NCT07089225

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

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Sep 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Sep 2025Dec 2026

First Submitted

Initial submission to the registry

July 15, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 30, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

July 15, 2025

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Scot Remick, MD

    MaineHealth

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coodinator

CONTACT

Research Program Manager

CONTACT

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