A Study in Patients Reporting Cannabis Use Followed With an Application-Based Cannabis Journal
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Primary outcome measures
- Cannabis Use [Time frame: Enrollment + 6 months]
Secondary outcome measures (1)
- Patient Reported Symptoms [Time frame: Enrollment + 6 months]
Eligibility criteria
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:
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07089225 · 20250219.1100 · 5UG1CA189824