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.
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. II. To determine whether patients' beliefs/concerns or interactions are associated with patient, nurse, or physician demographics. III. To determine whether physicians' beliefs/concerns or interactions are associated with patient or physician demographics. IV. To perform descriptive analysis regarding factors associated with completion of treatment through analysis of the Treatment Review Form. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups. GROUP I (limited participation): Patients do not complete any questionnaires at baseline. GROUP II (full participation): Patients complete the Patient Registration Survey and Patient Questionnaire at baseline. 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. Staff complete the treatment review form after treatment or 7 months after study registration.
Study Type
OBSERVATIONAL
Enrollment
778
Patients' medical record information is collected and staff complete the treatment review form
Ancillary studies
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Roy and Patricia Disney Family Cancer Center
Burbank, California, United States
John Muir Medical Center-Concord Campus
Concord, California, United States
Predictive value of modifiable patient, physician, or clinical trial specific factors on enrollment or non-enrollment onto a treatment clinical trial
Two-sided Mann-Whitney U-tests will be performed.
Time frame: 7 months
Predictive value of the Functional Comorbidity Index on whether a patient is enrolled in a clinical trial
A logistic regression model analysis will be used.
Time frame: 7 months
Enrollment status
Will be analyzed using categorical variable modeling methods. Logistic response functions will be used.
Time frame: 7 months
Patient/physician demographics
Logistic regression analyses for ordinal categorical outcomes with more than two categories will be used to test the association of patient/physician responses with patient/physician demographics. All tests will be two-sided likelihood ration Chi-Square tests.
Time frame: 7 months
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