Digital Remote Monitoring for Cancer Immunotherapy
(IRIS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how wearable devices and self-reported symptoms can help monitor patients undergoing immunotherapy for advanced melanoma, a type of skin cancer. The researchers aim to determine if digital monitoring improves symptom management and keeps patients more engaged with their care team. Participants might wear a Fitbit to track activity, heart rate, and sleep, and regularly report symptoms through a smartphone app. This digital remote monitoring intervention is designed to enhance patient care. Ideal candidates have just started immune therapy at UPMC Hillman Cancer Center, speak English, and own a smartphone. As an unphased trial, this study offers patients the chance to contribute to innovative research that could improve future cancer care.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on monitoring symptoms and quality of life during immunotherapy, so you may not need to change your current medication routine.
What prior data suggests that this digital remote monitoring intervention is safe for cancer patients?
Research has shown that wearable devices are generally safe for cancer patients. These devices help track physical activity and vital signs like heart rate and breathing. One study found that patients using these devices often developed healthier habits.
Another review found that wearables can help predict how well patients might respond to treatment. They also assist in managing symptoms by sending alerts if something seems unusual, which can lead to fewer emergency visits and better overall care.
Patients reported that using these devices was easy and did not cause any major issues. They appreciated how the devices helped them stay connected with their healthcare team.
Overall, wearable devices used for remote monitoring are considered safe and well-tolerated. They offer a convenient way to monitor health from home.12345Why are researchers excited about this trial?
Researchers are excited about the digital remote monitoring intervention for cancer immunotherapy because it offers a novel way to track and manage treatment-related side effects. Unlike traditional care, which may rely on in-person visits and patient self-reporting, this approach uses a Fitbit activity tracker to continuously monitor vital signs like heart rate, sleep, and activity levels. This data, combined with weekly electronic symptom reports, helps detect immune-related adverse events more quickly and accurately. By leveraging technology for real-time monitoring, this method aims to improve patient outcomes and personalize care in ways traditional methods can't.
What evidence suggests that this digital remote monitoring intervention is effective for cancer immunotherapy?
Research has shown that digital tools for health monitoring can greatly enhance the quality of life for cancer patients. In this trial, participants in the digital remote monitoring group will use devices like Fitbits to track vital health signs, such as heart rate and breathing rate, which are crucial for cancer care. Studies suggest that data from these devices can lead to better health outcomes for cancer patients. Meanwhile, the usual care group will not use these digital tools but will complete standard assessments. Overall, technology for symptom and health monitoring can significantly aid in managing treatment and improving patient well-being.45678
Who Is on the Research Team?
Carissa A Low
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for individuals with skin cancer, specifically melanoma, who are undergoing immunotherapy. Participants should be willing to use wearable devices and complete questionnaires about their health and quality of life. Details on specific inclusion or exclusion criteria were not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete baseline questionnaires and Short Physical Performance Battery (SPPB) as feasible
Treatment
Participants in the intervention group use digital remote monitoring tools, complete weekly symptom ratings, and wear a Fitbit for 90 days
Follow-up
Participants complete end of study questionnaires and interviews to provide feedback on the study
What Are the Treatments Tested in This Trial?
Interventions
- Digital remote monitoring intervention
Trial Overview
The study tests a digital remote monitoring tool that tracks patient symptoms in real-time during immunotherapy. It checks if the tool is easy to use, helps manage symptoms better, improves life quality, and increases engagement with healthcare providers.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will complete baseline, midpoint, and end of study measures and complete the Short Physical Performance Battery (SPPB) as feasible. Participants will rate symptoms weekly for 90 days using PRO-CTCAE questions to assess symptoms commonly associated with immune-related adverse events (irAEs). Participants will also wear a Fitbit activity tracker (Inspire 3 or similar) for the duration of the study and install the Fitbit app on their smartphone. The Fitbit is a wristwatch-sized waterproof device that assesses heart and breathing rates, physical activity, and sleep, skin temperature, and oxygen levels and wirelessly transmits data to the server. Data from the wearable devices along with electronic patient-reported outcomes will be used to detect and triage immune-related adverse events.
This group will complete baseline, midpoint, and end of study measures and complete the Short Physical Performance Battery (SPPB) as feasible but will not wear an activity tracker or rate weekly symptoms.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
Citations
Wearable sensor data visualization for patient monitoring and ...
This study focused on using Fitbit devices and a newly developed app, the Cancer Wellness Program (CWP), to help healthcare providers track ...
Effectiveness of symptom monitoring on electronic patient ...
The meta-analysis showed significant improvement in health-related quality of life (SMD = 2.44, P < 0.001) among patients with lung cancer.
The association between wearable device metrics and ...
We conducted a systematic review with best evidence synthesis to examine the association between WD metrics and clinical outcomes in patients with cancer.
Remote Patient Monitoring Using Mobile Health ...
This study aimed to gain insight into patients' perspectives and preferences for participating in mHealth-based monitoring in cancer care.
“Tracking Health: How Wearable Technology Is ...
Several studies have reported that WD can facilitate the routine monitoring of vital signs of cancer patients, including heart rate, respiratory ...
Application of wearables for remote monitoring of oncology ...
This review aims to systematically map and categorize the current state of wearable applications among oncology patients and to identify determinants impeding ...
Wearable activity monitors to assess performance status ...
Our trial demonstrates the feasibility of using wearable activity monitors to assess PS in advanced cancer patients and suggests their potential use to predict ...
Patient Experiences of Using Wearable Health Monitors ...
Wearable health monitors continuously measure physiological parameters and activity. Devices promote positive behaviour change in patients undergoing cancer ...
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