Status:
RECRUITING
Observational Study of Sex Differences in Symptoms During Immune Checkpoint Inhibitor Treatment for People With Cancer
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
Oregon Health and Science University
Conditions:
Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Brief 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-repor...
Eligibility Criteria
Inclusion
- 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.)
- 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.)
- 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
- 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.)
- Previously received immunotherapy (Confirmed by review of cancer treatment history as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
- 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.)
- 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.)
- 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.)
- 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.)
- Needs to rely on a proxy to complete patient-reported outcome instruments (Confirmed by self-report on Health History Questionnaire.)
- 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.
Key Trial Info
Start Date :
September 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06562777
Start Date
September 15 2023
End Date
March 1 2026
Last Update
October 31 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239