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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02033 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000668836 | |||
| GOG-0247 | Other Identifier | Gynecologic Oncology Group | |
| GOG-0247 | Other Identifier | DCP | |
| GOG-0247 | Other Identifier | CTEP | |
| U10CA101165 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (limited participation) | 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Chart Review | Other | Patients' medical record information is collected and staff complete the treatment review form |
|
| 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 |
| 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. |
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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)
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
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Patients With Primary or Recurrent Uterine, Endometrial, or Cervical Cancer
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Brooks | Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Oncology Group of Arizona | Phoenix | Arizona | 85012 | United States | ||
| University of Arizona Cancer Center-North Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25937529 | Derived | Brooks SE, Carter RL, Plaxe SC, Basen-Engquist KM, Rodriguez M, Kauderer J, Walker JL, Myers TK, Drake JG, Havrilesky LJ, Van Le L, Landrum LM, Brown CL. Patient and physician factors associated with participation in cervical and uterine cancer trials: an NRG/GOG247 study. Gynecol Oncol. 2015 Jul;138(1):101-8. doi: 10.1016/j.ygyno.2015.04.033. Epub 2015 Apr 30. |
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| Questionnaire Administration | Other | Ancillary studies |
|
| 7 months |
| Tucson |
| Arizona |
| 85719 |
| United States |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | 91505 | United States |
| Roy and Patricia Disney Family Cancer Center | Burbank | California | 91505 | United States |
| John Muir Medical Center-Concord Campus | Concord | California | 94520 | United States |
| University of California San Diego | San Diego | California | 92103 | United States |
| John Muir Medical Center-Walnut Creek | Walnut Creek | California | 94598 | United States |
| Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut | 06105 | United States |
| The Hospital of Central Connecticut | New Britain | Connecticut | 06050 | United States |
| Florida Hospital Orlando | Orlando | Florida | 32803 | United States |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | United States |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | 83706 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453-2699 | United States |
| Elkhart Clinic | Elkhart | Indiana | 46514-2098 | United States |
| Michiana Hematology Oncology PC-Elkhart | Elkhart | Indiana | 46514 | United States |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | United States |
| Community Howard Regional Health | Kokomo | Indiana | 46904 | United States |
| IU Health La Porte Hospital | La Porte | Indiana | 46350 | United States |
| Michiana Hematology Oncology PC-Mishawaka | Mishawaka | Indiana | 46545 | United States |
| Saint Joseph Regional Medical Center-Mishawaka | Mishawaka | Indiana | 46545 | United States |
| Michiana Hematology Oncology PC-Plymouth | Plymouth | Indiana | 46563 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| Michiana Hematology Oncology PC-South Bend | South Bend | Indiana | 46601 | United States |
| Northern Indiana Cancer Research Consortium | South Bend | Indiana | 46628 | United States |
| Michiana Hematology Oncology PC-Westville | Westville | Indiana | 46391 | United States |
| Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa | 50325 | United States |
| Mercy Cancer Center-West Lakes | Clive | Iowa | 50325 | United States |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| Iowa-Wide Oncology Research Coalition NCORP | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates-Laurel | Des Moines | Iowa | 50314 | United States |
| Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | United States |
| Methodist West Hospital | West Des Moines | Iowa | 50266-7700 | United States |
| Mercy Medical Center-West Lakes | West Des Moines | Iowa | 50266 | United States |
| Hospital District Sixth of Harper County | Anthony | Kansas | 67003 | United States |
| Cancer Center of Kansas - Chanute | Chanute | Kansas | 66720 | United States |
| Cancer Center of Kansas - Dodge City | Dodge City | Kansas | 67801 | United States |
| Cancer Center of Kansas - El Dorado | El Dorado | Kansas | 67042 | United States |
| Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | 66701 | United States |
| Cancer Center of Kansas-Independence | Independence | Kansas | 67301 | United States |
| Cancer Center of Kansas-Kingman | Kingman | Kansas | 67068 | United States |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | United States |
| Cancer Center of Kansas-Liberal | Liberal | Kansas | 67905 | United States |
| Cancer Center of Kansas - McPherson | McPherson | Kansas | 67460 | United States |
| Cancer Center of Kansas - Newton | Newton | Kansas | 67114 | United States |
| Cancer Center of Kansas - Parsons | Parsons | Kansas | 67357 | United States |
| Cancer Center of Kansas - Pratt | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas - Salina | Salina | Kansas | 67401 | United States |
| Cancer Center of Kansas - Wellington | Wellington | Kansas | 67152 | United States |
| Associates In Womens Health | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas - Wichita | Wichita | Kansas | 67214 | United States |
| Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| Wichita NCI Community Oncology Research Program | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas - Winfield | Winfield | Kansas | 67156 | United States |
| Norton Hospital Pavilion and Medical Campus | Louisville | Kentucky | 40202 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | 48106-0995 | United States |
| Michigan Cancer Research Consortium NCORP | Ann Arbor | Michigan | 48106 | United States |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | United States |
| Spectrum Health Big Rapids Hospital | Big Rapids | Michigan | 49307 | United States |
| Beaumont Hospital-Dearborn | Dearborn | Michigan | 48124 | United States |
| Saint John Hospital and Medical Center | Detroit | Michigan | 48236 | United States |
| Green Bay Oncology - Escanaba | Escanaba | Michigan | 49829 | United States |
| Hurley Medical Center | Flint | Michigan | 48502 | United States |
| Genesys Regional Medical Center-West Flint Campus | Flint | Michigan | 48532 | United States |
| Cancer Research Consortium of West Michigan NCORP | Grand Rapids | Michigan | 49503 | United States |
| Mercy Health Saint Mary's | Grand Rapids | Michigan | 49503 | United States |
| Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | 49503 | United States |
| Green Bay Oncology - Iron Mountain | Iron Mountain | Michigan | 49801 | United States |
| Allegiance Health | Jackson | Michigan | 49201 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| Sparrow Hospital | Lansing | Michigan | 48912 | United States |
| Saint Mary Mercy Hospital | Livonia | Michigan | 48154 | United States |
| Mercy Health Mercy Campus | Muskegon | Michigan | 49444 | United States |
| Michiana Hematology Oncology PC-Niles | Niles | Michigan | 49120 | United States |
| Saint Joseph Mercy Oakland | Pontiac | Michigan | 48341 | United States |
| Saint Joseph Mercy Port Huron | Port Huron | Michigan | 48060 | United States |
| Saint Mary's of Michigan | Saginaw | Michigan | 48601 | United States |
| Lakeland Hospital | Saint Joseph | Michigan | 49085 | United States |
| Marie Yeager Cancer Center | Saint Joseph | Michigan | 49085 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| Saint John Macomb-Oakland Hospital | Warren | Michigan | 48093 | United States |
| Metro Health Hospital | Wyoming | Michigan | 49519 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Fairview-Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Hutchinson Area Health Care | Hutchinson | Minnesota | 55350 | United States |
| Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | 55109 | United States |
| Saint John's Hospital - Healtheast | Maplewood | Minnesota | 55109 | United States |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| North Memorial Medical Health Center | Robbinsdale | Minnesota | 55422 | United States |
| Metro Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota | 55416 | United States |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| Saint Francis Regional Medical Center | Shakopee | Minnesota | 55379 | United States |
| Lakeview Hospital | Stillwater | Minnesota | 55082 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| Rice Memorial Hospital | Willmar | Minnesota | 56201 | United States |
| Minnesota Oncology and Hematology PA-Woodbury | Woodbury | Minnesota | 55125 | United States |
| Saint Dominic-Jackson Memorial Hospital | Jackson | Mississippi | 39216 | United States |
| Singing River Hospital | Pascagoula | Mississippi | 39581 | United States |
| Phelps County Regional Medical Center | Rolla | Missouri | 65401 | United States |
| Cancer Research for the Ozarks NCORP | Springfield | Missouri | 65804 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Women's Cancer Center of Nevada | Las Vegas | Nevada | 89169 | United States |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07101 | United States |
| State University of New York Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Southeast Clinical Oncology Research (SCOR) Consortium NCORP | Winston-Salem | North Carolina | 27104 | United States |
| Summa Akron City Hospital/Cooper Cancer Center | Akron | Ohio | 44304 | United States |
| Akron General Medical Center | Akron | Ohio | 44307 | United States |
| Aultman Health Foundation | Canton | Ohio | 44710 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| Lake University Ireland Cancer Center | Mentor | Ohio | 44060 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Oklahoma Cancer Specialists and Research Institute-Tulsa | Tulsa | Oklahoma | 74146 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Geisinger Medical Center-Cancer Center Hazleton | Hazleton | Pennsylvania | 18201 | United States |
| Paoli Memorial Hospital | Paoli | Pennsylvania | 19301 | United States |
| Gynecologic Oncology Group | Philadelphia | Pennsylvania | 19103 | United States |
| Geisinger Medical Group | State College | Pennsylvania | 16801 | United States |
| Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | United States |
| Main Line Health NCORP | Wynnewood | Pennsylvania | 19096 | United States |
| Women and Infants Hospital | Providence | Rhode Island | 02905 | United States |
| AnMed Health Cancer Center | Anderson | South Carolina | 29621 | United States |
| AnMed Health Hospital | Anderson | South Carolina | 29621 | United States |
| Greenville Health System Cancer Institute-Faris | Greenville | South Carolina | 29605 | United States |
| Greenville Health System Cancer Institute-Eastside | Greenville | South Carolina | 29615 | United States |
| Greenville Health System Cancer Institute-Seneca | Seneca | South Carolina | 29672 | United States |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Greenville Health System Cancer Institute-Spartanburg | Spartanburg | South Carolina | 29307 | United States |
| Sanford Cancer Center-Oncology Clinic | Sioux Falls | South Dakota | 57104 | United States |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | United States |
| The Methodist Hospital System | Houston | Texas | 77030 | United States |
| Scott and White Memorial Hospital | Temple | Texas | 76508 | United States |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | United States |
| Green Bay Oncology at Saint Vincent Hospital | Green Bay | Wisconsin | 54301-3526 | United States |
| Saint Vincent Hospital | Green Bay | Wisconsin | 54301 | United States |
| Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay | Wisconsin | 54303 | United States |
| Saint Mary's Hospital | Green Bay | Wisconsin | 54303 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| Holy Family Memorial Hospital | Manitowoc | Wisconsin | 54221 | United States |
| Bay Area Medical Center | Marinette | Wisconsin | 54143 | United States |
| D N Greenwald Center | Mukwonago | Wisconsin | 53149 | United States |
| Oconomowoc Memorial Hospital-ProHealth Care Inc | Oconomowoc | Wisconsin | 53066 | United States |
| Green Bay Oncology - Oconto Falls | Oconto Falls | Wisconsin | 54154 | United States |
| Door County Cancer Center | Sturgeon Bay | Wisconsin | 54235-1495 | United States |
| Green Bay Oncology - Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235 | United States |
| Waukesha Memorial Hospital | Waukesha | Wisconsin | 53188 | United States |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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