Recurrent Cervical Carcinoma Clinical Trial
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
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.
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