Investigating Real-Time Immunotherapy Symptoms Study

NCT ID: NCT07280715

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-19
• Study Completion Date: 2026-09-01

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.

Detailed 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 be linked only to their study ID number.

As feasible, participants will complete the Short Physical Performance Battery (SPPB) at the UPMC Hillman Cancer Center or the research team's office at baseline and at the end of the study. During these visits, this in-person assessment will be administered by trained study team members. Participants that enroll in the study remotely will be invited to complete the in-person SPPB as feasible. The SPPB will be conducted within 2 weeks of the enrollment date and within 2 weeks of the end of study date.

Following informed consent and completing baseline questionnaires, participants will then be randomized into the digital remote monitoring group or usual care (1:1).

For participants in the intervention condition (digital remote monitoring group):

At the initial study visit, participants in the digital remote monitoring group will be oriented to the ecological momentary assessment procedures to assess patient reported symptoms.

Participants in the digital remote monitoring group will receive a weekly text message containing a secure link to a brief (approximately 5 minute) online symptom survey administered via Qualtrics. Each participant is assigned a unique, non-identifying study ID, which is embedded in their survey link to ensure responses are associated with the correct participant. A secure Qualtrics-based contact log, accessible only to authorized study personnel, will maintain phone numbers and study IDs for survey distribution. No survey data is stored on the participant's device, and no personally identifiable information is collected within the survey. All data is linked only to the study ID. Data usage requirements are not significantly different from what most smartphone users would require if they use their device to access the Internet for web searching.

Symptoms will be assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The PRO-CTCAE includes 22 symptoms commonly associated with immune-related adverse events (irAEs), such as fatigue, diarrhea, abdominal pain, constipation, rash, itchy skin, dry skin, muscle aches, joint pain, arm or leg swelling, decreased appetite, nausea, vomiting, shortness of breath, cough, headache, dry mouth, blurry vision, dizziness, pain or burning with urination, eye irritation (e.g., itching, watering, stinging, foreign body sensation), and nasal congestion. Participants are asked to report on symptoms experienced over the past 7 days. Responses are rated on a 0-4 scale.

If a participant reports a rating of 2 (moderate), 3 (severe), or 4 (very severe) for any symptom, an automated alert will appear at the end of the survey. This alert will inform participants that their responses may be concerning and that they should consider contacting their clinical care team. The alert will also include a summary of the self-reported severity, frequency, and/or interference for the relevant symptom(s), along with links to symptom management resources on the National Cancer Institute website.

In addition to the PRO-CTCAE questions in the weekly survey, participants in the digital remote monitoring group will also be asked to rate their overall quality of life for that day from 0 (worst possible) to 10 (best possible), report any cancer treatment they've received since the last survey, and indicate if they have communicated with their cancer care team since their last survey.

Participants in the digital remote monitoring group will receive weekly email reports from the study team that show summaries/graphs of recent alerts triggered, symptom ratings, and Fitbit data. Participants may choose to share these data reports with their care team, family members, etc.

Participants in the remote monitoring group will also be asked to wear a Fitbit device as feasible (Fitbit Inspire 3 or similar) for the duration of the study and to 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. Participants will be asked to charge the device as needed, approximately every 4-5 days. If participants already own a Fitbit device that collects comparable data to the study provided device, the study team will request access to the participant's Fitbit data for the duration of their study participation. 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 trigger a recommendation that the participant may want to contact their provider about the potentially concerning data point(s).

At the end of the study, participants will complete an end of study interview.

Conditions

Cancer; Melanoma (Skin Cancer); Immunotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Digital remote monitoring intervention

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• within one week 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Carissa Low

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carissa A Low

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Central Contacts

Carissa A Low

Role: CONTACT

lowca@upmc.edu

412-623-5973

Krina C Durica

Role: CONTACT

duricak@upmc.edu

Facility Contacts

Carissa A Low

Role: primary

lowca@upmc.edu

412-623-5973

Other Identifiers

STUDY25090094

Identifier Type: -

Identifier Source: org_study_id