. Additional clinic data will be obtained via PCORnet data pull and Medicare claims. Patient reported outcomes, quality of life and medications data will be obtained via the DCRI Call Center through follow-up phone interviews.
Study Type
OBSERVATIONAL
Enrollment
468
State University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Ochsner Clinic Foundation d/b/a Ochsner Health
Change in medication adherence as measured by patient report.
Patient's report their medication at each study visit.
Time frame: baseline, every 3 months for 2 years, every 6 months for up to 36 months
Change in quality of life in mRCC patients receiving therapy as measured by FKSI-19
The FKSI-19 is a questionnaire about the disease-related symptoms - physical, disease-related symptoms - emotional, treatment side-effects, and function/well-being.
Time frame: baseline, every 3 months for 2 years, every 6 months for up to 36 months
Change in symptom burden in mRCC patients receiving therapy as measured by FKSI-19
The FKSI-19 is a questionnaire about the disease-related symptoms - physical, disease-related symptoms - emotional, treatment side-effects, and function/well-being.
Time frame: baseline, every 3 months for 2 years, every 6 months for up to 36 months
Change in quality of life in mRCC patients receiving therapy as measured by FACT-G
The FACT-G is a questionnaire about the physical well-being, social/family well-being, emotional well-being, and functional well-being.
Time frame: baseline, every 3 months for 2 years, every 6 months for up to 36 months
Change in symptom burden in mRCC patients receiving therapy as measured by FACT-G
The FACT-G is a questionnaire about the physical well-being, social/family well-being, emotional well-being, and functional well-being.
Time frame: baseline, every 3 months for 2 years, every 6 months for up to 36 months
First line management choice(s)
A composite of REDCap data entry by sites, PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on line management choice(s).
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New Orleans, Louisiana, United States
The Johns Hopkins University
Baltimore, Maryland, United States
The Regents of the University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Geisinger Clinic
Danville, Pennsylvania, United States
...and 4 more locations
Time frame: Up to 36 months
Subsequent line management choice(s)
A composite of REDCap data entry by sites, PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on line management choice(s).
Time frame: Up to 36 months
Dosing (starting dose, dose intensity, ending dose)
A composite of REDCap data entry by sites, PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on dosing.
Time frame: Up to 36 months
Dose holds and dose interruptions
A composite of PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on dosing holds and interruptions.
Time frame: Up to 36 months
Time on treatment
A composite of REDCap data entry by sites, PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on time on treatment.
Time frame: Up to 36 months
Time to next treatment
A composite of PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on time to next treatment.
Time frame: Up to 36 months
Early discontinuation of one agent of a combination
A composite of PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on early discontinuation of one agent of a combination.
Time frame: Up to 36 months
Concomitant glucocorticoid use
A composite of PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on concomitant glucocorticoid use.
Time frame: Up to 36 months
Work Productivity and Activity Impairment (WAPI) questionnaire
A composite of REDCap data entry by sites, PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on the WAPI questionnaire.
Time frame: Up to 36 months
Health care resource utilization (including hospitalizations)
A composite of PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on health care resource utilization.
Time frame: Up to 36 months
Overall survival (OS) of mRCC patients
A composite of various starting points (time of diagnosis of metastatic disease, time of study entry and time of starting systemic therapy) to avoid lead-time bias.
Time frame: Up to 36 months