Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma (ODYSSEY RCC)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 468
- Locations
- 14
- Primary Endpoint
- Change in medication adherence as measured by patient report.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 19 or over at time of informed consent.
- •Diagnosis of metastatic renal cell cancer (mRCC) with less than or equal to (≤) 3 months of first-line systemic therapy or less than or equal to (≤) 3 months of second-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
Exclusion Criteria
- •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
Arms & Interventions
Patients with mRCC with ≤ 3 mos of 1L or 2L systemic therapy
This is an observational cohort.
- mRCC = metastatic renal cell cancer
- 1L=first-line systemic therapy
- 2L=second-line systemic therapy
Outcomes
Primary Outcomes
Change in medication adherence as measured by patient report.
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Health care resource utilization (including hospitalizations)(Up to 36 months)
- Overall survival (OS) of mRCC patients(Up to 36 months)
- Dose holds and dose interruptions(Up to 36 months)
- Concomitant glucocorticoid use(Up to 36 months)
- Subsequent line management choice(s)(Up to 36 months)
- Dosing (starting dose, dose intensity, ending dose)(Up to 36 months)
- Work Productivity and Activity Impairment (WAPI) questionnaire(Up to 36 months)
- Time on treatment(Up to 36 months)
- First line management choice(s)(Up to 36 months)
- Time to next treatment(Up to 36 months)
- Early discontinuation of one agent of a combination(Up to 36 months)