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
- Conditions
- Stage I Uterine SarcomaStage IB Cervical CancerStage II Uterine Corpus CancerStage II Uterine SarcomaStage III Uterine Corpus CancerStage IVA Cervical CancerStage I Uterine Corpus CancerStage III Cervical CancerStage IVB Cervical CancerRecurrent Uterine Corpus Carcinoma
- Interventions
- Other: Medical Chart ReviewOther: Questionnaire Administration
- Registration Number
- NCT01098630
- Lead Sponsor
- Gynecologic Oncology Group
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 778
-
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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group I (limited participation) Questionnaire Administration 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 I (limited participation) Medical Chart Review 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.
- Primary Outcome Measures
Name Time Method Predictive value of modifiable patient, physician, or clinical trial specific factors on enrollment or non-enrollment onto a treatment clinical trial 7 months 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 7 months A logistic regression model analysis will be used.
- Secondary Outcome Measures
Name Time Method Patient/physician demographics 7 months 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 status 7 months Will be analyzed using categorical variable modeling methods. Logistic response functions will be used.
Trial Locations
- Locations (167)
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
🇺🇸Burbank, California, United States
Michiana Hematology Oncology PC-Elkhart
🇺🇸Elkhart, Indiana, United States
Geisinger Wyoming Valley/Henry Cancer Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
John Muir Medical Center-Concord Campus
🇺🇸Concord, California, United States
University of Arizona Cancer Center-North Campus
🇺🇸Tucson, Arizona, United States
Roy and Patricia Disney Family Cancer Center
🇺🇸Burbank, California, United States
John Muir Medical Center-Walnut Creek
🇺🇸Walnut Creek, California, United States
Elkhart Clinic
🇺🇸Elkhart, Indiana, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Community Howard Regional Health
🇺🇸Kokomo, Indiana, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, 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
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Michiana Hematology Oncology PC-Plymouth
🇺🇸Plymouth, Indiana, United States
Michiana Hematology Oncology PC-South Bend
🇺🇸South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium
🇺🇸South Bend, Indiana, United States
Mercy Cancer Center-West Lakes
🇺🇸Clive, Iowa, United States
Michiana Hematology Oncology PC-Westville
🇺🇸Westville, Indiana, United States
Medical Oncology and Hematology Associates-West Des Moines
🇺🇸Clive, Iowa, United States
Methodist West Hospital
🇺🇸West Des Moines, Iowa, United States
Mercy Medical Center-West Lakes
🇺🇸West Des Moines, Iowa, United States
Cancer Center of Kansas - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas-Liberal
🇺🇸Liberal, Kansas, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
Cancer Center of Kansas - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
🇺🇸Winfield, Kansas, United States
Bronson Battle Creek
🇺🇸Battle Creek, Michigan, United States
Saint Joseph Mercy Port Huron
🇺🇸Port Huron, Michigan, United States
Saint Mary's of Michigan
🇺🇸Saginaw, Michigan, United States
Lakeview Hospital
🇺🇸Stillwater, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium
🇺🇸Saint Louis Park, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
Saint Dominic-Jackson Memorial Hospital
🇺🇸Jackson, Mississippi, United States
Minnesota Oncology and Hematology PA-Woodbury
🇺🇸Woodbury, Minnesota, United States
Phelps County Regional Medical Center
🇺🇸Rolla, Missouri, United States
Cancer Research for the Ozarks NCORP
🇺🇸Springfield, Missouri, United States
CoxHealth South Hospital
🇺🇸Springfield, Missouri, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
State University of New York Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, 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
Lake University Ireland Cancer Center
🇺🇸Mentor, Ohio, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
🇺🇸Tulsa, Oklahoma, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
🇺🇸Hazleton, Pennsylvania, United States
Gynecologic Oncology Group
🇺🇸Philadelphia, Pennsylvania, United States
Geisinger Medical Group
🇺🇸State College, Pennsylvania, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
Women and Infants Hospital
🇺🇸Providence, Rhode Island, United States
Main Line Health NCORP
🇺🇸Wynnewood, Pennsylvania, United States
Green Bay Oncology Limited at Saint Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
Scott and White Memorial Hospital
🇺🇸Temple, Texas, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
Green Bay Oncology - Oconto Falls
🇺🇸Oconto Falls, Wisconsin, United States
Door County Cancer Center
🇺🇸Sturgeon Bay, Wisconsin, United States
Waukesha Memorial Hospital
🇺🇸Waukesha, Wisconsin, United States
The Methodist Hospital System
🇺🇸Houston, Texas, United States
Smilow Cancer Hospital Care Center at Saint Francis
🇺🇸Hartford, Connecticut, United States
The Hospital of Central Connecticut
🇺🇸New Britain, Connecticut, United States
Saint Alphonsus Cancer Care Center-Boise
🇺🇸Boise, Idaho, United States
Spectrum Health Big Rapids Hospital
🇺🇸Big Rapids, Michigan, United States
Beaumont Hospital-Dearborn
🇺🇸Dearborn, 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
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Mercy Hospital Springfield
🇺🇸Springfield, Missouri, 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
Lakeland Hospital
🇺🇸Saint Joseph, Michigan, United States
Marie Yeager Cancer Center
🇺🇸Saint Joseph, Michigan, United States
Saint John Macomb-Oakland Hospital
🇺🇸Warren, Michigan, United States
Metro Health Hospital
🇺🇸Wyoming, Michigan, United States
Singing River Hospital
🇺🇸Pascagoula, Mississippi, United States
Women's Cancer Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Rutgers New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, 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
Spartanburg Medical Center
🇺🇸Spartanburg, South Carolina, United States
Greenville Health System Cancer Institute-Seneca
🇺🇸Seneca, 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
Green Bay Oncology at Saint Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Sanford USD Medical Center - Sioux Falls
🇺🇸Sioux Falls, South Dakota, United States
Saint Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
Holy Family Memorial Hospital
🇺🇸Manitowoc, Wisconsin, United States
D N Greenwald Center
🇺🇸Mukwonago, Wisconsin, United States
Oconomowoc Memorial Hospital-ProHealth Care Inc
🇺🇸Oconomowoc, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay
🇺🇸Sturgeon Bay, Wisconsin, United States
University of California San Diego
🇺🇸San Diego, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Fairview-Southdale Hospital
🇺🇸Edina, Minnesota, 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 - Fort Scott
🇺🇸Fort Scott, Kansas, United States
Cancer Center of Kansas-Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas - Pratt
🇺🇸Pratt, Kansas, United States
Saint John's Hospital - Healtheast
🇺🇸Maplewood, Minnesota, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Cancer Center of Kansas - McPherson
🇺🇸McPherson, Kansas, United States
Associates In Womens Health
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas - Wellington
🇺🇸Wellington, Kansas, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Wichita NCI Community Oncology Research Program
🇺🇸Wichita, Kansas, United States
North Memorial Medical Health Center
🇺🇸Robbinsdale, Minnesota, United States
Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Park Nicollet Clinic - Saint Louis Park
🇺🇸Saint Louis Park, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
🇺🇸Maplewood, Minnesota, United States
Hospital District Sixth of Harper County
🇺🇸Anthony, Kansas, United States
Cancer Center of Kansas - Parsons
🇺🇸Parsons, Kansas, United States
Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Rice Memorial Hospital
🇺🇸Willmar, Minnesota, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Gynecologic Oncology Group of Arizona
🇺🇸Phoenix, Arizona, United States
Saint John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, 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
Michigan Cancer Research Consortium NCORP
🇺🇸Ann Arbor, Michigan, United States
Saint Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
🇺🇸Winston-Salem, North Carolina, United States
Saint Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Norton Hospital Pavilion and Medical Campus
🇺🇸Louisville, Kentucky, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, 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
UNC Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Allegiance Health
🇺🇸Jackson, Michigan, United States
Unity Hospital
🇺🇸Fridley, Minnesota, United States
Saint Francis Regional Medical Center
🇺🇸Shakopee, Minnesota, United States