Protocol No.A172401
WF2304-A172401
Principal InvestigatorDittus, Kim
PhaseN/A
Age GroupAdult
ClinicalTrials.GovNCT06418204 (Click to jump to clinicaltrials.gov)
Management Group(s) Palliative Care

Title
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

Description
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.

Objective
Primary:
-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.

Treatment 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.

Key Eligibility 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.

Applicable Disease Sites
Breast; Colon and Rectum; Lung; Lymphoma; Melanoma/Skin cancer

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital