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RECRUITING

NCT06418204

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

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2025-01-30

Completion Date

2028-08-01

Last Updated

2026-11-02

Healthy Volunteers

Conditions

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

Interventions

OTHER

Non-interventional Study

Non-interventional study

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 planning to receive Immune Checkpoint Inhibitor (ICIs) targeting 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.

Locations (486)

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Kingman Regional Medical Center

Kingman, Arizona, United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

PCR Oncology

Arroyo Grande, California, United States

Mercy Cancer Center - Carmichael

Carmichael, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

Kaiser Permanente Dublin

Dublin, California, United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Kaiser Permanente Fresno Orchard Plaza

Fresno, California, United States

Kaiser Permanente-Fresno

Fresno, California, United States

Saint Agnes Medical Center

Fresno, California, United States

Saint Helena Hospital

Fresno, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Kaiser Permanente- Modesto MOB II

Modesto, California, United States

Kaiser Permanente-Modesto

Modesto, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Kaiser Permanente- Marshall Medical Offices

Redwood City, California, United States

Kaiser Permanente-Richmond

Richmond, California, United States

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

Kaiser Permanente Downtown Commons

Sacramento, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Kaiser San Rafael-Gallinas

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Providence Medical Foundation - Santa Rosa

Santa Rosa, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Saint Helena Hospital

St. Helena, California, United States

Saint Joseph's Medical Center

Stockton, California, United States

Kaiser Permanente-Stockton

Stockton, California, United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Woodland Memorial Hospital

Woodland, California, United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

Kaiser Permanente-Franklin

Denver, Colorado, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, United States

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, United States

Kaiser Permanente-Rock Creek

Lafayette, Colorado, United States

CommonSpirit Saint Anthony Hospital Cancer Center

Lakewood, Colorado, United States

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Kaiser Permanente-Lone Tree

Lone Tree, Colorado, United States

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, United States

Saint Anthony North Hospital

Westminster, Colorado, United States

Beebe South Coastal Health Campus

Millville, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Morton Plant Hospital

Clearwater, Florida, United States

South Florida Baptist Hospital

Plant City, Florida, United States

Saint Anthony's Hospital Cancer Care Center

St. Petersburg, Florida, United States

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, United States

Winter Haven Hospital

Winter Haven, Florida, United States

Northside Hospital

Atlanta, Georgia, United States

John B Amos Cancer Center

Columbus, Georgia, United States

Northside Hospital - Duluth

Duluth, Georgia, United States

Liberty County Cancer Care

Hinesville, Georgia, United States

Regional Cancer Care - Jesup

Jesup, Georgia, United States

Northside Hospital - Gwinnett

Lawrenceville, Georgia, United States

Atrium Health Navicent

Macon, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza