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Software Monitoring of Treatment Related Toxicities in Advanced Renal Cell Carcinoma

Primary Purpose

Advanced Renal Cell Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carevive software
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Advanced Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rochester - Wilmot Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Use of Carevive software

Arm Description

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

Outcomes

Primary Outcome Measures

Carevive Survey Usage Rates
Carevive software will track subject compliance with survey logins and whether they access the generated care plans. The percentage of times logged in out of the number of study recommended logins will be tabulated. Also, the percentage of times a careplan was accessed out of the number of times it was offered will be determined. To determine the practicality of the intervention, by analyzing the reasons why subjects fail to self-report treatment-related toxicities or utilize software generated care plans after enrollment. To assess the acceptability of this intervention with validated patient reported usability scores of the software. To determine potential implementation obstacles of the intervention, by assessing the reasons eligible study candidates decline participation.
Reasons Participants Do Not Complete Survey or Utilize Care Plans
After missing a survey, subjects will be asked the reason at their following login. The reason provided will be sorted into pre-specified categories and presented as a percentage.
Average Usability Score Using the Software Usability Scoring System
At the 48 week time point or at the point of subject withdrawal from study, they will be asked to take the System Usability Scale. The survey provides us with a score of between 0 and 40 which is then multiplied by 2.5 to convert to a scale of 0 to 100. A SUS score above a 68 would be considered above average and anything below 68 is below average.
Reasons for Declining Study Participation
If a subject declines to participation in the study, he/she will be asked to provide a reason for declination. If willing, we will have them sign a separate consent with a space to write in their reason. The reason provided will be sorted into pre-specified categories and presented as a percentage.

Secondary Outcome Measures

Patient Reported Toxicities Using PRO-CTCAE Questions
Patient reported toxicity data will be collected via Carevive surveys weekly for the first 12 weeks and then every other week for another 36 weeks. We will not deliver the PRO-CTCAE in its entirety but will specifically ask about the following common toxicities that are experienced with oral targeted therapy and immunotherapy: diarrhea, nausea, vomiting, fatigue, hand/foot syndrome, rash, abdominal pain, anorexia, mouth sores, cough and shortness of breath.
Clinician Reported Toxicities Using CTCAE
Toxicities will also be formally assessed in-office every 3-4 months using CTCAE scoring. The categories chosen are common toxicities that occur with oral targeted therapy and immunotherapy: diarrhea, nausea, vomiting, fatigue, hand/foot syndrome, rash, abdominal pain, appetite, mouth sores, cough and shortness of breath
Quality of Life Determination Using the FKSI-DRS Survey
Subjects will be asked to fill out the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) at baseline and approximately every 3 months in-office.
Distress Level Using the NCCN Distress Thermometer
The subject will be asked to rate their distress level in-office using the NCCN Distress Thermometer, which is a 1 to 10 numerical scale. This will be delivered during routine office visits approximately every 3 months on a tablet.
• Health Care Utilization Assessment By Quantification of Health Care Visits or Hospitalizations
Health care utilization will be self-reported by the subject through CareVive software monthly, in addition at the end of the study or at time of withdrawal, a search of the electronic medical record will be performed to determine the number of calls made to oncology care providers and the number of visits to the oncologist during the study period.

Full Information

First Posted
July 18, 2017
Last Updated
November 7, 2022
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT03229083
Brief Title
Software Monitoring of Treatment Related Toxicities in Advanced Renal Cell Carcinoma
Official Title
Monitoring of Treatment Related Toxicities From Oral Targeted Agents and Immunotherapy Among Patients With Advanced Renal Cell Carcinoma (RCC) Using Carevive Software, a Single-Arm Phase II Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2019 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Renal Cell Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Use of Carevive software
Arm Type
Experimental
Arm Description
Reporting and management of side effects from oral targeted therapy or immunotherapy, through Carevive software, in patients who have advanced Renal Cell Carcinoma (RCC).
Intervention Type
Other
Intervention Name(s)
Carevive software
Intervention Description
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.
Primary Outcome Measure Information:
Title
Carevive Survey Usage Rates
Description
Carevive software will track subject compliance with survey logins and whether they access the generated care plans. The percentage of times logged in out of the number of study recommended logins will be tabulated. Also, the percentage of times a careplan was accessed out of the number of times it was offered will be determined. To determine the practicality of the intervention, by analyzing the reasons why subjects fail to self-report treatment-related toxicities or utilize software generated care plans after enrollment. To assess the acceptability of this intervention with validated patient reported usability scores of the software. To determine potential implementation obstacles of the intervention, by assessing the reasons eligible study candidates decline participation.
Time Frame
48 weeks
Title
Reasons Participants Do Not Complete Survey or Utilize Care Plans
Description
After missing a survey, subjects will be asked the reason at their following login. The reason provided will be sorted into pre-specified categories and presented as a percentage.
Time Frame
48 weeks
Title
Average Usability Score Using the Software Usability Scoring System
Description
At the 48 week time point or at the point of subject withdrawal from study, they will be asked to take the System Usability Scale. The survey provides us with a score of between 0 and 40 which is then multiplied by 2.5 to convert to a scale of 0 to 100. A SUS score above a 68 would be considered above average and anything below 68 is below average.
Time Frame
48 weeks
Title
Reasons for Declining Study Participation
Description
If a subject declines to participation in the study, he/she will be asked to provide a reason for declination. If willing, we will have them sign a separate consent with a space to write in their reason. The reason provided will be sorted into pre-specified categories and presented as a percentage.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Patient Reported Toxicities Using PRO-CTCAE Questions
Description
Patient reported toxicity data will be collected via Carevive surveys weekly for the first 12 weeks and then every other week for another 36 weeks. We will not deliver the PRO-CTCAE in its entirety but will specifically ask about the following common toxicities that are experienced with oral targeted therapy and immunotherapy: diarrhea, nausea, vomiting, fatigue, hand/foot syndrome, rash, abdominal pain, anorexia, mouth sores, cough and shortness of breath.
Time Frame
48 weeks
Title
Clinician Reported Toxicities Using CTCAE
Description
Toxicities will also be formally assessed in-office every 3-4 months using CTCAE scoring. The categories chosen are common toxicities that occur with oral targeted therapy and immunotherapy: diarrhea, nausea, vomiting, fatigue, hand/foot syndrome, rash, abdominal pain, appetite, mouth sores, cough and shortness of breath
Time Frame
48 weeks
Title
Quality of Life Determination Using the FKSI-DRS Survey
Description
Subjects will be asked to fill out the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) at baseline and approximately every 3 months in-office.
Time Frame
48 weeks
Title
Distress Level Using the NCCN Distress Thermometer
Description
The subject will be asked to rate their distress level in-office using the NCCN Distress Thermometer, which is a 1 to 10 numerical scale. This will be delivered during routine office visits approximately every 3 months on a tablet.
Time Frame
48 weeks
Title
• Health Care Utilization Assessment By Quantification of Health Care Visits or Hospitalizations
Description
Health care utilization will be self-reported by the subject through CareVive software monthly, in addition at the end of the study or at time of withdrawal, a search of the electronic medical record will be performed to determine the number of calls made to oncology care providers and the number of visits to the oncologist during the study period.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Rochester - Wilmot Cancer Institute
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Gerbino
Phone
585-273-2605
Email
nicholas_gerbino@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Rachel Turner
Email
Rachael_Turner@URMC.Rochester.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Software Monitoring of Treatment Related Toxicities in Advanced Renal Cell Carcinoma

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