Clinical trial NCT06562777: Observational Study of Sex Differences in Symptoms During Immune Checkpoint Inhibitor Treatment for People With Cancer
Official title: INvestigating Sex and Gender-Related Differences in Immunotherapy Treatment Effects (INSITE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2024-08-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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-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.

Eligibility 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.

Primary outcomes:
measure: Patient-reported symptoms
timeFrame: Baseline, weekly thereafter up to 26 weeks
measure: Patient-reported QOL - Part 1
timeFrame: Baseline, month 3, month 6
measure: Patient-reported QOL - Part 2
timeFrame: Baseline, month 3, month 6
measure: Patient-reported QOL - Part 3
timeFrame: Baseline, month 3, month 6
measure: Clinician-assessed patient symptoms
timeFrame: Baseline, month 3, month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Deanne Tibbitts
role: PRINCIPAL_INVESTIGATOR
References: