Feasibility of an Enhanced Symptom Monitoring and Expedited Subspecialty Care Referral Interventi… (NCT07660666) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Feasibility of an Enhanced Symptom Monitoring and Expedited Subspecialty Care Referral Intervention to Improve Side Effect Management for Patients With Melanoma Receiving an Immune Checkpoint Inhibitor
United States50 participantsStarted 2026-11-01
Plain-language summary
This clinical trial tests the feasibility of patient reported outcomes monitoring with early, rapid immunotherapy toxicity subspecialty care to improve side effect management for patients with melanoma receiving an immune checkpoint inhibitor. Immune checkpoint inhibitors have improved outcomes for patients with advanced melanoma, but their use is frequently complicated by immune related adverse events (irAEs). IrAEs can affect any organ system, range in severity from mild to life threatening, and often require a pause or stopping of immunotherapy treatment. Early identification and management of irAEs may reduce progression to severe toxicity. Electronic patient self reporting of symptoms with ways to support early involvement of non oncology subspecialists may be a feasible way to improve side effect management for patients with melanoma receiving an immune checkpoint inhibitor.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* PATIENT: Age 18 years or older
* PATIENT: Histologically confirmed diagnosis of melanoma
* PATIENT: Plan to begin a standard of care (SOC) immune checkpoint inhibitor (ICI) for the treatment of melanoma per Food and Drug Administration (FDA) approval and/or National Comprehensive Cancer Network (NCCN) guidelines
* PATIENT: Willing and able to provide informed consent
* CAREGIVER: Age 18 years or older
* CAREGIVER: Family member or primary caregiver of a study participant
Exclusion Criteria:
* PATIENT: Previously received ICI therapy
* PATIENT: Life expectancy of \< 6 months at time of enrollment
* PATIENT: Concurrently receiving a non-ICI systemic therapy
* PATIENT: Concurrently receiving radiation, unless hypofractionated palliative radiation prescribed to alleviate poorly controlled symptoms (e.g., pain)
* PATIENT: Needs to rely on a proxy to complete patient-reported outcome instruments
* PATIENT: Unwilling or unable to complete surveys electronically
* CAREGIVER: Needs to rely on a proxy to complete survey instrument(s)
* CAREGIVER: Unwilling or unable to complete surveys electronically
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of eligible patients who consent to the study and begin the intervention (feasibility of study enrollment)
Timeframe: At enrollment
2
Proportion of patients evaluated by subspecialists in ≤ 14 days among participants who enrolled and developed a suspected immune related adverse events (irAE) (grade 2 or higher) (feasibility of intervention delivery)