Software Monitoring of Treatment Related Toxicities in Advanced Renal Cell Carcinoma

NCT ID: NCT03229083

Last Updated: 2025-02-28

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-24

Study Completion Date

2025-02-14

Brief Summary

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To determine if Carevive software, which monitors treatment-related toxicities and then generates self-care management plans for these symptoms, will be feasible to implement among patients with metastatic renal cell carcinoma (RCC). Additionally for collection of preliminary data on treatment-related toxicities, quality of life, distress level, and drug adherence.

Detailed Description

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Conditions

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Advanced Renal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Use of Carevive software

Reporting and management of side effects from oral targeted therapy or immunotherapy, through Carevive software, in patients who have advanced Renal Cell Carcinoma (RCC).

Group Type EXPERIMENTAL

Carevive software

Intervention Type OTHER

In this study, Carevive will deliver a link to subjects so that an online survey can be completed. The survey will occur weekly for the first 12 weeks of the study and will be spaced out to every other week thereafter. The questions will mostly focus on side effects from their cancer therapy, as well as a few questions about drug compliance and healthcare utilization. After completion of the survey, the subject will be given a care plan with at home self-management options for drug-related toxicities.

Interventions

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Carevive software

In this study, Carevive will deliver a link to subjects so that an online survey can be completed. The survey will occur weekly for the first 12 weeks of the study and will be spaced out to every other week thereafter. The questions will mostly focus on side effects from their cancer therapy, as well as a few questions about drug compliance and healthcare utilization. After completion of the survey, the subject will be given a care plan with at home self-management options for drug-related toxicities.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of histologically confirmed renal cell carcinoma of any subtype with either pathological or radiographic evidence of metastatic disease
* Greater than 18 years of age
* A participating Wilmot Cancer Center oncologist has determined that candidate should be started on either oral targeted therapy or immunotherapy for treatment of their advanced RCC; this can be for first-line or any subsequent line therapy
* Able to provide written informed consent
* Proficient in the English language and self-reports as literate
* Must have an active email address or access to a smart device on which text messages can be received

Exclusion Criteria

* Women cannot be breast-feeding
* Does not have regular access to the internet
* Unable to come to the Wilmot Cancer Center for appointments every 3-4 months for routine visits with their primary oncologist
* Subjects who were on the study previously will not be allowed to re-enroll in the event of a treatment change
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Chunkit Fung

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rochester - Wilmot Cancer Institute

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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UG1CA189961

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UGUK 17036

Identifier Type: -

Identifier Source: org_study_id

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