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
This study is ongoing, but not recruiting participants.
Sponsor:
Gynecologic Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01098630
First received: April 2, 2010
Last updated: January 19, 2012
Last verified: January 2012
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Purpose
RATIONALE: 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.
PURPOSE: 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.
| Condition | Intervention |
|---|---|
|
Cervical Cancer Endometrial Cancer Sarcoma |
Other: communication analysis Other: medical chart review Other: questionnaire administration Other: study of socioeconomic and demographic variables |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Health Services Research |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Predictive value of modifiable patient, physician, or clinical trial specific factors on enrollment or non-enrollment onto a treatment clinical trial [ Designated as safety issue: No ]
- Predictive value of the Functional Comorbidity Index on whether a patient is enrolled in a clinical trial [ Designated as safety issue: No ]
| Estimated Enrollment: | 410 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- 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.
- 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
- 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.
- To determine whether patients' beliefs/concerns or interactions are associated with patient, nurse, or physician demographics.
- To determine whether physicians' beliefs/concerns or interactions are associated with patient or physician demographics.
- To perform descriptive analysis regarding factors associated with completion of treatment through analysis of the Treatment Review Form.
OUTLINE: This is a multicenter study.
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. Patients may also complete the Patient Registration Survey and Patient Questionnaire at baseline. Staff complete the treatment review form after treatment or 7 months after study registration.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
No concurrent treatment in a GOG treatment trial
- Prior participation in a GOG treatment trial allowed
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01098630
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| United States, California | |
| Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center | |
| Burbank, California, United States, 91505 | |
| Cancer Care Center at John Muir Health - Concord Campus | |
| Concord, California, United States, 94524-4110 | |
| Rebecca and John Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| John Muir/Mt. Diablo Comprehensive Cancer Center | |
| Walnut Creek, California, United States, 94598 | |
| United States, Connecticut | |
| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | |
| Hartford, Connecticut, United States, 06105 | |
| George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | |
| New Britain, Connecticut, United States, 06050 | |
| United States, Florida | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | |
| Orlando, Florida, United States, 32803-1273 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| Kapiolani Medical Center for Women and Children | |
| Honolulu, Hawaii, United States, 96826 | |
| MBCCOP - Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| Queen's Cancer Institute at Queen's Medical Center | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Idaho | |
| Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | |
| Boise, Idaho, United States, 83706 | |
| United States, Illinois | |
| Advocate Christ Medical Center | |
| Oak Lawn, Illinois, United States, 60453-2699 | |
| United States, Indiana | |
| Michiana Hematology-Oncology, PC - Elkhart | |
| Elkhart, Indiana, United States, 46514 | |
| Elkhart General Hospital | |
| Elkhart, Indiana, United States, 46515 | |
| Elkhart Clinic, LLC | |
| Elkhart, Indiana, United States, 46514-2098 | |
| Howard Community Hospital | |
| Kokomo, Indiana, United States, 46904 | |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | |
| La Porte, Indiana, United States, 46350 | |
| Saint Joseph Regional Medical Center | |
| Mishawaka, Indiana, United States, 46545-1470 | |
| Michiana Hematology-Oncology, PC - South Bend | |
| Mishawaka, Indiana, United States, 46545-1470 | |
| Michiana Hematology Oncology PC - Plymouth | |
| Plymouth, Indiana, United States, 46563 | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Memorial Hospital of South Bend | |
| South Bend, Indiana, United States, 46601 | |
| Michiana Hematology Oncology PC - La Porte | |
| Westville, Indiana, United States, 46391 | |
| United States, Iowa | |
| Mercy Cancer Center - West Lakes | |
| Clive, Iowa, United States, 50325 | |
| Medical Oncology and Hematology Associates - West Des Moines | |
| Clive, Iowa, United States, 50325 | |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | |
| Des Moines, Iowa, United States, 50314 | |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | |
| Des Moines, Iowa, United States, 50316 | |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | |
| Des Moines, Iowa, United States, 50309 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | |
| Des Moines, Iowa, United States, 50309 | |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | |
| Des Moines, Iowa, United States, 50314 | |
| Methodist West Hospital | |
| West Des Moines, Iowa, United States, 50266-7700 | |
| United States, Kansas | |
| Cancer Center of Kansas, PA - Chanute | |
| Chanute, Kansas, United States, 66720 | |
| Cancer Center of Kansas, PA - Dodge City | |
| Dodge City, Kansas, United States, 67801 | |
| Cancer Center of Kansas, PA - El Dorado | |
| El Dorado, Kansas, United States, 67042 | |
| Cancer Center of Kansas - Fort Scott | |
| Fort Scott, Kansas, United States, 66701 | |
| Cancer Center of Kansas-Independence | |
| Independence, Kansas, United States, 67301 | |
| Cancer Center of Kansas, PA - Kingman | |
| Kingman, Kansas, United States, 67068 | |
| Lawrence Memorial Hospital | |
| Lawrence, Kansas, United States, 66044 | |
| Cancer Center of Kansas, PA - Liberal | |
| Liberal, Kansas, United States, 67901 | |
| Cancer Center of Kansas, PA - McPherson | |
| McPherson, Kansas, United States, 67460 | |
| Cancer Center of Kansas, PA - Newton | |
| Newton, Kansas, United States, 67114 | |
| Cancer Center of Kansas, PA - Parsons | |
| Parsons, Kansas, United States, 67357 | |
| Cancer Center of Kansas, PA - Pratt | |
| Pratt, Kansas, United States, 67124 | |
| Cancer Center of Kansas, PA - Salina | |
| Salina, Kansas, United States, 67401 | |
| Cancer Center of Kansas, PA - Wellington | |
| Wellington, Kansas, United States, 67152 | |
| Cancer Center of Kansas, PA - Medical Arts Tower | |
| Wichita, Kansas, United States, 67208 | |
| Associates in Womens Health, PA - North Review | |
| Wichita, Kansas, United States, 67208 | |
| Cancer Center of Kansas, PA - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, PA - Winfield | |
| Winfield, Kansas, United States, 67156 | |
| United States, Kentucky | |
| Louisville Oncology at Norton Cancer Institute - Louisville | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Massachusetts | |
| Baystate Regional Cancer Program at D'Amour Center for Cancer Care | |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Michigan | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| Saint Joseph Mercy Cancer Center | |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| Battle Creek Health System Cancer Care Center | |
| Battle Creek, Michigan, United States, 49017 | |
| Mecosta County Medical Center | |
| Big Rapids, Michigan, United States, 49307 | |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | |
| Dearborn, Michigan, United States, 48123-2500 | |
| Genesys Hurley Cancer Institute | |
| Flint, Michigan, United States, 48503 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| Butterworth Hospital at Spectrum Health | |
| Grand Rapids, Michigan, United States, 49503 | |
| Lacks Cancer Center at Saint Mary's Health Care | |
| Grand Rapids, Michigan, United States, 49503 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| Foote Memorial Hospital | |
| Jackson, Michigan, United States, 49201 | |
| Borgess Medical Center | |
| Kalamazoo, Michigan, United States, 49001 | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| Sparrow Regional Cancer Center | |
| Lansing, Michigan, United States, 48912-1811 | |
| St. Mary Mercy Hospital | |
| Livonia, Michigan, United States, 48154 | |
| Mercy General Health Partners | |
| Muskegon, Michigan, United States, 49443 | |
| St. Joseph Mercy Oakland | |
| Pontiac, Michigan, United States, 48341-2985 | |
| Mercy Regional Cancer Center at Mercy Hospital | |
| Port Huron, Michigan, United States, 48060 | |
| Seton Cancer Institute at Saint Mary's - Saginaw | |
| Saginaw, Michigan, United States, 48601 | |
| Lakeside Cancer Specialists, PLLC | |
| Saint Joseph, Michigan, United States, 49085 | |
| Lakeland Regional Cancer Care Center - St. Joseph | |
| St. Joseph, Michigan, United States, 49085 | |
| Munson Medical Center | |
| Traverse City, Michigan, United States, 49684 | |
| St. John Macomb Hospital | |
| Warren, Michigan, United States, 48093 | |
| Metro Health Hospital | |
| Wyoming, Michigan, United States, 49519 | |
| United States, Minnesota | |
| Fairview Ridges Hospital | |
| Burnsville, Minnesota, United States, 55337 | |
| Mercy and Unity Cancer Center at Mercy Hospital | |
| Coon Rapids, Minnesota, United States, 55433 | |
| Fairview Southdale Hospital | |
| Edina, Minnesota, United States, 55435 | |
| Mercy and Unity Cancer Center at Unity Hospital | |
| Fridley, Minnesota, United States, 55432 | |
| Hutchinson Area Health Care | |
| Hutchinson, Minnesota, United States, 55350 | |
| Minnesota Oncology Hematology, PA - Maplewood | |
| Maplewood, Minnesota, United States, 55109 | |
| HealthEast Cancer Care at St. John's Hospital | |
| Maplewood, Minnesota, United States, 55109 | |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55407 | |
| Hennepin County Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55415 | |
| Humphrey Cancer Center at North Memorial Outpatient Center | |
| Robbinsdale, Minnesota, United States, 55422-2900 | |
| Park Nicollet Cancer Center | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| United Hospital | |
| Saint Paul, Minnesota, United States, 55102 | |
| St. Francis Cancer Center at St. Francis Medical Center | |
| Shakopee, Minnesota, United States, 55379 | |
| Regions Hospital Cancer Care Center | |
| St. Paul, Minnesota, United States, 55101 | |
| Lakeview Hospital | |
| Stillwater, Minnesota, United States, 55082 | |
| Ridgeview Medical Center | |
| Waconia, Minnesota, United States, 55387 | |
| Willmar Cancer Center at Rice Memorial Hospital | |
| Willmar, Minnesota, United States, 56201 | |
| Minnesota Oncology Hematology, PA - Woodbury | |
| Woodbury, Minnesota, United States, 55125 | |
| United States, Mississippi | |
| St. Dominic Cancer Center | |
| Jackson, Mississippi, United States, 39216 | |
| Regional Cancer Center at Singing River Hospital | |
| Pascagoula, Mississippi, United States, 39581 | |
| United States, Missouri | |
| Phelps County Regional Medical Center | |
| Rolla, Missouri, United States, 65401 | |
| Hulston Cancer Center at Cox Medical Center South | |
| Springfield, Missouri, United States, 65807 | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65802 | |
| St. John's Regional Health Center | |
| Springfield, Missouri, United States, 65804 | |
| United States, Nevada | |
| Women's Cancer Center - La Canada | |
| Las Vegas, Nevada, United States, 89169 | |
| United States, New Jersey | |
| UMDNJ University Hospital | |
| Newark, New Jersey, United States, 07103 | |
| United States, New York | |
| SUNY Downstate Medical Center | |
| Brooklyn, New York, United States, 11203 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Stony Brook University Cancer Center | |
| Stony Brook, New York, United States, 11794-9446 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Duke Cancer Institute | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| McDowell Cancer Center at Akron General Medical Center | |
| Akron, Ohio, United States, 44307 | |
| Summa Center for Cancer Care at Akron City Hospital | |
| Akron, Ohio, United States, 44309-2090 | |
| Aultman Cancer Center at Aultman Hospital | |
| Canton, Ohio, United States, 44710-1799 | |
| Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Riverside Methodist Hospital Cancer Care | |
| Columbus, Ohio, United States, 43214-3998 | |
| Lake/University Ireland Cancer Center | |
| Mentor, Ohio, United States, 44060 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Bryn Mawr Hospital | |
| Bryn Mawr, Pennsylvania, United States, 19010 | |
| Geisinger Cancer Institute at Geisinger Health | |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Geisinger Hazleton Cancer Center | |
| Hazleton, Pennsylvania, United States, 18201 | |
| Cancer Center of Paoli Memorial Hospital | |
| Paoli, Pennsylvania, United States, 19301-1792 | |
| Geisinger Medical Group - Scenery Park | |
| State College, Pennsylvania, United States, 16801 | |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | |
| Wilkes-Barre, Pennsylvania, United States, 18711 | |
| CCOP - Main Line Health | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Lankenau Cancer Center at Lankenau Hospital | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| United States, Rhode Island | |
| Women and Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| United States, South Carolina | |
| AnMed Cancer Center | |
| Anderson, South Carolina, United States, 29621 | |
| Cancer Centers of the Carolinas - Faris Road | |
| Greenville, South Carolina, United States, 29605 | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| Cancer Centers of the Carolinas - Seneca | |
| Seneca, South Carolina, United States, 29672 | |
| Cancer Centers of the Carolinas - Spartanburg | |
| Spartanburg, South Carolina, United States, 29307 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, South Dakota | |
| Sanford Cancer Center at Sanford USD Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Texas | |
| Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Virginia | |
| University of Virginia Cancer Center | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Wisconsin | |
| St. Mary's Hospital Medical Center - Green Bay | |
| Green Bay, Wisconsin, United States, 54303 | |
| Green Bay Oncology, Limited at St. Mary's Hospital | |
| Green Bay, Wisconsin, United States, 54303 | |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54301-3526 | |
| St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Holy Family Memorial Medical Center Cancer Care Center | |
| Manitowoc, Wisconsin, United States, 54221-1450 | |
| Bay Area Cancer Care Center at Bay Area Medical Center | |
| Marinette, Wisconsin, United States, 54143 | |
| D.N. Greenwald Center | |
| Mukwonago, Wisconsin, United States, 53149 | |
| Regional Cancer Center at Oconomowoc Memorial Hospital | |
| Oconomowoc, Wisconsin, United States, 53066 | |
| Green Bay Oncology, Limited - Sturgeon Bay | |
| Sturgeon Bay, Wisconsin, United States, 54235 | |
| Door County Cancer Center at Door County Memorial Hospital | |
| Sturgeon Bay, Wisconsin, United States, 54235-1495 | |
| Waukesha Memorial Hospital Regional Cancer Center | |
| Waukesha, Wisconsin, United States, 53188 | |
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
| Study Chair: | Sandra E. Brooks, MD | Norton Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01098630 History of Changes |
| Other Study ID Numbers: | CDR0000668836, GOG-0247 |
| Study First Received: | April 2, 2010 |
| Last Updated: | January 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent cervical cancer stage IA cervical cancer stage IB cervical cancer stage IIA cervical cancer stage IIB cervical cancer stage III cervical cancer stage IVA cervical cancer stage IVB cervical cancer recurrent endometrial carcinoma |
stage I endometrial carcinoma stage II endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma recurrent uterine sarcoma stage I uterine sarcoma stage II uterine sarcoma stage III uterine sarcoma stage IV uterine sarcoma |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Uterine Cervical Neoplasms Adenoma Sarcoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Diseases Genital Diseases, Female Uterine Cervical Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue |
ClinicalTrials.gov processed this record on May 21, 2013