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
Status: | Completed |
---|---|
Conditions: | Cervical Cancer, Cancer, Cancer, Women's Studies, Endometrial Cancer |
Therapuetic Areas: | Oncology, Reproductive |
Healthy: | No |
Age Range: | Any |
Updated: | 4/17/2018 |
Start Date: | July 2010 |
End Date: | January 27, 2018 |
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.
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.
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)
- 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
We found this trial at
167
sites
Cancer Center of Kansas, PA - Liberal Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Akron General Medical Center It
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Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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Aultman Health Foundation The Aultman Foundation will raise and administer funds in order to support...
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Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Mercy Medical Center - Des Moines Mercy Medical Center
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Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
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Iowa Lutheran Hospital Iowa Lutheran Hospital has a long history of serving the Des Moines...
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Saint John Hospital and Medical Center Founded in 1952, St. John Hospital and Medical Center...
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Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
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Elkhart Clinic, LLC Informed participation in the management of your health care maximizes your Elkhart...
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Michiana Hematology-Oncology The Advanced Center for Cancer Care in Plymouth is part of the Cancer...
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420 S Saginaw St
Flint, Michigan 48502
Flint, Michigan 48502
810-232-3522
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Cancer Center of Kansas - Fort Scott Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Unity Hospital Unity Hospital is one of the Twin Cities
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1726 Shawano Ave.
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54303
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Green Bay, Wisconsin 54301
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Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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5340 Holy Cross Pkwy
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(574) 237-1328
Michiana Hematology Oncology PC-Mishawaka Michiana Hematology Oncology's Advanced Centers for Cancer Care include the largest...
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The Hospital of Central Connecticut The Hospital of Central Connecticut is dedicated to fostering, sustaining...
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Cancer Center of Kansas, PA - Newton Dr. H.E. Hynes founded Cancer Center of Kansas,...
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4 Longmeadow Village Dr
Niles, Michigan 49120
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(269) 683-4153
Michiana Hematology Oncology PC - Niles In 1968, medical oncologist Thomas Troeger, MD had a...
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Advocate Christ Medical Center Advocate Health Care, named among the nation
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791 Summit Avenue
Oconomowoc, Wisconsin 53066
Oconomowoc, Wisconsin 53066
262-569-9400
Oconomowoc Memorial Hospital-ProHealth Care Inc ProHealth Care is a community-based health care system that offers...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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