Symptom Tracking and Faster Specialist Care for Melanoma Patients on Immunotherapy

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with melanoma who are about to start a standard immune checkpoint inhibitor. Family members or main caregivers can also join.

Age

18 years or older (patients and caregivers)

Sex

All sexes

Disease stage

Melanoma confirmed by tissue examination

Earlier treatment

Patients plan to start a standard immune checkpoint inhibitor (ICI) for melanoma. They must not have had ICI therapy before.

Main reasons for not taking part

• Has already had ICI therapy
• Life expectancy under 6 months
• Taking another non-ICI systemic therapy at the same time
• Needs someone else to complete the patient-reported surveys
• Unwilling or unable to complete surveys electronically

The registry criteria, word for word

What the trial wants to find out

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.

The group in the trial

• Supportive care (ePRO monitoring and referrals)Treatment being tested

  Patients complete an ePRO assessment, where they rate the frequency and/or severity of symptoms that may indicate a moderate to severe irAE, weekly for 6 months. If a patient rates a symptom at a frequency or severity level of moderate or higher, a care provider is notified and determines if the symptoms warrant evaluation by a non-oncology subspecialist or can be managed by medical oncology. Patients receive a referral to an appropriate subspecialist, complete an evaluation of the suspected irAE, within 14 days of the referral, and receive standard of care treatment.

  Treatment: Electronic Health Record Review, Internet-Based Intervention, Patient Navigation, and Survey Administration