A Study in Patients Reporting Cannabis Use Followed With an Application-Based Cannabis Journal
COSMIC- Releaf
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
2 other identifiers
observational
45
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2025
CompletedFirst Posted
Study publicly available on registry
July 28, 2025
CompletedStudy Start
First participant enrolled
September 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
September 24, 2025
September 1, 2025
11 months
July 15, 2025
September 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Cannabis Use
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).
Enrollment + 6 months
Secondary Outcomes (1)
Patient Reported Symptoms
Enrollment + 6 months
Eligibility Criteria
Oncology patients, receiving active therapy or in follow up following active therapy, and treated within the MaineHealth Cancer Care Network (MHCCN).
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scot Remicklead
- National Cancer Institute (NCI)collaborator
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Scot Remick, MD
MaineHealth
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Oncology Research and Education Principal
Study Record Dates
First Submitted
July 15, 2025
First Posted
July 28, 2025
Study Start
September 30, 2025
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
September 24, 2025
Record last verified: 2025-09