INvestigating Sex and Gender-Related Differences in Immunotherapy Treatment Effects (INSITE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Patient-reported QOL - Part 1
研究概览
简要总结
This study aims to learn more about symptoms that patients experience while receiving immunotherapy for cancer.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.)
排除标准
- •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.)
- •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.)
- •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.)
- •Needs to rely on a proxy to complete patient-reported outcome instruments (Confirmed by self-report on Health History Questionnaire.)
- •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.
研究组 & 干预措施
Observational
Patients complete surveys and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Patient-reported QOL - Part 1
时间窗: Baseline, month 3, month 6
Will use the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)
Patient-reported QOL - Part 2
时间窗: Baseline, month 3, month 6
PROMIS Cognitive Function instruments
Patient-reported symptoms
时间窗: 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 QOL - Part 3
时间窗: 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
时间窗: 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.
Patient-reported Quality of Life (QOL) - Part 1
时间窗: Baseline, month 3, month 6
Will use the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)
次要结局
未报告次要终点
研究者
Deanne Tibbitts
Principal Investigator
OHSU Knight Cancer Institute