About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

under 18 years old; and

unable to read and write in English

Trial design

Design model

Parallel

Treatments tested in this trial

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 intervention
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Digital remote monitoring group (intervention)Experimental treatment 1 intervention

Group B: Usual careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame

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

2

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.

Time frame

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

3

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)

Time frame

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

4

Feasibility via engagement with surveys

engagement (how many weeks participants completed symptom surveys)

Time frame

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

Secondary outcomes

1

Patient-Reported Physical Symptoms

Symptoms will be assessed using the PRO version of the Common Terminology for Adverse Events (PRO-CTCAE; Dueck et al., 2015). PRO-CTCAE questions will assess 22 symptoms commonly associated with immune-related adverse events (irAEs), such as fatigue, diarrhea, abdominal pain, constipation, rash, and itchy skin. For each symptom, participants will be asked about the severity, frequency, and/or the extent to which a symptom interfered with their activities. Participants will be asked to complete one rating per week and will report on symptoms over the past 7 days. Responses range from 0-4, with higher scores indicating more severe symptoms.

Time frame