Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
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.
Interventions
OTHERNon-Interventional Study
Non-Interventional Study
Sponsors
OHSU Knight Cancer Institute
Oregon Health and Science University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported symptoms | Baseline, weekly thereafter up to 26 weeks | 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. |
| Patient-reported Quality of Life (QOL) - Part 1 | Baseline, month 3, month 6 | Will use the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) |
| Patient-reported QOL - Part 2 | Baseline, month 3, month 6 | PROMIS Cognitive Function instruments |
| Patient-reported QOL - Part 3 | Baseline, month 3, month 6 | 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. |
| Clinician-assessed patient symptoms | Baseline, month 3, month 6 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDeanne Tibbitts
OHSU Knight Cancer Institute
Outcome results
None listed