University of Kansas Medical Center

Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics

Purpose

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.

Conditions

Breast Carcinoma
Colorectal Carcinoma
Lung Non-Small Cell Carcinoma
Melanoma
Non-Hodgkin Lymphoma

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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.

Exclusion Criteria

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.

Study Design

Phase
Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective