Observational Study of Sex Differences in Symptoms During Immune Checkpoint Inhibitor Treatment for People With Cancer

INvestigating Sex and Gender-Related Differences in Immunotherapy Treatment Effects (INSITE)

This study aims to learn more about symptoms that patients experience while receiving immunotherapy for cancer.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Non-Interventional Study

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • OHSU Knight Cancer Institute
      • Contact: Deanne Tibbitts; Phone Number: 503-494-4361; Email: tibbitts@ohsu.edu
      • Principal Investigator: Deanne Tibbitts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who will begin standard-of-care (SOC) immunotherapy for the treatment of cancer at OHSU and Knight Cancer Institute Community Hematology Oncology (CHO) clinics.

Description

Inclusion Criteria:

1. Age 18 years or older on date of enrollment (Confirmed by review of the date of birth as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
2. Histologically confirmed diagnosis of cancer and plan to begin SOC immunotherapy for the treatment of cancer per FDA approval and/or National Comprehensive Cancer Network (NCCN) guidelines (Confirmed by review of cancer diagnosis and treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
3. Treating oncologist anticipates at least 6 consecutive months of SOC immunotherapy (Confirmed by review of the treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)

Exclusion Criteria:

1. Diagnosed with breast, prostate, testicular, penile, or gynecologic cancer (Confirmed by review of the cancer diagnosis as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
2. Previously received immunotherapy (Confirmed by review of cancer treatment history as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
3. Life expectancy of <6 months at time of enrollment per the treating oncologist (Confirmed by the professional opinion of the treating oncologist and subsequently recorded in a CRF.)
4. Concurrently receiving a non-immunotherapy treatment, including chemotherapy, biological, or targeted therapy (Confirmed by review of the treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
5. Concurrently receiving radiation, unless hypofractionated palliative radiation prescribed to alleviate poorly controlled symptoms (e.g. pain) (Confirmed by review of the treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
6. Participation in a clinical trial of experimental immunotherapy (Confirmed by review of the treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
7. Needs to rely on a proxy to complete patient-reported outcome instruments (Confirmed by self-report on Health History Questionnaire.)
8. Unwilling or unable to complete consent form and surveys electronically (Confirmed by successful completion of electronic consent form and baseline survey in REDCap.)

Assessment of participant eligibility is at the discretion of the Principal Investigator, Dr. Deanne Tibbitts.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; Patients complete surveys and have their medical records reviewed on study.	Other: Non-Interventional Study; Non-Interventional Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, weekly thereafter up to 26 weeks
Patient-reported QOL - Part 1	Will use the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)	Baseline, month 3, month 6
Patient-reported QOL - Part 2	PROMIS Cognitive Function instruments	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.	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.	Baseline, month 3, month 6

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: Deanne Tibbitts, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 16, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Estimated): October 31, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: STUDY00025328 (Other Identifier: OHSU Knight Cancer Institute); NCI-2023-06611 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No