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Trial Title:
Observational Study of Sex Differences in Symptoms During Immune Checkpoint Inhibitor Treatment for People With Cancer
NCT ID:
NCT06562777
Condition:
Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Non-Interventional Study
Description:
Non-Interventional Study
Arm group label:
Observational
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
OHSU Knight Cancer Institute
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Deanne Tibbitts
Phone:
503-494-4361
Email:
tibbitts@ohsu.edu
Investigator:
Last name:
Deanne Tibbitts
Email:
Principal Investigator
Start date:
September 15, 2023
Completion date:
July 31, 2025
Lead sponsor:
Agency:
OHSU Knight Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Oregon Health and Science University
Agency class:
Other
Source:
OHSU Knight Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06562777
