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

May 16, 2024 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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) PD-1, PD-L1 or CTLA-4.

Participants complete surveys and have their medical records reviewed on study.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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)

Description

Inclusion Criteria:

Patient

  • 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.
  • Planned treatment with systemic chemotherapy (single or multi-agent, includes targeted therapy) with or without immune checkpoint inhibitor therapy (targeting PD-1, PD-L1 or CTLA-4). If unable to engage patient before treatment starts, enrollment is allowed from diagnosis up to four weeks after the start of treatment but must be before cycle 2 treatment begins.
  • Patients must be able to comprehend English or Spanish (for survey completion).
  • Patients 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.

Patient Optional Substudy (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 receiving paclitaxel as part of their chemotherapy in conjunction with ICIs PD-1, PDL1 or CTLA.
  • Must be enrolled before cycle 1 begins

Exclusion Criteria:

Patient

* Currently enrolled in an interventional supportive treatment trial to manage cancer symptoms.

Patient Optional Substudy (available at select sites only):

  • Patients with chronic or ongoing steroid or immunomodulatory agents (i.e., prednisone, dexamethasone, etanercept, infliximab, etc.).
  • Patients with a history of HIV, hepatitis B or hepatitis C.
  • Patients with active infection who are receiving antibiotic, antifungal or antiviral treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Participants complete surveys and have their medical records reviewed on study.
Other: Non-interventional Study
Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer-related symptoms
Time Frame: Baseline and re-assessed monthly up to 12 months post-enrollment
Will use the National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events to measure cancer-related symptoms. Will examine the longitudinal relationship between cannabis and/or cannabinoid use and the likelihood of exhibiting individual symptoms using three-level GLMMs to account for the nested data. We will model continuous measures (e.g., symptom severity) using a linear generalized linear mixed-effects models (GLMM) and the prevalence of symptoms or moderate to severe symptoms using a logistic GLMM. Cannabis and/or cannabinoid use at each monthly assessment will be included as a time-varying covariate and an interaction with time will be included to assess its impact on symptoms over time. Analyses will consider dichotomous definitions of use (yes/no past month), frequency of use (# days in the past month) as well as mode of administration, dose/potency, and cannabinoid type.
Baseline and re-assessed monthly up to 12 months post-enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 will be measured monthly using items from the Cannabis Engagement Assessment (CEA). The CEA contains 30 questions that assess the quantity, frequency of use, and method of consumption for dried cannabis products (excluding edibles), cannabis concentrates, and edible products in the previous 30 days. Two additional sections assess other factors associated with cannabis use and history of use. Estimates of consumption can be calculated from responses, with a lower limit of 0 and no upper limit. Higher values represent higher consumption in that month.
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 use will be measured monthly using items from the International Cannabis Policy Study (ICPS) survey. The ICPS surveys provide a comprehensive assessment of cannabis use, includes detailed patterns of consumption, purchasing, adverse outcomes, as well as attitudes and beliefs towards cannabis. Results from this survey will help quantify amount of cannabis use, if any.
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
The NCI Cannabis Core Measures survey will be used to ask cannabis and cannabinoid users each month whether they think cannabis or cannabinoid use worsened or improved their symptoms. Using the NCI Cannabis Core Measures survey, we will ask cannabis and cannabinoid users each month whether they think cannabis or cannabinoid use worsened or improved their symptoms. We will define this as a nominal outcome where 0=no change; 1=worsened quite a bit or somewhat worsened, and 2=somewhat improved or improved quite a bit.
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
The Adverse Reactions Scale will be used to ask cannabis and cannabinoid users each month whether they have experienced a checklist of potential adverse reactions. We will participants using cannabis and/or cannabinoids each month whether they have experienced a checklist of potential adverse reactions. These are defined as presence or absence of the adverse effect. We will also consider the frequency of time they experience the effect (% of time they experience the effect when consuming cannabis or cannabinoids) and the severity of the effect (0 = Not at all distressing; 1 = Mildly distressing; 2 = Moderately distressing; 3 = Quite distressing 4 = Severely distressing) as continuous measures.
Baseline and re-assessed monthly up to 12 months post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Glenn Lesser, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WF-2304 (Other Identifier: Lead Organization Identifier)
  • 5UG1CA189824 (U.S. NIH Grant/Contract)
  • NCI-2024-03314 (Other Identifier: NCI Trial Identifier)
  • 1U01CA286813 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.

IPD Sharing Time Frame

6 months after publication for a 2 year duration

IPD Sharing Access Criteria

upon request to NCORP@wakehealth.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Melanoma

Clinical Trials on Non-interventional Study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe