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
NCT ID: NCT01098630
Last Updated: 2018-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
778 participants
OBSERVATIONAL
2010-07-31
2018-01-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Medical Chart Review
Patients' medical record information is collected and staff complete the treatment review form
Questionnaire Administration
Ancillary studies
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.
No interventions assigned to this group
Interventions
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Medical Chart Review
Patients' medical record information is collected and staff complete the treatment review form
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Sandra Brooks
Role: PRINCIPAL_INVESTIGATOR
Gynecologic Oncology Group
Locations
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Gynecologic Oncology Group of Arizona
Phoenix, Arizona, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Roy and Patricia Disney Family Cancer Center
Burbank, California, United States
John Muir Medical Center-Concord Campus
Concord, California, United States
University of California San Diego
San Diego, California, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Florida Hospital Orlando
Orlando, Florida, United States
Queen's Medical Center
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Elkhart Clinic
Elkhart, Indiana, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Community Howard Regional Health
Kokomo, Indiana, United States
IU Health La Porte Hospital
La Porte, Indiana, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
Methodist West Hospital
West Des Moines, Iowa, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States
Hospital District Sixth of Harper County
Anthony, Kansas, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates In Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
Wichita NCI Community Oncology Research Program
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States
Beaumont Hospital-Dearborn
Dearborn, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Mercy Health Mercy Campus
Muskegon, Michigan, United States
Michiana Hematology Oncology PC-Niles
Niles, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States
Saint Mary's of Michigan
Saginaw, Michigan, United States
Lakeland Hospital
Saint Joseph, Michigan, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview-Southdale Hospital
Edina, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States
Saint Dominic-Jackson Memorial Hospital
Jackson, Mississippi, United States
Singing River Hospital
Pascagoula, Mississippi, United States
Phelps County Regional Medical Center
Rolla, Missouri, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
State University of New York Downstate Medical Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States
Akron General Medical Center
Akron, Ohio, United States
Aultman Health Foundation
Canton, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Lake University Ireland Cancer Center
Mentor, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Main Line Health NCORP
Wynnewood, Pennsylvania, United States
Women and Infants Hospital
Providence, Rhode Island, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
AnMed Health Hospital
Anderson, South Carolina, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
The Methodist Hospital System
Houston, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital
Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States
Saint Mary's Hospital
Green Bay, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States
Bay Area Medical Center
Marinette, Wisconsin, United States
D N Greenwald Center
Mukwonago, Wisconsin, United States
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc, Wisconsin, United States
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States
Door County Cancer Center
Sturgeon Bay, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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NCI-2011-02033
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000668836
Identifier Type: -
Identifier Source: secondary_id
GOG-0247
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0247
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0247
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0247
Identifier Type: -
Identifier Source: org_study_id
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