NCT07280715: IRIS

Digital Remote Patient Monitoring and Triage During Cancer Immunotherapy

Not yet recruiting NA Last updated 5 May 2026

What this trial tests

NA trial testing Digital remote monitoring intervention in Cancer in 40 participants. Not yet recruiting.

Timeline

1 June 2026

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	40
Start date	1 June 2026
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across United States

Drugs / interventions tested

• Digital remote monitoring intervention
• Usual Care

Conditions studied

• Cancer — all drugs for Cancer →
• Melanoma (Skin Cancer) — all drugs for Melanoma (Skin Cancer) →
• Immunotherapy — all drugs for Immunotherapy →

Sponsor

University of Pittsburgh

Who can join

18 and older, any sex, with Cancer or Melanoma (Skin Cancer). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Acceptability via semi-structured interviews
  Time frame: At the end of the intervention (at approximately 90 days)
  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.
• Acceptability via System Usability Scale
  Time frame: At the end of the intervention (at approximately 90 days)
  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 t
• Feasibility via accrual rate
  Time frame: From enrollment to the end of the intervention (at approximately 90 days)
  accrual rate (number of participants that enroll \[consent and provide at least one form of data\] out of number of participants approached)
• Feasibility via engagement with surveys
  Time frame: From enrollment to the end of the intervention (at approximately 90 days)
  engagement (how many weeks participants completed symptom surveys)
• Feasibility via engagement with Fitbit
  Time frame: From enrollment to the end of the intervention (at approximately 90 days)
  engagement (how many days within the study the participants had Fitbit data)
• Feasibility via completion rate
  Time frame: From enrollment to the end of the intervention (at approximately 90 days)
  completion rate (number of participants that complete the study)

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.