Cannabis Use and Outcomes in Black and White Patients With Cancer (C4C)

University at Buffalo (UB)

Status: Enrolling

Conditions: Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06037681

1174865

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 4 patient groups

Black cannabis users

Description:

African Americans that use cannabis at least once a week

Black non-cannabis users

Description:

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

White cannabis users

Description:

Caucasians that use cannabis at least once a week

White non-cannabis users

Description:

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