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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:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01098630
First received: April 2, 2010
Last updated: August 8, 2014
Last verified: August 2014
  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. 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.


Condition Intervention
Recurrent Cervical Cancer
Recurrent Endometrial Carcinoma
Recurrent Uterine Sarcoma
Stage I Endometrial Carcinoma
Stage I Uterine Sarcoma
Stage IA Cervical Cancer
Stage IB Cervical Cancer
Stage II Endometrial Carcinoma
Stage II Uterine Sarcoma
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage III Cervical Cancer
Stage III Endometrial Carcinoma
Stage III Uterine Sarcoma
Stage IV Endometrial Carcinoma
Stage IV Uterine Sarcoma
Stage IVA Cervical Cancer
Stage IVB Cervical Cancer
Other: medical chart review
Other: questionnaire administration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 Gynecologic Oncology Group:

Primary Outcome Measures:
  • Predictive value of modifiable patient, physician, or clinical trial specific factors on enrollment or non-enrollment onto a treatment clinical trial [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Two-sided Mann-Whitney U-tests will be performed.

  • Predictive value of the Functional Comorbidity Index on whether a patient is enrolled in a clinical trial [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    A logistic regression model analysis will be used.


Secondary Outcome Measures:
  • Enrollment status [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Will be analyzed using categorical variable modeling methods. Logistic response functions will be used.

  • Patient/physician demographics [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 781
Study Start Date: July 2010
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 review
Patients' medical record information is collected and staff complete the treatment review form
Other Name: chart review
Other: 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.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women With Primary Or Recurrent Invasive Cancer Of The Uterine Corpus Or Uterine Cervix, All Stages

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098630

  Hide Study Locations
Locations
United States, Arizona
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, United States, 85012
Arizona Cancer Center at University Medical Center North
Tucson, Arizona, United States, 85719
United States, California
Roy and Patricia Disney Family Cancer Center
Burbank, California, United States, 91505
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
John Muir Medical Center-Concord Campus
Concord, California, United States, 94520
University of California San Diego
San Diego, California, United States, 92103
John Muir Medical Center
Walnut Creek, California, United States, 94598
United States, Connecticut
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
United States, Hawaii
Hawaii Minority Based CCOP
Honolulu, Hawaii, United States, 96813
University of Hawaii
Honolulu, Hawaii, United States, 96813
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
United States, Illinois
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453-2699
United States, Indiana
Elkhart Clinic
Elkhart, Indiana, United States, 46514-2098
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States, 46514
Community Howard Regional Health
Kokomo, Indiana, United States, 46904
IU Health La Porte Hospital
La Porte, Indiana, United States, 46350
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States, 46563
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States, 46601
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46628
Michiana Hematology Oncology-PC Westville
Westville, Indiana, United States, 46391
United States, Iowa
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States, 50266
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
United States, Kansas
Hospital District Sixth of Harper County
Anthony, Kansas, United States, 67003
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - 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-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita CCOP
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
Norton Health Care Pavilion - Downtown
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Michigan
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States, 49307
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States, 49431
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Hurley Medical Center
Flint, Michigan, United States, 48502
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Allegiance Health
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
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Health Mercy Campus
Muskegon, Michigan, United States, 49444
Michiana Hematology Oncology PC-Niles
Niles, Michigan, United States, 49120
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Lakeland Hospital
St. Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
Saint John Macomb-Oakland 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 Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
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
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
Saint Dominic-Jackson Memorial Hospital
Jackson, Mississippi, United States, 39216
Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Phelps County Regional Medical Center
Rolla, Missouri, United States, 65401
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States, 65804
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Jersey
UMDNJ - New Jersey Medical School
Newark, New Jersey, United States, 07103
United States, New York
State University of New York Downstate Medical Center
Brooklyn, New York, United States, 11203
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Aultman Health Foundation
Canton, Ohio, United States, 44710
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States, 18201
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Mainline Health CCOP
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
AnMed Health Hospital
Anderson, South Carolina, United States, 29621
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute/Greenville CCOP
Greenville, South Carolina, United States, 29615
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Upstate Carolina CCOP
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Texas
Methodist Hospital
Houston, Texas, United States, 77030
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
D N Greenwald Center
Mukwonago, Wisconsin, United States, 53149
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc, Wisconsin, United States, 53066-3896
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Door County Cancer Center
Sturgeon Bay, Wisconsin, United States, 54235-1495
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Waukesha Memorial Hospital - ProHealth Care
Waukesha, Wisconsin, United States, 53188
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Sandra Brooks Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01098630     History of Changes
Other Study ID Numbers: GOG-0247, NCI-2011-02033, CDR0000668836, GOG-0247, GOG-0247, GOG-0247, U10CA101165
Study First Received: April 2, 2010
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Endometrial Neoplasms
Sarcoma
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 19, 2014