Cannabis Use and Outcomes in Black and White Patients With Cancer

NCT ID: NCT06037681

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-30
• Study Completion Date: 2027-03-30

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.

Detailed Description

Using an observational design with momentary ecological assessment on a smartphone app (mEMA), The investigators propose a strong prospective cohort design with repeated-measures for 12 months regarding patients with cancer and their pain, use of opioids and cannabis. The design was selected to allow for real-time, real-world assessments, while minimizing risks due to attrition and burden to the participants. The staff will enroll 100 cannabis users (50 African American, 50 White) and 100 cannabis non-users (50 African American, 50 White) diagnosed with cancer in the last 3 years and prescribed opioids from each of the three sites, University of Pennsylvania, PA, University at Buffalo, NY and Thomas Jefferson University, PA. Assessments will begin at Baseline (Month 0) and continue for 12 months. To reduce participant burden in terms of travel time, cost and inconvenience, patients will complete measures remotely via video/phone at 12 time points (Months 1-12). Daily measures of pain, cannabis and opioid use will be collected via EMA for one week per month for 12 months. Patients will report on multiple indices of cannabis use. Opioid prescription information and other covariates and potential moderators will be collected over the 12-month study period. Many factors affect opioid use, there is little insight into the longitudinal impact of cannabis use on when or how often patients self-dose opioids. EMA will give much needed insight into when and why cannabis users do or do not take opioids. Moreover, the focus on the co-use of cannabis and opioids allows better understanding of the interplay and timing in self-administration of one or both.

Conditions

Cancer

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

Black cannabis users

African Americans that use cannabis at least once a week

No interventions assigned to this group

Black non-cannabis users

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

No interventions assigned to this group

White cannabis users

Caucasians that use cannabis at least once a week

No interventions assigned to this group

White non-cannabis users

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 21 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Ashare

Co- Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salimah Meghani, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Brooke Worster, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Rebecca L Ashare, PhD

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo

Locations

University at Buffalo

Buffalo, New York, United States

Site Status: RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Colleen Kilanowski, MS

Role: CONTACT

ckk@buffalo.edu

716-829-5977

Rebecca L Ashare, BA

Role: CONTACT

rlashare@buffalo.edu

716-829-2024

Facility Contacts

Colleen Kilanowski, MS

Role: primary

ckk@buffalo.edu

716-829-5977

Rebecca Ashare, PhD

Role: backup

rlashare@buffalo.edu

716-829-2024

Brooke Worster, MD

Role: primary

Brooke.Worster <Brooke.Worster@jefferson.edu>

215-955-1888

Amy Leader, MPH

Role: backup

Amy.Leader@jefferson.edu;

215-955-7739

Andy Robinson

Role: primary

arobins2@nursing.upenn.edu

215-746-7335

Salimah Meghani, PhD

Role: backup

salimahm@nursing.upenn.edu

512-573-7128

Other Identifiers

1174865

Identifier Type: -

Identifier Source: org_study_id