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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Recurrent Cervical Carcinoma, Recurrent Uterine Corpus Carcinoma, Recurrent Uterine Corpus Sarcoma, Stage I Uterine Corpus Cancer, Stage I Uterine Sarcoma, Stage IA Cervical Cancer, Stage IB Cervical Cancer, Stage II Uterine Corpus Cancer, Stage II Uterine Sarcoma, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage III Uterine Corpus Cancer, Stage III Uterine Sarcoma, Stage IV Uterine Corpus Cancer, Stage IV Uterine Sarcoma, Stage IVA Cervical Cancer, Stage IVB Cervical Cancer

Intervention / Treatment
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* Other: Medical Chart Review
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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) 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I (limited participation)<br>Patients do not complete any questionnaires 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. | Other: Medical Chart Review<br>* Patients' medical record information is collected and staff complete the treatment review form<br>* Other names: Chart Review;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Group II (full participation)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment status | Will be analyzed using categorical variable modeling methods. Logistic response functions will be used. | 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. | 7 months |