A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoint Inhibitor Immunotherapy

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Polymyalgia Rheumatica; Immune Checkpoint Inhibitors; Arthritis

Study type: Observational

Funder types: Other

Identifiers

NCT06647134

NCI-2024-07031 (Other Identifier)

2024-0342

Details and patient eligibility

About

To understand the severity and nature of participants experiences during irAEs following immune checkpoint inhibitor immunotherapy.

Full description

1. To understand the severity and nature of participants experiences during rheumatic immune-related adverse events following immune checkpoint inhibitor immunotherapy, including their functional impact
2. To explore domains relevant to participants experiencing rheumatic immune-related adverse events following immune checkpoint inhibitor immunotherapy, and attitudes to domains identified from the literature

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

The criteria are:

• Patients aged 18 years and above
• English (conversational level) speaking, with the ability to give informed consent
• Patients with a rheumatologist clinician diagnosis of inflammatory arthritis irAE or PMR irAE following ICI therapy

Exclusion Criteria

• Acutely life-threatening or worsening cancer
• Hearing impairment functionally limiting participation in verbal interview