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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants complete surveys and have their medical records reviewed on study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at the benefits and harms of cannabis and cannabinoids in people with cancer. It will enroll 2,000 adults with certain newly diagnosed cancers who plan to get chemotherapy, targeted therapy, or certain immune treatments.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older with newly diagnosed breast cancer, colorectal cancer (colon or rectum), melanoma (skin cancer), non-Hodgkin lymphoma, or non-small cell lung cancer.
  • Plan to get chemotherapy, including targeted therapy, and/or immune checkpoint inhibitors (drugs that help the immune system fight cancer). You may join up to the start of your second treatment cycle.
  • Be able to understand English or Spanish.
  • Have a working email address and be willing to complete online surveys.
  • Complete the private screening survey and get a result saying you can join.
  • Live in the United States, as reported on the screening survey.
  • Your treating provider must expect you to live at least 6 months.
  • Optional smaller study: Be willing to join both studies, receive care at Wake Forest University Comprehensive Cancer Center or Virginia Commonwealth University, and plan to get an immune checkpoint inhibitor targeting PD-1, PD-L1, or CTLA-4.

Who can't join

  • You are in another trial testing a treatment to manage cancer symptoms.
  • You are known to be pregnant.
  • You received chemotherapy, immune therapy, targeted therapy, or hormone therapy for an earlier cancer.
  • You are receiving hospice care.
  • Optional smaller study only: You use steroids or drugs that change the immune system on an ongoing basis. Steroids given before chemotherapy are allowed.
  • Optional smaller study only: You have a history of HIV, hepatitis B, or hepatitis C.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (483)

AK

AR

AZ

CA

CO

DE

FL

GA

HI

IA

ID

IL

IN

KS

KY

LA

MD

ME

MI

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MO

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NC

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NJ

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NY

OH

OK

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PA

SC

SD

TN

VA

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WA

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WV