Patient, Physician And Nurse Factors Associated With Entry Onto Clinical Trials And Completion Of Treatment For Women With Primary Or Recurrent Invasive Cancer Of The Uterine Corpus Or Uterine Cervix, All Stages
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 778
- 试验地点
- 167
- 主要终点
- Predictive value of modifiable patient, physician, or clinical trial specific factors on enrollment or non-enrollment onto a treatment clinical trial
研究概览
简要总结
This clinical trial is studying patient, physician, and nurse factors associated with entry onto clinical trials and finishing treatment in patients with primary or recurrent uterine, endometrial, or cervical cancer. Determining how patients make decisions about participating in a clinical trial may help doctors plan clinical trials in which more patients are willing to participate and are satisfied with their decision to participate.
详细描述
PRIMARY OBJECTIVES:
I. To determine if there are specific, modifiable factors relative to patients, physicians, nurses, or clinical trial designs that predict enrollment or non-enrollment onto a GOG therapeutic trial for patients with primary or recurrent invasive cancer of the uterine corpus or cervix.
II. To determine if the Functional Comorbidity Index is an independent predictor of enrollment in a GOG clinical trial and if it correlates with performance status.
SECONDARY OBJECTIVES:
I. To determine, through multivariate analyses, whether the distribution of patients into a GOG clinical trial entry status categories (i.e., enrolled, not enrolled but eligible, not eligible) varies by demographics or economic status of patients, by patients' beliefs/concerns and interactions with physicians/family and friends, or by nurses' or physicians' beliefs/concerns and interactions with patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meets 1 of the following criteria:
- •Patients with a pathologically confirmed diagnosis of a primary or recurrent invasive cancer of the uterine cervix or uterine corpus (all stages)
- •Further treatment is indicated
- •Treatment must take place at the GOG institution in which the patient is enrolled
- •A GOG physician, nurse, or study coordinator for one of the patients described above
- •Any GOG performance status
- •Meets 1 of the following criteria:
- •Willing and able to complete or be assisted with completion of 2 questionnaires and have limited medical history, treatment details, and demographic data collected
- •Patients do not have to speak and write English (can be assisted by an interpreter)
- •Willing to have limited medical history, treatment details, and demographic data collected (Patient)
- •No patients who refuse treatment
- •No concurrent treatment in a GOG treatment trial
- •Prior participation in a GOG treatment trial allowed
排除标准
- 未提供
结局指标
主要结局
Predictive value of modifiable patient, physician, or clinical trial specific factors on enrollment or non-enrollment onto a treatment clinical trial
时间窗: 7 months
Two-sided Mann-Whitney U-tests will be performed.
Predictive value of the Functional Comorbidity Index on whether a patient is enrolled in a clinical trial
时间窗: 7 months
A logistic regression model analysis will be used.
次要结局
- Patient/physician demographics(7 months)
- Enrollment status(7 months)