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
RATIONALE: 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.
PURPOSE: 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.
Other: communication analysis
Other: medical chart review
Other: questionnaire administration
Other: study of socioeconomic and demographic variables
|Study Design:||Primary Purpose: Health Services Research|
|Official Title:||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|
- Predictive value of modifiable patient, physician, or clinical trial specific factors on enrollment or non-enrollment onto a treatment clinical trial [ Designated as safety issue: No ]
- Predictive value of the Functional Comorbidity Index on whether a patient is enrolled in a clinical trial [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
- 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.
- 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.
- 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.
- To determine whether patients' beliefs/concerns or interactions are associated with patient, nurse, or physician demographics.
- To determine whether physicians' beliefs/concerns or interactions are associated with patient or physician demographics.
- To perform descriptive analysis regarding factors associated with completion of treatment through analysis of the Treatment Review Form.
OUTLINE: This is a multicenter study.
At baseline, patients' medical record information is collected; sites complete the Functional Comorbidity Index; and physicians, nurses, and study coordinators complete the follow-up questionnaire. Patients may also complete the Patient Registration Survey and Patient Questionnaire at baseline. Staff complete the treatment review form after treatment or 7 months after study registration.