Observational Study on Sex Differences in Immunotherapy Symptoms
This observational study aims to understand how symptoms differ between sexes when people with cancer receive immunotherapy. Researchers will look at symptoms you report, as well as your quality of life (how well you are doing and feeling), at the start of treatment and regularly for up to six months. The study will also compare your reported symptoms with what your doctors observe. You may be able to join if you are 18 or older, have a confirmed cancer diagnosis, and are planning to start standard immunotherapy treatment. The study plans to enroll 100 participants, but its current recruitment status is unclear.
- Study design
- This is an observational study, meaning participants will not receive an experimental treatment. It plans to enroll 100 participants.
- What's involved
- You will complete surveys and have your medical records reviewed. These assessments will occur at the start of the study, weekly for symptoms, and at 3 and 6 months for quality of life.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your symptoms will be tracked weekly for up to 26 weeks, and your quality of life will be assessed at 3 and 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Observational Study of Sex Differences in Symptoms During Immune Checkpoint Inhibitor Treatment for People With Cancer
At a glance
Conditions
NCT06562777
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
OHSU Knight Cancer Institute
Portland, Oregonstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Deanne Tibbitts · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Patient-reported symptomsBaseline, 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 1Baseline, month 3, month 6
Will use the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)
- Patient-reported QOL - Part 2Baseline, month 3, month 6
PROMIS Cognitive Function instruments
- Patient-reported QOL - Part 3Baseline, 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 symptomsBaseline, 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.