Clinical trial NCT06037681: Cannabis Use and Outcomes in Black and White Patients With Cancer
Official title: Cannabis Use and Outcomes in Black and White Patients With Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Solid tumor, opioids, cannabis
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Thomas Jefferson University
First posted: 2023-09-14
Enrollment: 600
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Change from baseline of Cannabis use
timeFrame: Baseline to 12 months
measure: Cannabis use and patient reported outcomes and opioid use
timeFrame: Baseline to 12 months
measure: Cannabis use moderate the associations between race and pain
timeFrame: Baseline to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Salimah Meghani, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University
name: Brooke Worster, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University at Buffalo
name: Rebecca L Ashare, PhD
role: PRINCIPAL_INVESTIGATOR
References: