Clinical trial · Observational
A Study in Patients Reporting Cannabis Use Followed With an Application-Based Cannabis Journal
A Pilot Companion Cancer Cohort Study to the Wake Forest COSMIC Study (WF-2304) in Patients Reporting Cannabis Use Followed With an Application-Based Cannabis Journal
NCT07089225CI-TRIAL-00095688COSMIC- Releafnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being done because there is a significant lack of data on the use of cannabis amongst cancer patients. The investigators believe that the collection of this data will help researchers and clinicians better understand the needs and the impact of cannabis use in this specific patient population.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Cannabis Use
- timeFrame
- Enrollment + 6 months
- description
- In patients who report using cannabis, investigators will measure frequency and dose of cannabis and cannabinoid use, purpose of use (i.e., seeking recreational vs. medicinal effects), type (e.g., flower, concentrate, edibles), route of administration (e.g., smoking, vaping, ingestion, tincture, oil), psychoactive and non-psychoactive content (THC vs. CBD/CBG/CBN content in product), and products sources (from medical dispensaries and/or regulated adult-use stores).
Secondary outcomes (1)
- measure
- Patient Reported Symptoms
- timeFrame
- Enrollment + 6 months
- description
- Investigators will measure patient-reported helpful and adverse effects of cannabis and cannabinoid use among cancer patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients must be 18 years of age or older and able to give verbal informed consent to participate.
* Patients must be able to speak, read and understand English.
* Patients must report use of cannabis at time of study participation.
* Patients must have access to internet and ability to download Releaf™ App (MoreBetter, Ltd.) to a smartphone or tablet and must use Releaf™ App (MoreBetter, Ltd.) for cannabis journaling.
* Patients must be able to send and receive text messages, and be able to interact with web-pages on smartphone or tablet.
* There are 2 scenarios that patients are eligible for participation, and are listed below:
1. Patients must have a cancer diagnosis for which they are receiving active therapy defined as follows:
* Surgery - must be within a 30-day pre- and/or post-operative (peri-operative) window if single modality of care. Patients must be 18 years of age or older and able to give verbal informed consent to participate.
* Radiation - must be within a 30-day pre- (simulation planning phase) and/or post-radiation window if single modality of care.
* Any anticancer systemic therapy including hormonal, biologic, targeted, and/or cytotoxic chemotherapy. Understandably, numerous patients recruited under surgery and/or radiation will receive systemic therapy as part of combined modality therapy, which is permissible. Regardless, all details regarding cancer diagnosis, stage, and treatment will be collected from the EMR, which will be detailed in the informed consent document.
2. Any patient in follow-up by their primary oncology care provider and/or AYA and cardio-oncology survivorship clinic(s).
* All patients must be treated within the MHCCN thus ensuring access to clinical data in our system-wide EMR (Epic).
* Patients must obtain their cannabis either from a medical-use store, adult-use (recreational) store or both. Patients must obtain cannabis ONLY from medical/recreational stores. Illicit (or homegrown) sources are strictly prohibited.References
Publications (0)
Data not yet available
No reference posted for this study.