Investigating Real-Time Immunotherapy Symptoms Study
Recruiting · NCT07280715 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Pittsburgh
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- receiving immune checkpoint inhibitor therapy at UPMC Hillman Cancer Center for melanoma;
- age 18 years or older;
- ability to read and write in English;
- owns and uses a smartphone capable of running study applications
Exclusion criteria
- under 18 years old; and
- unable to read and write in English
Where it is running
1 location listed across 1 US state.
- UPMC Hillman Cancer Center - Pittsburgh, Pennsylvania, United States