20 Participants Needed

Software Monitoring for Kidney Cancer Side Effects

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Rochester
Must be taking: Oral targeted, Immunotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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 safety data exists for the Carevive software in monitoring kidney cancer treatment side effects?

The provided research does not directly mention the Carevive software or its safety data. However, it discusses various electronic systems and methods for monitoring cancer treatment side effects, including real-time toxicity reporting and patient-reported outcomes. These systems aim to improve patient safety by early detection and management of side effects, which could be relevant to the goals of the Carevive software.12345

Is the treatment in the trial 'Software Monitoring for Kidney Cancer Side Effects' a promising treatment?

Yes, the treatment is promising because it uses electronic systems to help patients manage side effects from home, improving their quality of life and allowing them to better communicate with healthcare providers.26789

What data supports the idea that Software Monitoring for Kidney Cancer Side Effects is an effective treatment?

The available research shows that electronic systems for reporting and managing side effects of cancer treatment can be effective. For example, a study on an Internet-based system for breast cancer patients demonstrated that it helped patients manage side effects and maintain their quality of life. Patients could communicate symptoms from home, which allowed medical staff to monitor and confirm side effects, leading to better self-management. This suggests that similar software monitoring systems, like Carevive, could be effective for kidney cancer patients by helping them manage side effects and improve their overall treatment experience.12569

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
See 3 more

Exclusion Criteria

I cannot visit the Wilmot Cancer Center every 3-4 months for check-ups.
Subjects who were on the study previously will not be allowed to re-enroll in the event of a treatment change
Women cannot be breast-feeding
See 1 more

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?
1Treatment groups
Experimental Treatment
Group I: Use of Carevive softwareExperimental Treatment1 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).

Find a Clinic Near You

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 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.
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 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.
Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART).Maguire, R., McCann, L., Kotronoulas, G., et al.[2021]
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.
Electronic Systems for Patients to Report and Manage Side Effects of Cancer Treatment: Systematic Review.Warrington, L., Absolom, K., Conner, M., et al.[2023]

Citations

Usability of an online application for reporting the burden of side effects in cancer patients. [2021]
Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART). [2021]
Electronic Systems for Patients to Report and Manage Side Effects of Cancer Treatment: Systematic Review. [2023]
Web-Based Symptom Monitoring With Patient-Reported Outcomes During Definitive Radiation Therapy With Chemotherapy (SYMPATHY): A Prospective Single-Center Phase 1 Study. [2023]
Development of Support System for Breast Cancer Patients--Managing Side Effects through an Internet-Based System. [2022]
Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. [2021]
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. [2016]
Telephone-linked care for cancer symptom monitoring: a pilot study. [2022]
The Medical Care Continuity (MCC) project. A pilot study of video-assisted home care within the eTEN European Community program. The Italian experience. [2021]
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