Digital Remote Monitoring for Cancer Immunotherapy

(IRIS Trial)

Overseen By Krina C Durica

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to evaluate the feasibility of using information from wearable devices and self-reported symptoms to remotely monitor patients during immunotherapy. The main questions it aims to answer are:

* Is the digital remote patient monitoring tool feasible and acceptable to patients?

* Do the alerts and guidance improve symptom management, quality of life, and engagement with the care team during treatment?

Participants will:

* Complete a demographic questionnaire at the beginning of the study and quality-of-life and health questionnaires at the beginning, midpoint, and end of study.

* As feasible: At the beginning and end of the study, complete an in-person physical function assessment measuring balance (Short Physical Performance Battery).

If participant is randomly assigned to the intervention group, they will also:

* Complete weekly symptom ratings via digital remote patient monitoring tool

* Wear a Fitbit activity tracker for 90 days.

* At the end of the study, complete a semi-structured interview to provide feedback on the study.

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

Ability to read and write in English

Owns and uses a smartphone capable of running study applications

I am starting immune therapy for advanced melanoma at UPMC within a week.

Exclusion Criteria

Unable to read and write in English

I am younger than 18.

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?

Group I: Digital remote monitoring group (intervention) Experimental Treatment 1 Intervention

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.

Group II: Usual care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+