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
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.
Inclusion Criteria:
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)
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
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
Burbank, California 91505, United States
Saint Louis Park, Minnesota 55416, United States
Winston-Salem, North Carolina 27104, United States
Spartanburg, South Carolina 29307, United States