Recruiting

Remote Monitoring

Sponsor:

University of Pittsburgh

Code:

NCT07280715

Conditions

Cancer

Melanoma (Skin Cancer)

Immunotherapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digital remote monitoring intervention

Usual Care

Study Details

Brief 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.

Conditions

Cancer

Melanoma (Skin Cancer)

Immunotherapy

Study ID

NCT07280715

Start date

Jun 17, 2026

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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) as feasible 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.

Interventions

Digital 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.

Usual 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.

Primary outcome measure

  • Acceptability via semi-structured interviews [ Time Frame: At the end of the intervention (at approximately 90 days) ]
  • Acceptability via System Usability Scale [ Time Frame: At the end of the intervention (at approximately 90 days) ]
  • Feasibility via accrual rate [ Time Frame: From enrollment to the end of the intervention (at approximately 90 days) ]
  • Feasibility via engagement with surveys [ Time Frame: From enrollment to the end of the intervention (at approximately 90 days) ]
  • Feasibility via engagement with Fitbit [ Time Frame: From enrollment to the end of the intervention (at approximately 90 days) ]
  • Feasibility via completion rate [ Time Frame: From enrollment to the end of the intervention (at approximately 90 days) ]

Central Contacts and Locations

Central contacts

Carissa A Low

412-623-5973lowca@upmc.edu

Krina C Durica

duricak@upmc.edu

Locations

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Carissa A Low

412-623-5973lowca@upmc.edu

Principal Investigator:

Carissa A Low

More Information

Sponsor

University of Pittsburgh

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Keywords

  • quality of life
  • adverse events

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-21. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-08-04.