Digital Remote Patient Monitoring and Triage During Cancer Immunotherapy
University of Pittsburgh
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 for 90 days. * At the end of the study, complete a semi-structured interview to provide feedback on the study.
Description
Participants (n = 40) will be recruited from UPMC Hillman clinics. If eligible patients consent to participate, they will complete online baseline, midpoint, and end of study questionnaires. Participant's medical records will be reviewed to extract demographic information and clinical covariates, including information about their cancer, its treatment, biological variables such as sex and age, clinical variables such as comorbidities, surgeries and hospitalizations, medications, and other markers of health care utilization (e.g., emergency department visits). Once extracted, these values will…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * under 18 years old; and * unable to read and write in English
Interventions
- BehavioralDigital remote monitoring intervention
Responses to the PRO-CTCAE questions range from 0-4. Any grade 2-4 response (reflecting moderate to severe symptoms) will trigger a recommendation that the participant may want to contact their provider about the potentially concerning symptom. Fitbit data points exceeding prespecified thresholds based on physiological norms (for skin temperature and pulse oxygenation) or each participants' historic average (heart rate and activity) will also trigger a recommendation that the participant may want to contact their provider about the potentially concerning data point. Participants will receive weekly data reports that show summaries/graphs of recent alerts triggered, symptom ratings, and Fitbit data.
- OtherUsual Care
Participants will complete baseline, midpoint, and end of study measures and complete the Short Physical Performance Battery (SPPB). They will not complete surveys, wear a Fitbit, or receive recommendations about when they might want to reach out to a provider about potentially concerning symptoms or Fitbit values. Participants will use the standard information they receive from clinic about how to manage their symptoms and when to contact their care team.
Location
- UPMC Hillman Cancer CenterPittsburgh, Pennsylvania