Observational Study of Sex Differences in Symptoms During Immune Checkpoint Inhibitor Treatment for People With Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute
About this trial
This study aims to learn more about symptoms that patients experience while receiving immunotherapy for cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.)
Disqualifiers
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.)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-Interventional Study
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Observational1 intervention
Trial outcomes
Primary outcomes
1
Patient-reported symptoms
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.
Time frame
Baseline, weekly thereafter up to 26 weeks2
Patient-reported Quality of Life (QOL) - Part 1
Will use the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)
Time frame
Baseline, month 3, month 63
Patient-reported QOL - Part 2
PROMIS Cognitive Function instruments
Time frame
Baseline, month 3, month 64
Patient-reported QOL - Part 3
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.
Time frame
Baseline, month 3, month 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
OHSU Knight Cancer Institute
Lead sponsor
Oregon Health and Science University
Collaborator
Source ClinicalTrials.gov