Clinical trial NCT05592665: PRO-VISION: Patient Reported Outcomes-Based Monitoring of VEGF-Inhibitor Side Effects in ONcology
Official title: PRO-VISION: Patient Reported Outcomes-Based Monitoring of VEGF-Inhibitor Side Effects in ONcology
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Renal Cell Carcinoma
Keywords: patient reported outcomes
vascular endothelial growth factor
quality of life
adverse effects
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2022-10-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate how collecting information about treatment-related side effects directly from patients can help manage the side effects associated with certain oral chemotherapies. This study is specifically investigating this approach in patients taking oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) for metastatic renal cell carcinoma (mRCC).

Participants in this study will receive a survey via email or telephone once a week while receiving treatment with a VEGFR TKI. The survey will ask about symptoms such as nausea or fatigue and overall quality of life. This survey should take no more than 15 minutes to complete.

The survey will be sent directly to the oncology care team. Participants will receive a follow-up phone call or message from the team when participants have new or worsening symptoms. The participants will continue to receive surveys for as long as they are receiving a VEGF TKI treatment.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18 years or older
* Histologically confirmed renal cell carcinoma requiring treatment with VEGF TKI.
* Patients may be receiving other concurrent cancer-directed therapy such as immune checkpoint inhibitors.
* English or Spanish speaking
* Ability to complete PRO surveys (i.e. ability to read/write or access to telephone or internet)
* Willing and able to meet all study requirements

Exclusion Criteria:

All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.

• Inability for any reason to complete PRO surveys

Primary outcomes:
measure: Relative dose intensity
timeFrame: Up to 3 years
Secondary outcomes:
measure: Dose modifications
timeFrame: Up to 3 years
measure: Dose interruption
timeFrame: Up to 3 years
measure: Hospital admissions
timeFrame: Up to 3 years
measure: Emergency department visits
timeFrame: Up to 3 years
measure: Duration of treatment on initial VEGF TKI dose
timeFrame: Up to 3 years
measure: Duration of treatment on VEGF TKI regimen
timeFrame: Up to 3 years
measure: Progression-free survival
timeFrame: Up to 3 years
measure: Health-related quality of life and symptom burden -Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events
timeFrame: Up to 3 years
measure: Health-related quality of life and symptom burden - EuroQol-5 Dimension (EQ-5D-5L) questionnaire.
timeFrame: Up to 3 years
measure: Health-related quality of life and symptom burden- Functional Assessment of Cancer Therapy Kidney System Index
timeFrame: Up to 3 years
measure: Treatment satisfaction
timeFrame: Up to 3 years
measure: VEGF TKI treatment adherence
timeFrame: Up to 3 years
measure: Adherence to Patient Reported Outcome -based symptom
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Tracy Rose
role: PRINCIPAL_INVESTIGATOR
References: