Software Monitoring for Kidney Cancer Side Effects

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Must be taking: Oral targeted, Immunotherapy

Disqualifiers: Breast-feeding, No internet, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special software called Carevive (also known as Carevive Systems or Carevive Platform) can assist people with advanced kidney cancer in managing treatment side effects. It will evaluate how the software impacts issues like quality of life and adherence to medication plans. The trial seeks participants with metastatic renal cell carcinoma (a type of kidney cancer that has spread) who are beginning oral or immune-based therapies. Participants should be able to use a smartphone or email to receive updates and support from the software. As an unphased trial, this study provides a unique opportunity to explore innovative ways to enhance the treatment experience.

Do I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current treatment, as the trial focuses on monitoring side effects of new therapies.

What prior data suggests that the Carevive software is safe for monitoring kidney cancer side effects?

Research shows that hospitals and clinics use Carevive software to help manage side effects from cancer treatment. This software tracks any issues patients might experience and suggests self-care strategies.

No evidence indicates that Carevive software can cause harm, as it functions like a digital assistant by monitoring health rather than acting as a drug or treatment. Users have not reported any negative effects from using this software.

In summary, the software is safe and aids in managing side effects rather than causing them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Carevive software for kidney cancer because it offers a new way to monitor and manage side effects from treatment. Unlike traditional approaches that rely heavily on in-person visits and verbal reports, this software allows real-time reporting and management of side effects remotely. This can lead to faster interventions and potentially better outcomes for patients with advanced Renal Cell Carcinoma (RCC). The ability to track side effects through a digital platform is a step forward in personalized and efficient cancer care.

What evidence suggests that the Carevive software is effective for managing side effects in kidney cancer patients?

Research shows that Carevive software improves the treatment experience for cancer patients by tracking side effects and suggesting management strategies. Studies have found that using Carevive can enhance patients' quality of life and survival rates. In this trial, participants will use Carevive software to manage side effects from oral targeted therapy or immunotherapy for advanced kidney cancer. Although specific data on its effectiveness for advanced kidney cancer is still being collected, its success in other cancer treatments is encouraging. This software aims to help manage side effects and enhance overall care for those receiving treatment. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with metastatic renal cell carcinoma who are starting oral targeted therapy or immunotherapy. They must be able to consent, read English, have an email or smart device for texts, and visit the Wilmot Cancer Center every 3-4 months. Breastfeeding women and those without internet access can't join.

Inclusion Criteria

My oncologist at Wilmot Cancer Center recommends oral targeted therapy or immunotherapy for my advanced kidney cancer.

I have kidney cancer that has spread, confirmed by tests.

Proficient in the English language and self-reports as literate

Exclusion Criteria

Subjects who were on the study previously will not be allowed to re-enroll in the event of a treatment change

I cannot visit the Wilmot Cancer Center every 3-4 months for check-ups.

Women cannot be breast-feeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use Carevive software to report and manage side effects from oral targeted therapy or immunotherapy

48 weeks

Weekly surveys for the first 12 weeks, then bi-weekly for 36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Carevive software

Trial Overview

The study tests if Carevive software can effectively monitor treatment-related toxicities in patients with advanced kidney cancer. It aims to see if it's feasible to use this software to create self-care plans based on reported symptoms, affecting quality of life and medication adherence.

How Is the Trial Designed?

Group I: Use of Carevive software Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The Medical Care Continuity (MCC) system, which includes video consultations and monitoring, was well-received by cancer outpatients, with 98% of participants reporting positive opinions about its usefulness.

The system effectively reduced unnecessary hospital admissions by approximately 2.2 per month, demonstrating its potential to enhance patient management and provide continuous medical support during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Medical Care Continuity (MCC) project. A pilot study of video-assisted home care within the eTEN European Community program. The Italian experience. Formica, V., Fossile, E., Pellegrino, R., et al.[2021]

The North Central Cancer Treatment Group developed a real-time toxicity reporting system to enhance the monitoring of severe side effects in NCI-sponsored clinical trials, aiming to improve patient safety.

This system has been effective in monitoring phase II and III trials, such as the N9741 study on advanced colorectal cancer, allowing for timely modifications to ongoing clinical trials based on reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early detection of toxicity and adjustment of ongoing clinical trials: the history and performance of the North Central Cancer Treatment Group's real-time toxicity monitoring program. Goldberg, RM., Sargent, DJ., Morton, RF., et al.[2016]

The Advanced Symptom Management System (ASyMS) significantly reduced symptom burden in patients undergoing adjuvant chemotherapy, keeping their symptoms at pre-treatment levels, while those receiving standard care experienced increased symptoms throughout treatment.

Patients using ASyMS reported better quality of life and lower anxiety levels compared to the control group, indicating that remote monitoring can enhance patient support during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART). Maguire, R., McCann, L., Kotronoulas, G., et al.[2021]

A web-based interface (WBI) for patient symptom self-reporting during chemoradiation therapy was found to be feasible and well-received, with 92% of patients reporting easy access to the surveys.

Despite high satisfaction, survey fatigue was noted, as 58% of patients felt the surveys were too long or frequent, suggesting a need for a more patient-centered approach to improve engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Symptom Monitoring With Patient-Reported Outcomes During Definitive Radiation Therapy With Chemotherapy (SYMPATHY): A Prospective Single-Center Phase 1 Study. Ma, TM., Yang, T., Philipson, R., et al.[2023]

The review identified 41 distinct electronic symptom reporting systems for cancer patients, highlighting features such as remote monitoring by health professionals and patient access to symptom tracking, which can enhance patient engagement and management of treatment side effects.

Despite the potential benefits of these systems on patient-centered outcomes, the lack of standardized methods for measuring engagement and outcomes across studies makes it challenging to draw definitive conclusions about their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Systems for Patients to Report and Manage Side Effects of Cancer Treatment: Systematic Review. Warrington, L., Absolom, K., Conner, M., et al.[2023]

The web application BijKanker was well-received by patients, with 61% completing the initial questionnaire and 40% providing feedback after four months, indicating a positive user experience in reporting side effects during cancer treatment.

Patients reported a total of 1661 side effects, highlighting the application's effectiveness in capturing patient-reported outcomes, which can enhance communication with healthcare providers and improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of an online application for reporting the burden of side effects in cancer patients. van Eenbergen, MC., van den Hurk, C., Mols, F., et al.[2021]

The study aims to evaluate a smartphone application designed for real-time reporting of adverse events in cancer treatments, which could enhance early detection and management of side effects, ultimately improving patient safety and treatment outcomes.

The trial will involve 66 patients over six months, assessing the feasibility of the app and comparing the quality of life and therapy doses between those using the app and those receiving standard care, highlighting the importance of patient-reported symptoms in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. Kestler, AMR., Kühlwein, SD., Kraus, JM., et al.[2021]

An Internet-based 'Patient Support System' was developed to help patients undergoing outpatient chemotherapy report and manage side effects, which was tested in a trial with 8 patients.

The system effectively allowed medical staff to monitor side effects in real-time, helping patients manage their symptoms and maintain their quality of life during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Support System for Breast Cancer Patients--Managing Side Effects through an Internet-Based System. Okuyama, H., Kato, Y., Handa, S., et al.[2022]

The telephone-linked care (TLC) system was successfully used by 27 cancer patients to report daily chemotherapy-related symptoms, demonstrating high patient satisfaction and ease of use.

The system effectively generated alerts for healthcare providers when patients reported severe symptoms, indicating its potential to enhance symptom monitoring and improve communication in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-linked care for cancer symptom monitoring: a pilot study. Mooney, KH., Beck, SL., Friedman, RH., et al.[2022]

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