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

Official 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

Overview

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.

Detailed description

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.

Interventions

• Other Non-interventional Study
  Non-interventional study

Primary outcome measures

• Cancer-related symptoms [Time frame: Baseline and re-assessed monthly up to 12 months post-enrollment]

Secondary outcome measures (4)

• Cannabis and Cannabinoid Use from Cannabis Engagement Assessment [Time frame: Baseline and re-assessed monthly up to 12 months post-enrollment]
• Cannabis and Cannabinoid Use from the International Cannabis Policy Study survey [Time frame: Baseline and re-assessed monthly up to 12 months post-enrollment]
• Cannabis and Cannabinoid Perceived Benefits and Harms [Time frame: Baseline and re-assessed monthly up to 12 months post-enrollment]
• Cannabis and Cannabinoid Adverse Effects [Time frame: Baseline and re-assessed monthly up to 12 months post-enrollment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 464 centers

• Fairbanks Memorial Hospital — Fairbanks
• Kingman Regional Medical Center — Kingman
• Cancer Center at Saint Joseph's — Phoenix
• Mercy Hospital Fort Smith — Fort Smith
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro
• Kaiser Permanente-Deer Valley Medical Center — Antioch
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande
• PCR Oncology — Arroyo Grande
• … and 456 more centers

Puerto Rico · 3 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06418204 · IRB00122898 · NCI-2024-03314 · WF2304-A172401 · 5UG1CA189824 · 1U01CA286813

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗