INvestigating Sex and Gender-Related Differences in Immunotherapy Treatment Effects (INSITE)
Summary
This study aims to learn more about symptoms that patients experience while receiving immunotherapy for cancer.
Detailed description
PRIMARY OBJECTIVES: I. Characterize sex differences in patient-reported symptomatic immune-related adverse events. II. Determine the level of discordance between clinician-assessed and patient-reported symptomatic immune-related adverse events according to patient gender. OUTLINE: This is an observational study. Patients complete surveys and have their medical records reviewed on study.
Arms & interventions
- OtherNon-Interventional Study
Non-Interventional Study
Outcome measures
Primary
Patient-reported symptoms
Will compare the number, severity, and burden of symptoms by sex. Will be assessed using the Common Toxicity Criteria and Adverse Events v1.0 (PRO-CTCAE) reporting tool.
Time frame: Baseline, weekly thereafter up to 26 weeks
Patient-reported QOL - Part 1
Will use the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)
Time frame: Baseline, month 3, month 6
Patient-reported QOL - Part 2
PROMIS Cognitive Function instruments
Time frame: Baseline, month 3, month 6
Patient-reported QOL - Part 3
Selected questions from the EORTC-QLQ-C30 to evaluate the impact of immunotherapy on QOL.
Time frame: Baseline, month 3, month 6
Clinician-assessed patient symptoms
Clinicians will rate patient symptoms according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scoring system, which grades adverse events according to 5 categories of severity and requires evaluation of the extent to which the adverse event can be attributed to treatment ("unrelated" to "definite"). Will examine agreement using intraclass correlations by patient gender.
Time frame: Baseline, month 3, month 6
Eligibility criteria
Study locations (1)
OHSU Knight Cancer Institute
Portland, Oregon, 97239