Renal Cell CarcinomaPRO-VISIONNCT05592665
PRO-VISION: Patient Reported Outcomes-Based Monitoring of VEGF-Inhibitor Side Effects in ONcology
A study testing Survey Questionnaire in people with Renal Cell Carcinoma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Survey Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2022to 16 Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Inability for any reason to complete PRO surveys
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
About this study
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.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Survey Questionnaire
- Keywords
- patient reported outcomes, vascular endothelial growth factor, quality of life, adverse effects
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey QuestionnaireOther
Study participants will complete several questionnaires/assessments via PRO-Core standardized email communication or via telephone with a study team member.
| Study group | Role | What they receive |
|---|---|---|
| Patient Perspective | Other | Study participants will complete several questionnaires/assessments related to adverse events and quality of life. Receives: Other: Survey Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative dose intensity
Relative dose intensity is defined as the actual treatment dose taken per unit of time divided by the standard or initially prescribed dose per unit during the duration of treatment with VEGF TKI.
Measured: Up to 3 years
Secondary outcomes (13)
Dose modifications
The proportion of patients who change the dose of VEGF TKI study treatment during the duration of treatment with VEGF TKI therapy.
Measured: Up to 3 years
Dose interruption
The proportion of patients who change the dose of VEGF TKI study treatment during the duration of treatment with VEGF TKI therapy.
Measured: Up to 3 years
Hospital admissions
The proportion of patients requiring hospitalization for a treatment-related side effect.
Measured: Up to 3 years
Emergency department visits
The proportion of patients requiring an emergency department visit for treatment-related adverse events.
Measured: Up to 3 years
Duration of treatment on initial VEGF TKI dose
Duration of treatment on initial VEGF TKI dose is defined from day 1 of treatment until the first dose reduction or dose interruption.
Measured: Up to 3 years
Duration of treatment on VEGF TKI regimen
Duration of treatment on VEGF TKI regimen is defined from day 1 of treatment until the last dose of VEGF TKI treatment at any dose.
Measured: Up to 3 years
Progression-free survival
Progression-free survival is defined as day 1 of treatment until progression of disease or death from any cause; patients will be censored at the time of new treatment initiation if progression has not occurred.
Measured: Up to 3 years
Health-related quality of life and symptom burden -Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events
Health-related quality of life (HRQoL) and symptom burden will be assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire.
The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities that include pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient perspective.
Measured: Up to 3 years
Health-related quality of life and symptom burden - EuroQol-5 Dimension (EQ-5D-5L) questionnaire.
Health-related quality of life (HRQoL) and symptom burden will be assessed using the EuroQol-5 Dimension (EQ-5D-5L) questionnaire.
The EQ-5D-5L is a QoL assessment that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels ranging from no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5) to extreme problems.
Measured: Up to 3 years
Health-related quality of life and symptom burden- Functional Assessment of Cancer Therapy Kidney System Index
Health-related quality of life (HRQoL) and symptom burden will be assessed using the Functional Assessment of Cancer Therapy Kidney System Index (FKSI-19) scores.
The FKSI-19 is a 19-item questionnaire specific to kidney cancer. The items include disease-related symptoms(both physical and emotional), as well as treatment side-effects, and function/well-being. The questions are reported on a Likert scale as not at all, a little bit, somewhat, quite a bit, or very much. The questions address lack of energy, pain, weight loss, fatigue, shortness of breath, fevers, bone pain, cough, weakness, blood in urine, appetite, sleep, worry about the condition, nausea, diarrhea, bothered by side effects, ability to work, ability to enjoy life and level of content with the quality of life.
Measured: Up to 3 years
Treatment satisfaction
The proportion of subjects satisfied or very satisfied with the weekly surveys to help manage side effects.
Measured: Up to 3 years
VEGF TKI treatment adherence
The median number of doses missed in a 4-week treatment period.
Measured: Up to 3 years
Adherence to Patient Reported Outcome -based symptom
Adherence to Patient Reported Outcome (PRO)-based symptom monitoring will be defined as the proportion of surveys completed per patient.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start18 Mar 2022
- Primary completion16 Jan 2027 (estimated)
- Study completion16 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Tracy Rose, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592665
- Sponsor's protocol ID
- LCCC2126
- Acronym
- PRO-VISION
- Status last verified
- May 2026
- First submitted
- 20 Sep 2022
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRO-VISION: Patient Reported Outcomes-Based Monitoring of VEGF-Inhibitor Side Effects in ONcology
- ClinicalTrials.gov ID
- NCT05592665
- Acronym / sponsor ID
- PRO-VISION / LCCC2126
- Conditions
- Renal Cell Carcinoma
- Keywords
- patient reported outcomes, vascular endothelial growth factor, quality of life, adverse effects
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 16 Jan 2027 (estimated)
- Study completion
- 16 Jan 2031 (estimated)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Perspective | Other | Other: Survey QuestionnaireStudy participants will complete several questionnaires/assessments related to adverse events and quality of life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Inability for any reason to complete PRO surveys
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey QuestionnaireStudy participants will complete several questionnaires/assessments via PRO-Core standardized email communication or via telephone with a study team member. | Other | Patient Perspective |
Primary outcome
Relative dose intensity
Time frame: Up to 3 years
Relative dose intensity is defined as the actual treatment dose taken per unit of time divided by the standard or initially prescribed dose per unit during the duration of treatment with VEGF TKI.
13 secondary outcomes
Dose modifications
Time frame: Up to 3 years
Dose interruption
Time frame: Up to 3 years
Hospital admissions
Time frame: Up to 3 years
Emergency department visits
Time frame: Up to 3 years
Duration of treatment on initial VEGF TKI dose
Time frame: Up to 3 years
Duration of treatment on VEGF TKI regimen
Time frame: Up to 3 years
Progression-free survival
Time frame: Up to 3 years
Health-related quality of life and symptom burden -Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events
Time frame: Up to 3 years
Health-related quality of life and symptom burden - EuroQol-5 Dimension (EQ-5D-5L) questionnaire.
Time frame: Up to 3 years
Health-related quality of life and symptom burden- Functional Assessment of Cancer Therapy Kidney System Index
Time frame: Up to 3 years
Treatment satisfaction
Time frame: Up to 3 years
VEGF TKI treatment adherence
Time frame: Up to 3 years
Adherence to Patient Reported Outcome -based symptom
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy Rose principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey Questionnaire in people with Renal Cell Carcinoma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative dose intensity (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.