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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 主要终点
- Cannabis Use
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Cannabis Use
时间窗: 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).
次要结局
- Patient Reported Symptoms(Enrollment + 6 months)
研究者
Scot Remick
Oncology Research and Education Principal
MaineHealth