Investigating Real-Time Immunotherapy Symptoms Study

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT07280715
Status
Not Yet Recruiting

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Conditions

  • Cancer
  • Immunotherapy
  • Melanoma (Skin Cancer)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Digital remote monitoring intervention — BEHAVIORAL
    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.
  • Usual Care — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Digital remote monitoring group (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.
  • Active Comparator: Usual care
    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.

Primary Outcome Measure

Acceptability via semi-structured interviews [ Time Frame: At the end of the intervention (at approximately 90 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Carissa A Low
[email protected]
412-623-5973
Carissa A Low (PRINCIPAL_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By research site
UPMC Hillman Cancer Center· Pittsburgh, PA

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