Clinical Trial

Investigating Real-Time Immunotherapy Symptoms Study

Study acronym: IRIS
Recruiting
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Summary
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 as feasible for 90 days. * At the end of the study, complete a semi-structured interview to provide feedback on the study.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-07-08
notable Primary completion pushed: 2026-08-01 -> 2026-12-31 2026-05-12
minor Completion pushed: 2026-09-01 -> 2026-12-31 2026-05-12
Trial Details
NCT Number NCT07280715
Lead Sponsor University of Pittsburgh
Conditions Cancer, Melanoma (Skin Cancer), Immunotherapy
Enrollment 40 participants
Start Date 2026-06-17
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-04