Cannabis Use and Outcomes in Black and White Patients With Cancer

NCT06037681 | Recruiting

• 1 other identifier: 1174865
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of the observational study is to learn how black and white patients with solid tumor cancer use cannabis, opioids and tobacco. The investigators are using momentary ecological assessment through a smart phone app and surveys to assess patient-reported pain and other symptoms as to inform clinical practice and guidelines for underrepresented populations.

Conditions

Cancer

Keywords

Solid tumor, opioids, cannabis

Outcome Measures

Primary Outcomes (3)

• Change from baseline of Cannabis use

  descriptive statistics will be generated for all cannabis-related variables across time \[frequency of use, composition (ratio of THC:CBD), indication, source (medical vs. non-medical), and route (inhalation/oral/topical)\]. Statistical comparisons will be made across key demographics (e.g., age, education, sex, race), cancer-related variables including cancer treatment status (active vs. completed), and other factors such as duration of opioid use (30-90 days vs. \>90 days).ecological momentary assessment questions

  Baseline to 12 months

• Cannabis use and patient reported outcomes and opioid use

  For all data collected via EMA (cannabis use, opioid use, pain severity, and pain-related function), data will be aggregated at the daily level (84 days of data). For data collected via monthly surveys (anxiety, sleep, QoL) and EMR and PDMP extraction, each timepoint of data collection will be used (10 total: Baseline, Months 1-6, 8, 10, 12). For all variables, change in PROs and opioid use will be tested using HLMs. First, nested model tests will be used to evaluate the shape of change in each outcome variable (e.g., linear, polynomial, piecewise, etc.) as well as relevant random effects. Next, cannabis use (level-2 predictor) will be introduced into the models and crossed with time. We will evaluate whether the shape of change for each outcome differs by cannabis use group.

  Baseline to 12 months

• Cannabis use moderate the associations between race and pain

  This will follow the same approach described for Aim 2 with the inclusion of race as a dummy coded level 2 predictor and crossing race with cannabis use and time to form interaction terms. Significant interaction terms will be probed following Preacher et al.131. African Americans are expected to experience higher levels of pain severity and less decline in pain severity over time, and we predict this disparity will be reduced among cannabis users.

  Baseline to 12 months

Study Arms (4)

Black cannabis users

African Americans that use cannabis at least once a week

Black non-cannabis users

African Americans that do not use cannabis for at least 3 months prior to enrollment

White cannabis users

Caucasians that use cannabis at least once a week

White non-cannabis users

Caucasians that do not use cannabis for at least 3 month prior to enrollment

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Black and White patients from Local cancer centers of the Buffalo, Univsity of Pennsylvania and Thomas Jefferson Univeristy areas.

You may qualify if:

• years or older
• Black or white race
• Solid tumor cancer within 3 years of enrollment
• Cannabis use of at least once a week or non cannabis use for 3 months
• experience pain but spend less than 50% in bed or chair
• Prescribed or take opioid for at least 30 days for pain
• Not pregnant or planning to become pregnant in the next 12 months
• English speaking

You may not qualify if:

• Lymphoma, leukemia, and melanoma
• CBD only use
• Synthetic cannabis use in past 3 months = Prescribed Medically-prescribed synthetic cannabis (e.g., dronabinol \[Marinol, Syndros\], Epidiolex)
• race other than Black or White

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• University of Pennsylvania: collaborator
• Thomas Jefferson University: collaborator

Study Sites (3)

University at Buffalo

Buffalo, New York, 14214, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19144, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19176, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Salimah Meghani, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Brooke Worster, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Rebecca L Ashare, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colleen Kilanowski, MS

CONTACT

716-829-5977; ckk@buffalo.edu

Rebecca L Ashare, BA

CONTACT

716-829-2024; rlashare@buffalo.edu

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co- Principal Investigator

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: March 30, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)