This study aims to learn more about symptoms that patients experience while receiving immunotherapy for cancer.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Non-Interventional Study
OHSU Knight Cancer Institute
Portland, Oregon, United States
RECRUITINGPatient-reported symptoms
Will compare the number, severity, and burden of symptoms by sex. Will be assessed using the Patient-Reported Outcomes Common Toxicity Criteria and Adverse Events (PRO-CTCAE) version (v)1.0 reporting tool.
Time frame: Baseline, weekly thereafter up to 26 weeks
Patient-reported Quality of Life (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 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 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 (National Cancer Institute 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
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