NCT01098630

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
778

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Geographic Reach
1 country

167 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2018

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

April 2, 2010

Last Update Submit

April 11, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Enrollment status

    7 months

  • Patient/physician demographics

    7 months

Study Arms (2)

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.

Other: Medical Chart ReviewOther: Questionnaire Administration

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.

Interventions

Patients' medical record information is collected and staff complete the treatment review form

Also known as: Chart Review
Group I (limited participation)

Ancillary studies

Group I (limited participation)

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients With Primary or Recurrent Uterine, Endometrial, or Cervical Cancer

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (167)

Gynecologic Oncology Group of Arizona

Phoenix, Arizona, 85012, United States

Location

University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States

Location

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, 91505, United States

Location

Roy and Patricia Disney Family Cancer Center

Burbank, California, 91505, United States

Location

John Muir Medical Center-Concord Campus

Concord, California, 94520, United States

Location

University of California San Diego

San Diego, California, 92103, United States

Location

John Muir Medical Center-Walnut Creek

Walnut Creek, California, 94598, United States

Location

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

Florida Hospital Orlando

Orlando, Florida, 32803, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453-2699, United States

Location

Elkhart Clinic

Elkhart, Indiana, 46514-2098, United States

Location

Michiana Hematology Oncology PC-Elkhart

Elkhart, Indiana, 46514, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Community Howard Regional Health

Kokomo, Indiana, 46904, United States

Location

IU Health La Porte Hospital

La Porte, Indiana, 46350, United States

Location

Michiana Hematology Oncology PC-Mishawaka

Mishawaka, Indiana, 46545, United States

Location

Saint Joseph Regional Medical Center-Mishawaka

Mishawaka, Indiana, 46545, United States

Location

Michiana Hematology Oncology PC-Plymouth

Plymouth, Indiana, 46563, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Michiana Hematology Oncology PC-South Bend

South Bend, Indiana, 46601, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46628, United States

Location

Michiana Hematology Oncology PC-Westville

Westville, Indiana, 46391, United States

Location

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, 50325, United States

Location

Mercy Cancer Center-West Lakes

Clive, Iowa, 50325, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Iowa-Wide Oncology Research Coalition NCORP

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates-Laurel

Des Moines, Iowa, 50314, United States

Location

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

Iowa Lutheran Hospital

Des Moines, Iowa, 50316, United States

Location

Methodist West Hospital

West Des Moines, Iowa, 50266-7700, United States

Location

Mercy Medical Center-West Lakes

West Des Moines, Iowa, 50266, United States

Location

Hospital District Sixth of Harper County

Anthony, Kansas, 67003, United States

Location

Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, 66701, United States

Location

Cancer Center of Kansas-Independence

Independence, Kansas, 67301, United States

Location

Cancer Center of Kansas-Kingman

Kingman, Kansas, 67068, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

Cancer Center of Kansas-Liberal

Liberal, Kansas, 67905, United States

Location

Cancer Center of Kansas - McPherson

McPherson, Kansas, 67460, United States

Location

Cancer Center of Kansas - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas - Salina

Salina, Kansas, 67401, United States

Location

Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152, United States

Location

Associates In Womens Health

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Wichita NCI Community Oncology Research Program

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156, United States

Location

Norton Hospital Pavilion and Medical Campus

Louisville, Kentucky, 40202, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106-0995, United States

Location

Michigan Cancer Research Consortium NCORP

Ann Arbor, Michigan, 48106, United States

Location

Bronson Battle Creek

Battle Creek, Michigan, 49017, United States

Location

Spectrum Health Big Rapids Hospital

Big Rapids, Michigan, 49307, United States

Location

Beaumont Hospital-Dearborn

Dearborn, Michigan, 48124, United States

Location

Saint John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Green Bay Oncology - Escanaba

Escanaba, Michigan, 49829, United States

Location

Hurley Medical Center

Flint, Michigan, 48502, United States

Location

Genesys Regional Medical Center-West Flint Campus

Flint, Michigan, 48532, United States

Location

Cancer Research Consortium of West Michigan NCORP

Grand Rapids, Michigan, 49503, United States

Location

Mercy Health Saint Mary's

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

Green Bay Oncology - Iron Mountain

Iron Mountain, Michigan, 49801, United States

Location

Allegiance Health

Jackson, Michigan, 49201, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, 49001, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Sparrow Hospital

Lansing, Michigan, 48912, United States

Location

Saint Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

Mercy Health Mercy Campus

Muskegon, Michigan, 49444, United States

Location

Michiana Hematology Oncology PC-Niles

Niles, Michigan, 49120, United States

Location

Saint Joseph Mercy Oakland

Pontiac, Michigan, 48341, United States

Location

Saint Joseph Mercy Port Huron

Port Huron, Michigan, 48060, United States

Location

Saint Mary's of Michigan

Saginaw, Michigan, 48601, United States

Location

Lakeland Hospital

Saint Joseph, Michigan, 49085, United States

Location

Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Saint John Macomb-Oakland Hospital

Warren, Michigan, 48093, United States

Location

Metro Health Hospital

Wyoming, Michigan, 49519, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Fairview-Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Hutchinson Area Health Care

Hutchinson, Minnesota, 55350, United States

Location

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109, United States

Location

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109, United States

Location

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422, United States

Location

Metro Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Saint Francis Regional Medical Center

Shakopee, Minnesota, 55379, United States

Location

Lakeview Hospital

Stillwater, Minnesota, 55082, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Rice Memorial Hospital

Willmar, Minnesota, 56201, United States

Location

Minnesota Oncology and Hematology PA-Woodbury

Woodbury, Minnesota, 55125, United States

Location

Saint Dominic-Jackson Memorial Hospital

Jackson, Mississippi, 39216, United States

Location

Singing River Hospital

Pascagoula, Mississippi, 39581, United States

Location

Phelps County Regional Medical Center

Rolla, Missouri, 65401, United States

Location

Cancer Research for the Ozarks NCORP

Springfield, Missouri, 65804, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89169, United States

Location

Rutgers New Jersey Medical School

Newark, New Jersey, 07101, United States

Location

State University of New York Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Southeast Clinical Oncology Research (SCOR) Consortium NCORP

Winston-Salem, North Carolina, 27104, United States

Location

Summa Akron City Hospital/Cooper Cancer Center

Akron, Ohio, 44304, United States

Location

Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Aultman Health Foundation

Canton, Ohio, 44710, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Lake University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa, Oklahoma, 74146, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Geisinger Medical Center-Cancer Center Hazleton

Hazleton, Pennsylvania, 18201, United States

Location

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301, United States

Location

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

Geisinger Medical Group

State College, Pennsylvania, 16801, United States

Location

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Main Line Health NCORP

Wynnewood, Pennsylvania, 19096, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

AnMed Health Cancer Center

Anderson, South Carolina, 29621, United States

Location

AnMed Health Hospital

Anderson, South Carolina, 29621, United States

Location

Greenville Health System Cancer Institute-Faris

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute-Eastside

Greenville, South Carolina, 29615, United States

Location

Greenville Health System Cancer Institute-Seneca

Seneca, South Carolina, 29672, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Greenville Health System Cancer Institute-Spartanburg

Spartanburg, South Carolina, 29307, United States

Location

Sanford Cancer Center-Oncology Clinic

Sioux Falls, South Dakota, 57104, United States

Location

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

Location

The Methodist Hospital System

Houston, Texas, 77030, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Green Bay Oncology at Saint Vincent Hospital

Green Bay, Wisconsin, 54301-3526, United States

Location

Saint Vincent Hospital

Green Bay, Wisconsin, 54301, United States

Location

Green Bay Oncology Limited at Saint Mary's Hospital

Green Bay, Wisconsin, 54303, United States

Location

Saint Mary's Hospital

Green Bay, Wisconsin, 54303, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Holy Family Memorial Hospital

Manitowoc, Wisconsin, 54221, United States

Location

Bay Area Medical Center

Marinette, Wisconsin, 54143, United States

Location

D N Greenwald Center

Mukwonago, Wisconsin, 53149, United States

Location

Oconomowoc Memorial Hospital-ProHealth Care Inc

Oconomowoc, Wisconsin, 53066, United States

Location

Green Bay Oncology - Oconto Falls

Oconto Falls, Wisconsin, 54154, United States

Location

Door County Cancer Center

Sturgeon Bay, Wisconsin, 54235-1495, United States

Location

Green Bay Oncology - Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235, United States

Location

Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Sandra Brooks

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2010

First Posted

April 5, 2010

Study Start

July 1, 2010

Primary Completion

May 1, 2012

Study Completion

January 27, 2018

Last Updated

April 12, 2018

Record last verified: 2018-04

Locations