A Multicenter Prospective Observational Cohort Study Evaluating the Impact of Cancer-Directed Treatment and Medication Use, Including Cannabis Use, in Multiple Myeloma Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 11
- 主要终点
- Potential therapeutic benefit and adverse effects associated with cannabis use
研究概览
简要总结
This study assesses the impact of cannabis (also commonly called marijuana, weed, or THC) use on quality of life among patients with multiple myeloma who are receiving chemotherapy. It also evaluates the potential benefits and harms of cannabis use.
详细描述
PRIMARY OBJECTIVES:
I. Characterize and compare longitudinal patterns in quality of life, as assessed by the Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) instrument, among cannabis users and non-users.
II. Estimate and characterize the potential therapeutic benefit and adverse effects associated with cannabis use as assessed by longitudinal patterns of patient reported symptoms (Edmonton Symptoms Assessment Scale-ESAS) and medical assessments (Common Terminology Criteria for Adverse Events-CTCAE v5.0) through a comparative analysis of users and non-users.
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
GROUP I: Patients complete surveys and undergo blood sample collection throughout the study.
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
- 是
入选标准
- •* Documented informed consent of the participant
- •Age: ≥ 18 years
- •Ability to read and understand English
- •Patient must be newly diagnosed with a histologically confirmed multiple myeloma
- •Patients may have started first line therapies and received up to four cycles
- •HCP SURVEY: Documented informed consent of the participant
- •HCP SURVEY: Age: ≥ 18 years
- •HCP SURVEY: Licensed physician, physician assistant, nurse practitioner, or registered nurse
- •HCP SURVEY: Currently practicing in oncology or providing direct care to oncology patients
- •HCP SURVEY: Able to read and understand English
- •HCP SURVEY: Affiliation with City of Hope
排除标准
- •* Patients may not have completed five cycles of first line therapy or undergone any second line therapy
- •Other active malignancy
- •Patients may not have undergone autologous hematopoietic stem cell transplantation
- •Unable to comply with the study assessments
- •HCP SURVEY: Reports directly to study PI (Dr. Richard Lee)
- •HCP SURVEY: Member of the study team or involved in survey design or analysis
- •HCP SURVEY: Individuals with a real or perceived conflict of interest that could bias survey responses
研究组 & 干预措施
Observational group II
Healthcare providers complete a survey on study.
干预措施: Non-Interventional Study (Other)
Observational group I
Patients complete surveys and undergo blood sample collection throughout the study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Potential therapeutic benefit and adverse effects associated with cannabis use
时间窗: Up to one year
Will estimate and characterize the potential therapeutic benefit and adverse effects associated with cannabis use as assessed by longitudinal patterns of patient reported symptoms (Edmonton Symptoms Assessment Scale-ESAS) through a comparative analysis of users and non-users. Descriptive statistics will be computed regarding reported benefits and harms of cannabis, and associations will be explored with the different type of cannabis utilized.
Longitudinal patterns in quality of life
时间窗: Up to one year
Will characterize and compare longitudinal patterns in quality of life, as assessed by the Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) instrument, among cannabis users and non-users. The analysis will compare difference scores from the FACT-MM between these groups using ANOVA at the end of treatment. For comparisons between groups at four specific assessment points (baseline, C1, C2, C3, and C4), a repeated measures analysis of variance analysis will be performed. Multivariable mixed-effects regression model, which takes possible dependence of longitudinal measurements within each subject into account, will be used. The possible within-subject dependence will also be taken into account using the robust standard error (generalized estimating equation method) when statistical inferences are made with regards to the treatment effect and interaction between treatment and time period.
次要结局
未报告次要终点