Investigating Real-Time Immunotherapy Symptoms Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh

About 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.

Eligibility criteria

Qualifiers

within three months of starting immune checkpoint inhibitor therapy at UPMC Hillman Cancer Center for advanced melanoma;

age 18 years or older;

ability to read and write in English;

owns and uses a smartphone capable of running study applications

Disqualifiers

under 18 years old; and

unable to read and write in English

Trial design

Treatments tested in this trial

  • Digital remote monitoring intervention
  • Usual Care

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

1
UPMC Hillman Cancer Center15232, PittsburghPennsylvania, United States

Sponsors and collaborators

University of Pittsburgh

Lead sponsor