Investigating Real-Time Immunotherapy Symptoms Study

NCT07280715 | Not Yet Recruiting

• 1 other identifier: STUDY25090094
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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

Keywords

quality of life; adverse events

Outcome Measures

Primary Outcomes (6)

• Acceptability via semi-structured interviews

  Post-intervention semi-structured interviews will be conducted to gather participant feedback and assess acceptability of the intervention. Participants will be asked to rate the likelihood they would keep using system on their own and to recommend system on a scale from 0 (not at all likely) to 10 (extremely likely). Responses will be averaged.

  At the end of the intervention (at approximately 90 days)

• Acceptability via System Usability Scale

  System Usability Scale (SUS). For odd items, subtract one from the user response. For even-numbered items, subtract the user responses from 5. This scales all values from 0 to 4 (with four being the most positive response). Add up the converted responses for each user and multiply that total by 2.5. Possible range of scores is 0 to 100 representing a composite measure of the overall usability of the system being studied.

  At the end of the intervention (at approximately 90 days)

• Feasibility via accrual rate

  accrual rate (number of participants that enroll \[consent and provide at least one form of data\] out of number of participants approached)

  From enrollment to the end of the intervention (at approximately 90 days)

• Feasibility via engagement with surveys

  engagement (how many weeks participants completed symptom surveys)

  From enrollment to the end of the intervention (at approximately 90 days)

• Feasibility via engagement with Fitbit

  engagement (how many days within the study the participants had Fitbit data)

  From enrollment to the end of the intervention (at approximately 90 days)

• Feasibility via completion rate

  completion rate (number of participants that complete the study)

  From enrollment to the end of the intervention (at approximately 90 days)

Secondary Outcomes (1)

• Patient-Reported Physical Symptoms

  Change from baseline to the end of the intervention (at approximately 90 days)

Other Outcomes (5)

• Objective physical activity

  Change from baseline to the end of the intervention (at approximately 90 days)

• Self-Efficacy for Managing Symptoms

  Change from baseline to the end of the intervention (at approximately 90 days)

• Short Physical Performance Battery (SPPB)

  Change from baseline to the end of the intervention (at approximately 90 days)

Study Arms (2)

Digital remote monitoring group (intervention)

EXPERIMENTAL

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.

Behavioral: Digital remote monitoring intervention

Usual care

ACTIVE COMPARATOR

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.

Other: Usual Care

Interventions

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.

Usual care

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.

Digital remote monitoring group (intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• under 18 years old; and
• unable to read and write in English

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Carissa A Low

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carissa A Low

CONTACT

412-623-5973; lowca@upmc.edu

Krina C Durica

CONTACT

duricak@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized to the digital remote monitoring group or usual care

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)