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NCT Number: NCT07089225

A Study in Patients Reporting Cannabis Use Followed With an Application-Based Cannabis Journal

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Cannabis Use

    Time frame: Enrollment + 6 months

    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. Patient Reported Symptoms

    Time frame: Enrollment + 6 months

    Investigators will measure patient-reported helpful and adverse effects of cannabis and cannabinoid use among cancer patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Research Coodinator

CONTACT

[email protected]

207-550-1265

Research Program Manager

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Scot Remick

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Acronym: COSMIC- Releaf

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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