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NCT Number: NCT05592665

PRO-VISION: Patient Reported Outcomes-Based Monitoring of VEGF-Inhibitor Side Effects in ONcology

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey questionnaire

Other

Study participants will complete several questionnaires/assessments via PRO-Core standardized email communication or via telephone with a study team member.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Dose modifications

    Time frame: Up to 3 years

    The proportion of patients who change the dose of VEGF TKI study treatment during the duration of treatment with VEGF TKI therapy.

  2. Dose interruption

    Time frame: Up to 3 years

    The proportion of patients who change the dose of VEGF TKI study treatment during the duration of treatment with VEGF TKI therapy.

  3. Hospital admissions

    Time frame: Up to 3 years

    The proportion of patients requiring hospitalization for a treatment-related side effect.

  4. Emergency department visits

    Time frame: Up to 3 years

    The proportion of patients requiring an emergency department visit for treatment-related adverse events.

  5. Duration of treatment on initial VEGF TKI dose

    Time frame: Up to 3 years

    Duration of treatment on initial VEGF TKI dose is defined from day 1 of treatment until the first dose reduction or dose interruption.

  6. Duration of treatment on VEGF TKI regimen

    Time frame: Up to 3 years

    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.

  7. Progression-free survival

    Time frame: Up to 3 years

    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.

  8. 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 (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.

  9. 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 (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.

  10. Health-related quality of life and symptom burden- Functional Assessment of Cancer Therapy Kidney System Index

    Time frame: Up to 3 years

    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.

  11. Treatment satisfaction

    Time frame: Up to 3 years

    The proportion of subjects satisfied or very satisfied with the weekly surveys to help manage side effects.

  12. VEGF TKI treatment adherence

    Time frame: Up to 3 years

    The median number of doses missed in a 4-week treatment period.

  13. Adherence to Patient Reported Outcome -based symptom

    Time frame: Up to 3 years

    Adherence to Patient Reported Outcome (PRO)-based symptom monitoring will be defined as the proportion of surveys completed per patient.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Doris Duke Charitable Foundation

Registry information

Acronym: PRO-VISION

Important dates

Study start
2022
Primary completion
2027
Study completion
2031
First posted
Oct 25, 2022
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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