Complementary Options for Symptom Management In Cancer (COSMIC): Assessing Benefits and Harms of Cannabis and Cannabinoid Use Among a Cohort of Cancer Patients Treated in Community Oncology Clinics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 891
- 主要终点
- Cancer-related symptoms
研究概览
简要总结
This is a multi-site clinical study enrolling 2000 newly diagnosed patients with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer, who are planning to receive one or more systemic cancer directed therapies with chemotherapy and/or (immune checkpoint inhibitors) ICIs.
详细描述
The objective of this study is to examine the association between cannabis and/or cannabinoid use and cancer-related symptoms assessed monthly for one year in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning or recently started to receive one or more systemic cancer directed therapies with chemotherapy and/or immune check point inhibitors (ICIs) targeting PD-1, PD-L1 or CTLA-4.
Participants 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
- •Adults aged 18 years or older with one of the following newly diagnosed cancers: breast cancer, colorectal cancer, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer (e.g. adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous cell carcinoma, and not otherwise specified).
- •Planned treatment with systemic chemotherapy (single or multi-agent, includes targeted therapy) and/or immune checkpoint inhibitor therapy (targeting PD-1, PD-L1 or CTLA-4). If unable to engage participant before treatment starts, enrollment is allowed up to the start of Cycle 2 treatment.
- •Participants must be able to comprehend English or Spanish (for survey completion).
- •Participants must have a working email address and be must be willing to complete surveys online. This can be completed at home, in the clinic or other location.
- •Completion of the confidential Self-Reported Screening Survey and receipt of a screening result - eligible for enrollment.
- •Participant must reside in the United States, officially determined per patient report on Self-reported Screening Survey
- •In the treating provider's opinion, the participant should have a life expectancy of >=6 months. Participants in hospice are not eligible.
- •Optional Sub-study (available at select sites only):
- •Must be willing to participate in both the main study and the sub-study at the Wake Forest University Comprehensive Cancer Center (WF CCC) and Virginia Commonwealth University (VCU).
- •Must be receiving treatment at the WF CCC and VCU.
- •Must be diagnosed with non-small cell lung cancer.
- •Must be planning to receive paclitaxel as part of their chemotherapy in conjunction with Immune Checkpoint Inhibitor (ICIs) PD-1, PD-L1 or CTLA-4.
排除标准
- •Currently enrolled in an interventional supportive treatment trial to manage cancer symptoms.
- •Participants with known pregnancy.
- •Participant received systemic therapy treatment for prior cancer(s) including chemotherapy, immunotherapy, targeted therapy, and hormonal therapy.
- •Participants enrolled in hospice.
- •Optional Substudy (available at select sites only):
- •Participants with chronic or ongoing steroid or immunomodulatory agents (i.e., prednisone, dexamethasone, etanercept, infliximab, etc.). The use of glucocorticoids as pre-medications for chemotherapy treatment is allowed.
- •Participants with a history of HIV, hepatitis B or hepatitis C.
研究组 & 干预措施
Observational
Participants 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
Cancer-related symptoms
时间窗: Baseline and re-assessed monthly up to 12 months post-enrollment
Will use the National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events to measure cancer-related symptoms. Will examine the longitudinal relationship between cannabis and/or cannabinoid use and the likelihood of exhibiting individual symptoms using three-level GLMMs to account for the nested data. The investigators will model continuous measures (e.g., symptom severity) using a linear generalized linear mixed-effects models (GLMM) and the prevalence of symptoms or moderate to severe symptoms using a logistic GLMM. Cannabis and/or cannabinoid use at each monthly assessment will be included as a time-varying covariate and an interaction with time will be included to assess its impact on symptoms over time. Analyses will consider dichotomous definitions of use (yes/no past month), frequency of use (# days in the past month) as well as mode of administration, dose/potency, and cannabinoid type.
次要结局
- Cannabis and Cannabinoid Use from Cannabis Engagement Assessment(Baseline and re-assessed monthly up to 12 months post-enrollment)
- Cannabis and Cannabinoid Use from the International Cannabis Policy Study survey(Baseline and re-assessed monthly up to 12 months post-enrollment)
- Cannabis and Cannabinoid Perceived Benefits and Harms(Baseline and re-assessed monthly up to 12 months post-enrollment)
- Cannabis and Cannabinoid Adverse Effects(Baseline and re-assessed monthly up to 12 months post-enrollment)