Investigating Real-Time Immunotherapy Symptoms Study for Melanoma
This study is looking at how well a digital remote monitoring system works for people with melanoma (skin cancer) who are starting immunotherapy. Immunotherapy is a type of cancer treatment that helps your body's immune system fight cancer. The study wants to see if using a smartphone app to track your symptoms and get recommendations helps you manage side effects, improves your quality of life, and helps you stay connected with your care team. You would either use this digital monitoring system or receive usual care. The study aims to enroll 40 participants and is currently unclear on its recruitment status. Success will be measured by how acceptable and practical the digital tool is for patients.
- Study design
- This is an interventional study with 40 participants. You would be randomly assigned to either the digital remote monitoring group or the usual care group.
- What's involved
- You would complete questionnaires at the beginning, middle, and end of the study, and possibly an in-person physical function assessment at the beginning and end. The intervention period is approximately 90 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at the end of the intervention, which is approximately 90 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Investigating Real-Time Immunotherapy Symptoms Study
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Carissa A Low · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Acceptability via semi-structured interviewsAt 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 ScaleAt 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 the system being studied.
- Feasibility via accrual rateFrom 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 surveysFrom enrollment to the end of the intervention (at approximately 90 days)
engagement (how many weeks participants completed symptom surveys)
- Feasibility via engagement with FitbitFrom 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 rateFrom enrollment to the end of the intervention (at approximately 90 days)
completion rate (number of participants that complete the study)