## Protocol Section
### Identification Module
**NCT ID:** NCT06418204

**Acronym:** COSMIC

**Brief Title:** 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

#### Organization Study ID Info
**ID:** WF-2304
#### Organization
**Class:** OTHER
**Full Name:** Wake Forest University Health Sciences
#### Secondary ID Infos
**Domain:** NCI Trial Identifier
**ID:** NCI-2024-03314
**Type:** OTHER
**Domain:** Lead Organization Identifier
**ID:** WF-2304
**Type:** OTHER
**ID:** 5UG1CA189824
**Link:** https://reporter.nih.gov/quickSearch/5UG1CA189824
**Type:** NIH
**ID:** 1U01CA286813
**Link:** https://reporter.nih.gov/quickSearch/1U01CA286813
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2028-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2028-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-08

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** Wake Forest University Health Sciences

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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.

**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.

### Conditions Module

**Conditions:**

- Breast Carcinoma

- Colorectal Carcinoma

- Lung Non-Small Cell Carcinoma

- Melanoma

- Non-Hodgkin Lymphoma

### Design Module

#### Bio Spec

**Description:** About one tablespoon (15mL) of blood will be collected from a vein in the participant's arm at 3 different time points.

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 2000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Non-interventional Study

**Label:** Observational

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Observational

**Description:** Non-interventional study

**Name:** Non-interventional Study

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Cancer-related symptoms

**Time Frame:** Baseline and re-assessed monthly up to 12 months post-enrollment

#### Secondary Outcomes

**Description:** 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.

**Measure:** Cannabis and Cannabinoid Use from Cannabis Engagement Assessment

**Time Frame:** Baseline and re-assessed monthly up to 12 months post-enrollment

**Description:** 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.

**Measure:** Cannabis and Cannabinoid Use from the International Cannabis Policy Study survey

**Time Frame:** Baseline and re-assessed monthly up to 12 months post-enrollment

**Description:** 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.

**Measure:** Cannabis and Cannabinoid Perceived Benefits and Harms

**Time Frame:** Baseline and re-assessed monthly up to 12 months post-enrollment

**Description:** 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.

**Measure:** Cannabis and Cannabinoid Adverse Effects

**Time Frame:** Baseline and re-assessed monthly up to 12 months post-enrollment

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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)

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** NCORP@wakehealth.edu

**Name:** Karen Craver

**Phone:** 336-716-0891

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Wake Forest University Health Sciences

**Name:** Glenn Lesser, MD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**Access Criteria:** upon request to NCORP@wakehealth.edu

**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:** YES

**Time Frame:** 6 months after publication for a 2 year duration

**URL:** http://nctn-data-archive.nci.nih.gov/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000012871

- Term: Skin Diseases

- ID: D000001941

- Term: Breast Diseases

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

- ID: D000002283

- Term: Carcinoma, Bronchogenic

- ID: D000001984

- Term: Bronchial Neoplasms

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5546

- Name: Carcinoma, Non-Small-Cell Lung

- Relevance: HIGH

- As Found: Lung Non-Small Cell Carcinoma

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Carcinoma

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M11220

- Name: Lymphoma

- Relevance: LOW

- As Found: Unknown

- ID: M11528

- Name: Melanoma

- Relevance: LOW

- As Found: Unknown

- ID: M5449

- Name: Marijuana Abuse

- Relevance: LOW

- As Found: Unknown

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: HIGH

- As Found: Colorectal Carcinoma

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5540

- Name: Carcinoma, Bronchogenic

- Relevance: LOW

- As Found: Unknown

- ID: M5260

- Name: Bronchial Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000015179

- Term: Colorectal Neoplasms

- ID: D000002289

- Term: Carcinoma, Non-Small-Cell Lung

### Misc Info Module

- Version Holder: 2024-05-31
