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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-18

Study Completion Date

2031-01-16

Brief Summary

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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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Detailed Description

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Conditions

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Renal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patient Perspective

Study participants will complete several questionnaires/assessments related to adverse events and quality of life.

Group Type OTHER

Survey Questionnaire

Intervention Type OTHER

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

Interventions

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Survey Questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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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