Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma
- Conditions
- Metastatic Renal Cell Carcinoma
- Registration Number
- NCT04919122
- Lead Sponsor
- Duke University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
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Age 19 or over at time of informed consent.
-
Diagnosis of metastatic renal cell cancer (mRCC) with less than or equal to (≤) 6 weeks of first-line systemic therapy for mRCC.
- Prior surgery and radiation therapy are permitted.
- Prior neoadjuvant and adjuvant therapy for non-metastatic renal cell carcinoma are permitted.
- Patients currently not on therapy and being observed are permitted.
-
Evidence of signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
-
Ability to comply with completion of PROs
- Patients being treated for metastatic solid tumors other than mRCC are excluded. Non-cytotoxic oral agents for adjuvant or maintenance therapy of other cancers are permitted.
- Patients who are not intending to undergo follow up care at a study site within PCORnet
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in medication adherence as measured by patient report. baseline, every 3 months for 2 years, every 6 months for up to 36 months Patient's report their medication at each study visit.
Change in quality of life in mRCC patients receiving therapy as measured by FKSI-19 baseline, every 3 months for 2 years, every 6 months for up to 36 months The FKSI-19 is a questionnaire about the disease-related symptoms - physical, disease-related symptoms - emotional, treatment side-effects, and function/well-being.
Change in symptom burden in mRCC patients receiving therapy as measured by FACT-G baseline, every 3 months for 2 years, every 6 months for up to 36 months The FACT-G is a questionnaire about the physical well-being, social/family well-being, emotional well-being, and functional well-being.
Change in symptom burden in mRCC patients receiving therapy as measured by FKSI-19 baseline, every 3 months for 2 years, every 6 months for up to 36 months The FKSI-19 is a questionnaire about the disease-related symptoms - physical, disease-related symptoms - emotional, treatment side-effects, and function/well-being.
Change in quality of life in mRCC patients receiving therapy as measured by FACT-G baseline, every 3 months for 2 years, every 6 months for up to 36 months The FACT-G is a questionnaire about the physical well-being, social/family well-being, emotional well-being, and functional well-being.
- Secondary Outcome Measures
Name Time Method Health care resource utilization (including hospitalizations) Up to 36 months 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.
Overall survival (OS) of mRCC patients Up to 36 months 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.
Dose holds and dose interruptions Up to 36 months 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.
Concomitant glucocorticoid use Up to 36 months 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.
Subsequent line management choice(s) Up to 36 months 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).
Dosing (starting dose, dose intensity, ending dose) Up to 36 months 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.
Work Productivity and Activity Impairment (WAPI) questionnaire Up to 36 months 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 on treatment Up to 36 months 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.
First line management choice(s) Up to 36 months 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 to next treatment Up to 36 months 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.
Early discontinuation of one agent of a combination Up to 36 months 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.
Trial Locations
- Locations (11)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
State University of Iowa
🇺🇸Iowa City, Iowa, United States
Geisinger Clinic
🇺🇸Danville, Pennsylvania, United States
The Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
The University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
The Medical College of Wisconsin, Inc.
🇺🇸Milwaukee, Wisconsin, United States
The Regents of the University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States