Comprehensive Patient Questionnaires in Predicting Complications in Older Patients With Gynecologic Cancer Undergoing Surgery

November 23, 2021 updated by: NRG Oncology

Pre-operative Assessment and Post-Operative Outcomes of Elderly Women With Gynecologic Cancers

This research trial studies comprehensive patient questionnaires in predicting complications in older patients with gynecologic cancer undergoing surgery. Comprehensive patient questionnaires completed before surgery may help identify complications, such as the need for assistance in taking medications, decreased mobility, decreased social activity, and falls, and may improve outcomes for older patients with gynecologic cancer.

Study Overview

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether the preoperative geriatric assessment (GA)-gynecology (GYN) score will be associated with major post-operative complications in elderly patients undergoing open primary cytoreduction surgery.

SECONDARY OBJECTIVES:

I. To explore associations between individual variables of the preoperative geriatric assessment and major post-operative complications in patients undergoing open primary cytoreduction surgery.

II. To assess the association between the preoperative GA-GYN score and cytoreducibility defined by extent of residual disease in patients undergoing open primary cytoreduction surgery.

TERTIARY OBJECTIVES :

I. To evaluate whether the preoperative GA-GYN scores obtained before and after neoadjuvant chemotherapy will be associated with major postoperative complications in elderly patients undergoing open interval cytoreduction surgery.

II. To describe reasons why surgeons at centers where open cytoreduction surgery is the standard of care choose to perform interval surgery vs primary surgery, and to explore the association of the preoperative GA-GYN score with the decision to perform primary surgery or interval surgery or no surgery.

III. To collect the following specific information on how elderly women with suspected ovarian, fallopian tube, primary peritoneal carcinomas or advanced stage papillary serous uterine carcinoma are treated at centers that consider open cytoreduction surgery the standard of care: (1) the percentage of patients treated with primary open cytoreduction vs. interval open cytoreduction vs. no surgery and (2) to ascertain the extent of cytoreduction.

IV. To determine whether neoadjuvant chemotherapy will be associated with changes in the GA-GYN score to change by comparing the GA-GYN scores obtained before and after neoadjuvant chemotherapy.

V. To determine whether 30-day readmission rates after cytoreductive surgery correlate with the GA-GYN score.

OUTLINE:

At time of consent and within 14 days of surgery, patients complete a pre-operative geriatric assessment that evaluates functional status, comorbid medical conditions, psychological state, social support, and nutritional status. Post-operative complications are also collected for 6 weeks after surgery or until the date patients initiate or restart chemotherapy whichever is first.

Study Type

Observational

Enrollment (Actual)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University Department of Oncology
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham Cancer Center
    • Alaska
      • Fairbanks, Alaska, United States, 99701
        • Fairbanks Memorial Hospital
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Saint Joseph's Hospital and Medical Center
      • Tucson, Arizona, United States, 85719
        • University of Arizona Cancer Center-North Campus
    • California
      • Antioch, California, United States, 94531
        • Kaiser Permanente-Deer Valley Medical Center
      • Concord, California, United States, 94520
        • John Muir Medical Center-Concord Campus
      • Fremont, California, United States, 94538
        • Kaiser Permanente-Fremont
      • Fresno, California, United States, 93720
        • Kaiser Permanente-Fresno
      • Irvine, California, United States, 92618
        • Kaiser Permanente-Irvine
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Los Angeles, California, United States, 90095
        • UCLA / Jonsson Comprehensive Cancer Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Modesto, California, United States, 95356
        • Kaiser Permanente-Modesto
      • Oakland, California, United States, 94611
        • Kaiser Permanente-Oakland
      • Redwood City, California, United States, 94063
        • Kaiser Permanente-Redwood City
      • Richmond, California, United States, 94801
        • Kaiser Permanente-Richmond
      • Roseville, California, United States, 95661
        • Kaiser Permanente-Roseville
      • Sacramento, California, United States, 95823
        • Kaiser Permanente-South Sacramento
      • Sacramento, California, United States, 95825
        • Kaiser Permanente - Sacramento
      • San Francisco, California, United States, 94115
        • Kaiser Permanente-San Francisco
      • San Jose, California, United States, 95119
        • Kaiser Permanente-Santa Teresa-San Jose
      • San Leandro, California, United States, 94577
        • Kaiser Permanente San Leandro
      • San Rafael, California, United States, 94903
        • Kaiser Permanente-San Rafael
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Rosa, California, United States, 95403
        • Kaiser Permanente-Santa Rosa
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente-South San Francisco
      • Stockton, California, United States, 95210
        • Kaiser Permanente-Stockton
      • Sylmar, California, United States, 91342
        • Olive View-University of California Los Angeles Medical Center
      • Vacaville, California, United States, 95688
        • Kaiser Permanente Medical Center-Vacaville
      • Vallejo, California, United States, 94589
        • Kaiser Permanente-Vallejo
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente-Walnut Creek
      • Walnut Creek, California, United States, 94598
        • John Muir Medical Center-Walnut Creek
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers-Aurora
      • Aurora, Colorado, United States, 80012
        • The Medical Center of Aurora
      • Boulder, Colorado, United States, 80301
        • Boulder Community Hospital
      • Boulder, Colorado, United States, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Colorado Springs, Colorado, United States, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, United States, 80907
        • Rocky Mountain Cancer Centers-Penrose
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, United States, 80218
        • SCL Health Saint Joseph Hospital
      • Denver, Colorado, United States, 80220
        • Rose Medical Center
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers-Midtown
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Centers-Rose
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
      • Denver, Colorado, United States, 80222
        • Western States Cancer Research NCORP
      • Durango, Colorado, United States, 81301
        • Mercy Medical Center
      • Durango, Colorado, United States, 81301
        • Southwest Oncology PC
      • Englewood, Colorado, United States, 80113
        • Mountain Blue Cancer Care Center - Swedish
      • Englewood, Colorado, United States, 80113
        • Swedish Medical Center
      • Golden, Colorado, United States, 80401
        • Mountain Blue Cancer Care Center
      • Greeley, Colorado, United States, 80631
        • North Colorado Medical Center
      • Greenwood Village, Colorado, United States, 80111
        • Rocky Mountain Cancer Centers-Greenwood Village
      • Lakewood, Colorado, United States, 80228
        • Saint Anthony Hospital
      • Lakewood, Colorado, United States, 80228
        • Rocky Mountain Cancer Centers-Lakewood
      • Littleton, Colorado, United States, 80120
        • Rocky Mountain Cancer Centers-Littleton
      • Littleton, Colorado, United States, 80122
        • Littleton Adventist Hospital
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Longmont, Colorado, United States, 80501
        • Longmont United Hospital
      • Longmont, Colorado, United States, 80501
        • Rocky Mountain Cancer Centers-Longmont
      • Loveland, Colorado, United States, 80539
        • McKee Medical Center
      • Parker, Colorado, United States, 80138
        • Parker Adventist Hospital
      • Parker, Colorado, United States, 80138
        • Rocky Mountain Cancer Centers-Parker
      • Pueblo, Colorado, United States, 81004
        • Saint Mary Corwin Medical Center
      • Pueblo, Colorado, United States, 81008
        • Rocky Mountain Cancer Centers - Pueblo
      • Thornton, Colorado, United States, 80260
        • Rocky Mountain Cancer Centers-Thornton
      • Wheat Ridge, Colorado, United States, 80033
        • SCL Health Lutheran Medical Center
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • New Britain, Connecticut, United States, 06050
        • The Hospital of Central Connecticut
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida Health Science Center - Gainesville
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Health Hollis Cancer Center
      • Orlando, Florida, United States, 32806
        • Orlando Health Cancer Institute
      • Pensacola, Florida, United States, 32504
        • Sacred Heart Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Savannah, Georgia, United States, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
      • Savannah, Georgia, United States, 31404
        • Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Permanente Moanalua Medical Center
    • Idaho
      • Boise, Idaho, United States, 83712
        • Saint Luke's Cancer Institute - Boise
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Health - Coeur d'Alene
      • Fruitland, Idaho, United States, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, United States, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, United States, 83686
        • Saint Luke's Cancer Institute - Nampa
      • Post Falls, Idaho, United States, 83854
        • Kootenai Clinic Cancer Services - Post Falls
      • Sandpoint, Idaho, United States, 83864
        • Kootenai Cancer Clinic
      • Twin Falls, Idaho, United States, 83301
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Bloomington, Illinois, United States, 61701
        • Saint Joseph Medical Center
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare-Canton
      • Carbondale, Illinois, United States, 62902
        • Memorial Hospital of Carbondale
      • Carthage, Illinois, United States, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, United States, 62801
        • Centralia Oncology Clinic
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare-Eureka
      • Galesburg, Illinois, United States, 61401
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare-Macomb
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • New Lenox, Illinois, United States, 60451
        • UC Comprehensive Cancer Center at Silver Cross
      • O'Fallon, Illinois, United States, 62269
        • Cancer Care Center of O'Fallon
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Ottawa, Illinois, United States, 61350
        • Radiation Oncology of Northern Illinois
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Hospital
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Pekin, Illinois, United States, 61554
        • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
      • Peoria, Illinois, United States, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, United States, 61615
        • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare-Peru
      • Peru, Illinois, United States, 61354
        • Valley Radiation Oncology
      • Princeton, Illinois, United States, 61356
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, United States, 62781
        • Memorial Medical Center
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic
      • Springfield, Illinois, United States, 62702
        • Central Illinois Hematology Oncology Center
    • Indiana
      • Crown Point, Indiana, United States, 46307
        • Michiana Hematology Oncology PC-Crown Point
      • Elkhart, Indiana, United States, 46514
        • Michiana Hematology Oncology PC-Elkhart
      • Fort Wayne, Indiana, United States, 46805
        • Parkview Hospital Randallia
      • Fort Wayne, Indiana, United States, 46804
        • Radiation Oncology Associates PC
      • Indianapolis, Indiana, United States, 46202
        • Indiana University/Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Sidney and Lois Eskenazi Hospital
      • Mishawaka, Indiana, United States, 46545
        • Michiana Hematology Oncology PC-Mishawaka
      • Plymouth, Indiana, United States, 46563
        • Michiana Hematology Oncology PC-Plymouth
      • South Bend, Indiana, United States, 46601
        • Michiana Hematology Oncology PC-South Bend
      • Westville, Indiana, United States, 46391
        • Michiana Hematology Oncology PC-Westville
    • Iowa
      • Clive, Iowa, United States, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, United States, 50325
        • Medical Oncology and Hematology Associates-West Des Moines
      • Council Bluffs, Iowa, United States, 51503
        • Alegent Health Mercy Hospital
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50314
        • Medical Oncology and Hematology Associates-Laurel
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • West Des Moines, Iowa, United States, 50266
        • Mercy Medical Center-West Lakes
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas - El Dorado
      • Fort Scott, Kansas, United States, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, United States, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas-Kingman
      • Lawrence, Kansas, United States, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, United States, 67905
        • Cancer Center of Kansas-Liberal
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas - Newton
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas - Parsons
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, United States, 67401
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, United States, 67214
        • Ascension Via Christi Hospitals Wichita
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas - Wichita
      • Wichita, Kansas, United States, 67208
        • Associates In Womens Health
      • Wichita, Kansas, United States, 67214
        • Wichita NCI Community Oncology Research Program
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas - Winfield
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Flaget Memorial Hospital
      • Corbin, Kentucky, United States, 40701
        • Baptist Health Corbin
      • Corbin, Kentucky, United States, 40701
        • Commonwealth Cancer Center-Corbin
      • Edgewood, Kentucky, United States, 41017
        • Saint Elizabeth Medical Center South
      • Elizabethtown, Kentucky, United States, 42701
        • Baptist Health Hardin
      • Lexington, Kentucky, United States, 40504
        • Saint Joseph Radiation Oncology Resource Center
      • Lexington, Kentucky, United States, 40509
        • Saint Joseph Hospital East
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
      • Louisville, Kentucky, United States, 40202
        • Jewish Hospital
      • Louisville, Kentucky, United States, 40215
        • Saints Mary and Elizabeth Hospital
      • Louisville, Kentucky, United States, 40245
        • Jewish Hospital Medical Center Northeast
      • Madisonville, Kentucky, United States, 42431
        • Baptist Health Madisonville/Merle Mahr Cancer Center
      • Paducah, Kentucky, United States, 42003
        • Baptist Health Paducah
      • Shepherdsville, Kentucky, United States, 40165
        • Jewish Hospital Medical Center South
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Medical Center- Scarborough Campus
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, United States, 21201
        • University of Maryland/Greenebaum Cancer Center
    • Michigan
      • Battle Creek, Michigan, United States, 49017
        • Bronson Battle Creek
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Farmington Hills, Michigan, United States, 48334
        • Weisberg Cancer Treatment Center
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health at Butterworth Campus
      • Grand Rapids, Michigan, United States, 49503
        • Mercy Health Saint Mary's
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49048
        • Borgess Medical Center
      • Muskegon, Michigan, United States, 49444
        • Mercy Health Mercy Campus
      • Niles, Michigan, United States, 49120
        • Lakeland Hospital Niles
      • Reed City, Michigan, United States, 49677
        • Spectrum Health Reed City Hospital
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Medical Center Saint Joseph
      • Saint Joseph, Michigan, United States, 49085
        • Marie Yeager Cancer Center
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, United States, 55350
        • Hutchinson Area Health Care
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55454
        • Health Partners Inc
      • New Ulm, Minnesota, United States, 56073
        • New Ulm Medical Center
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
      • Saint Cloud, Minnesota, United States, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
      • Saint Cloud, Minnesota, United States, 56303
        • Saint Cloud Hospital
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, United States, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology PA-Woodbury
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Saint Dominic-Jackson Memorial Hospital
    • Missouri
      • Bonne Terre, Missouri, United States, 63628
        • Parkland Health Center-Bonne Terre
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, United States, 63703
        • Southeast Cancer Center
      • Jefferson City, Missouri, United States, 65109
        • Capital Region Southwest Campus
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
      • Sainte Genevieve, Missouri, United States, 63670
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, United States, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
      • Sullivan, Missouri, United States, 63080
        • Missouri Baptist Sullivan Hospital
      • Sunset Hills, Missouri, United States, 63127
        • Missouri Baptist Outpatient Center-Sunset Hills
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
      • Billings, Montana, United States, 59101
        • Saint Vincent Healthcare
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Hospital
      • Butte, Montana, United States, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, United States, 59405
        • Benefis Healthcare- Sletten Cancer Institute
      • Helena, Montana, United States, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
      • Missoula, Montana, United States, 59804
        • Community Medical Hospital
      • Missoula, Montana, United States, 59802
        • Saint Patrick Hospital - Community Hospital
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • CHI Health Saint Francis
      • Kearney, Nebraska, United States, 68847
        • CHI Health Good Samaritan
      • Kearney, Nebraska, United States, 68845
        • Heartland Hematology and Oncology
      • Lincoln, Nebraska, United States, 68510
        • Saint Elizabeth Regional Medical Center
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
      • Omaha, Nebraska, United States, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, United States, 68122
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, United States, 68130
        • Alegent Health Lakeside Hospital
      • Omaha, Nebraska, United States, 68131
        • Creighton University Medical Center
      • Omaha, Nebraska, United States, 68122
        • Hematology and Oncology Consultants PC
      • Papillion, Nebraska, United States, 68046
        • Midlands Community Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Women's Cancer Center of Nevada
    • New Hampshire
      • Dover, New Hampshire, United States, 03820
        • Wentworth-Douglass Hospital
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital University Medical Center
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
      • Summit, New Jersey, United States, 07902
        • Overlook Hospital
      • Voorhees, New Jersey, United States, 08043
        • MD Anderson Cancer Center at Cooper-Voorhees
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, United States, 87106
        • Southwest Gynecologic Oncology Associates Inc
    • New York
      • Albany, New York, United States, 12208
        • Women's Cancer Care Associates LLC
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center-Einstein Campus
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center - Moses Campus
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center-Weiler Hospital
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Sleepy Hollow, New York, United States, 10591
        • Memorial Sloan Kettering Sleepy Hollow
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical University
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Presbyterian Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Akron, Ohio, United States, 44307
        • Cleveland Clinic Akron General
      • Beachwood, Ohio, United States, 44122
        • UHHS-Chagrin Highlands Medical Center
      • Belpre, Ohio, United States, 45714
        • Strecker Cancer Center-Belpre
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati, Ohio, United States, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, United States, 45202
        • Oncology Hematology Care Inc-Eden Park
      • Cincinnati, Ohio, United States, 45247
        • TriHealth Cancer Institute-Westside
      • Cincinnati, Ohio, United States, 45255
        • TriHealth Cancer Institute-Anderson
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, United States, 43214
        • Columbus Oncology and Hematology Associates Inc
      • Columbus, Ohio, United States, 43228
        • Doctors Hospital
      • Columbus, Ohio, United States, 43215
        • Grant Medical Center
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health Center West
      • Delaware, Ohio, United States, 43015
        • Delaware Health Center-Grady Cancer Center
      • Delaware, Ohio, United States, 43015
        • Delaware Radiation Oncology
      • Delaware, Ohio, United States, 43015
        • Grady Memorial Hospital
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
      • Marietta, Ohio, United States, 45750
        • Marietta Memorial Hospital
      • Marion, Ohio, United States, 43302
        • OhioHealth Marion General Hospital
      • Mayfield Heights, Ohio, United States, 44124
        • UH Seidman Cancer Center at Landerbrook Health Center
      • Mentor, Ohio, United States, 44060
        • UH Seidman Cancer Center at Lake Health Mentor Campus
      • Mount Vernon, Ohio, United States, 43050
        • Knox Community Hospital
      • Newark, Ohio, United States, 43055
        • Licking Memorial Hospital
      • Newark, Ohio, United States, 43055
        • Newark Radiation Oncology
      • Portsmouth, Ohio, United States, 45662
        • Southern Ohio Medical Center
      • Springfield, Ohio, United States, 45505
        • Springfield Regional Medical Center
      • Wadsworth, Ohio, United States, 44281
        • University Hospitals Sharon Health Center
      • Westerville, Ohio, United States, 43081
        • Saint Ann's Hospital
      • Westlake, Ohio, United States, 44145
        • UHHS-Westlake Medical Center
      • Wright-Patterson Air Force Base, Ohio, United States, 45433
        • Wright-Patterson Medical Center
      • Zanesville, Ohio, United States, 43701
        • Genesis Healthcare System Cancer Care Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Jefferson Abington Hospital
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Hazleton, Pennsylvania, United States, 18201
        • Geisinger Medical Center-Cancer Center Hazleton
      • Lewisburg, Pennsylvania, United States, 17837
        • Geisinger Medical Oncology-Lewisburg
      • Paoli, Pennsylvania, United States, 19301
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania/Abramson Cancer Center
      • Pottsville, Pennsylvania, United States, 17901
        • Geisinger Cancer Services-Pottsville
      • State College, Pennsylvania, United States, 16801
        • Geisinger Medical Group
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Cancer Center
      • Boiling Springs, South Carolina, United States, 29316
        • Prisma Health Cancer Institute - Spartanburg
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Easley, South Carolina, United States, 29640
        • Prisma Health Cancer Institute - Easley
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, United States, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute - Butternut
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Greenville Memorial Hospital
      • Greenville, South Carolina, United States, 29601
        • Greenville Health System Cancer Institute-Andrews
      • Greer, South Carolina, United States, 29650
        • Prisma Health Cancer Institute - Greer
      • Seneca, South Carolina, United States, 29672
        • Prisma Health Cancer Institute - Seneca
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Memorial Hospital
      • Hixson, Tennessee, United States, 37343
        • Pulmonary Medicine Center of Chattanooga-Hixson
      • Ooltewah, Tennessee, United States, 37363
        • Memorial GYN Plus
    • Texas
      • Austin, Texas, United States, 78701
        • Dell Seton Medical Center at The University of Texas
      • Dallas, Texas, United States, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, United States, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
    • Utah
      • American Fork, Utah, United States, 84003
        • American Fork Hospital / Huntsman Intermountain Cancer Center
      • Cedar City, Utah, United States, 84720
        • Sandra L Maxwell Cancer Center
      • Logan, Utah, United States, 84321
        • Logan Regional Hospital
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
      • Ogden, Utah, United States, 84403
        • McKay-Dee Hospital Center
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center
      • Saint George, Utah, United States, 84770
        • Dixie Medical Center Regional Cancer Center
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute/University of Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists-Salt Lake City
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center
    • Washington
      • Auburn, Washington, United States, 98001
        • MultiCare Auburn Medical Center
      • Bainbridge Island, Washington, United States, 98110
        • Virginia Mason Bainbridge Island Medical Center
      • Bellevue, Washington, United States, 98004
        • Overlake Medical Center
      • Bremerton, Washington, United States, 98310
        • Harrison HealthPartners Hematology and Oncology-Bremerton
      • Bremerton, Washington, United States, 98310
        • Harrison Medical Center
      • Burien, Washington, United States, 98166
        • Highline Medical Center-Main Campus
      • Enumclaw, Washington, United States, 98022
        • Saint Elizabeth Hospital
      • Federal Way, Washington, United States, 98002
        • Virginia Mason Federal Way Medical Center
      • Federal Way, Washington, United States, 98003
        • Saint Francis Hospital
      • Gig Harbor, Washington, United States, 98332
        • Tacoma/Valley Radiation Oncology Centers-Gig Harbor
      • Gig Harbor, Washington, United States, 98335
        • MultiCare Gig Harbor Medical Park
      • Kennewick, Washington, United States, 99336
        • Northwest Cancer Clinic
      • Lakewood, Washington, United States, 98499
        • Saint Clare Hospital
      • Lynnwood, Washington, United States, 98036
        • Virginia Mason Lynnwood Medical Center
      • Poulsbo, Washington, United States, 98370
        • Harrison HealthPartners Hematology and Oncology-Poulsbo
      • Poulsbo, Washington, United States, 98370
        • Peninsula Cancer Center
      • Puyallup, Washington, United States, 98372
        • MultiCare Good Samaritan Hospital
      • Puyallup, Washington, United States, 98372
        • Tacoma/Valley Radiation Oncology Centers-Puyallup
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties PLLC
      • Tacoma, Washington, United States, 98405
        • MultiCare Tacoma General Hospital
      • Tacoma, Washington, United States, 98405
        • Tacoma/Valley Radiation Oncology Centers-Saint Joe's
      • Tacoma, Washington, United States, 97405
        • Tacoma/Valley Radiation Oncology Centers-Jackson Hall
      • Tacoma, Washington, United States, 98405
        • Franciscan Research Center-Northwest Medical Plaza
      • Tacoma, Washington, United States, 98405
        • Northwest NCI Community Oncology Research Program
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Monongalia Hospital
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Green Bay, Wisconsin, United States, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center-Marshfield
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Clinic-Minocqua Center
      • Mukwonago, Wisconsin, United States, 53149
        • ProHealth D N Greenwald Center
      • New Richmond, Wisconsin, United States, 54017
        • Cancer Center of Western Wisconsin
      • Oconomowoc, Wisconsin, United States, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Medical Center-Rice Lake
      • Stevens Point, Wisconsin, United States, 54481
        • Ascension Saint Michael's Hospital
      • Waukesha, Wisconsin, United States, 53188
        • ProHealth Waukesha Memorial Hospital
      • Wausau, Wisconsin, United States, 54401
        • Marshfield Clinic-Wausau Center
      • Weston, Wisconsin, United States, 54476
        • Marshfield Medical Center - Weston
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Cheyenne Regional Medical Center-West
      • Cody, Wyoming, United States, 82414
        • Big Horn Basin Cancer Center
      • Cody, Wyoming, United States, 82414
        • Billings Clinic-Cody
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Elderly women with suspected ovarian, fallopian tube, primary peritoneal or advanced stage papillary serous uterine carcinoma undergoing open cytoreductive surgery

Description

Inclusion Criteria:

  • Patients with suspected ovarian, fallopian tube, primary peritoneal carcinomas or advanced stage papillary serous uterine carcinoma irrespective of performance status; this clinical determination is made by the treating physician
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients who can understand sufficiently to be able to respond to questions posed by the study instruments
  • Patients and/or caregiver (durable power of attorney) can give consent and caregiver can assist with the responses to questionnaire

    • NOTE: it is the intent of this trial that all patients 70 years or older presenting to the participating physician/center be offered enrollment onto this study; eligible patients may enroll and subsequently receive neoadjuvant chemotherapy followed by interval surgery, primary cytoreductive surgery or no surgery at all
  • Post-operative pathology will not exclude patients from this study

Exclusion Criteria:

  • Patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up
  • Patients who would have planned surgery performed by the minimally invasive technique; institutions which perform cytoreductive surgery via the minimally invasive technique should not participate in this study; the minimally invasive surgery (MIS) technique is also not considered standard technique for primary cytoreductive surgery for advanced stage ovarian, fallopian tube or peritoneal cancers
  • Patients who receive chemotherapy treatment (for a gynecologic malignancy) prior to consideration of enrollment into this trial and taking the geriatric assessment will be excluded
  • Patients who have a known pre-operative primary uterine cancer, confirmed by endometrial biopsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (geriatric assessment)
At time of consent and within 14 days of surgery, patients complete a pre-operative geriatric assessment that evaluates functional status, comorbid medical conditions, psychological state, social support, and nutritional status. Post-operative complications are also collected for 6 weeks after surgery or until the date patients initiate or restart chemotherapy whichever is first.
Ancillary studies
Complete pre-operative geriatric assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of major post-operative complications outlined in The American College of Surgeons' National Surgical Quality Improvement Program
Time Frame: Up to 6 weeks after surgery
Up to 6 weeks after surgery
GA-GYN score, defined as the summation of the risk score for each risk factor derived from the predictive model including 5 risk factors from the GA and 3 other risk factors
Time Frame: Up to 14 days before surgery
Geriatric assessment variables are used in the predictive model; the risk factors will be used to derive the total score.
Up to 14 days before surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent of residual disease in patients undergoing open primary cytoreduction surgery
Time Frame: 6 weeks after surgery
The association between the preoperative GA-GYN score and cytoreducibility defined by extent of residual disease in patients undergoing open primary cytoreduction surgery will be assessed. Cytoreducibility is defined as complete cytoreduction (maximum dimension of residual disease =< 0.1 cm), optimal cytoreduction (maximum dimension of residual disease greater than 0.1 cm but less than or equal to 1.0 cm), or suboptimal cytoreduction (maximum dimension of residual disease greater than 1.0 cm) according to extent of residual disease.
6 weeks after surgery
Functional status, as measured by Instrumental Activities of Daily Living (IADL)
Time Frame: Up to 14 days before surgery
The IADL subscale consists of 7 questions rated on a 3-point Likert scale measuring the degree to which an activity can be performed independently.
Up to 14 days before surgery
Functional status, as measured by Activities of Daily Living (ADL)
Time Frame: Up to 14 days before surgery
The ALD uses a subscale of the Medical Outcomes Study physical health with 10 questions rated on a 3-point scale.
Up to 14 days before surgery
Patient's overall functioning, as measured by the physician rated performance rating scale
Time Frame: Up to 14 days before surgery
Up to 14 days before surgery
Patient's overall functioning, as measured by the self-reported performance rating scale
Time Frame: Up to 14 days before surgery
Up to 14 days before surgery
Number of falls in last 6 months
Time Frame: Up to 14 days before surgery
Up to 14 days before surgery
Comorbidity, as measured by the Older American Resources and Services (OARS) Physical Health section
Time Frame: Up to 14 days before surgery
The OARS Physical Health Section is a comorbidity scale that contains a list of current illnesses and conditions an individual might have, and the degree to which they impair daily activities, rated on a 3-point scale of " not at all" to " a great deal."
Up to 14 days before surgery
Psychological status, as measured by the Mental Health Inventory (MHI) that is based upon the General Well-Being Scale
Time Frame: Up to 14 days before surgery
The full length MHI consists of 38 items grouped into the following five subscales and three global scores: anxiety, depression, general positive affect, emotional ties, and loss of behavioral emotional control, Psychological Distress (negative affect), Psychological Well-Being (positive affect), and the MHI total score a 17 item version of the MHI will be used, which will yield three global scores of Psychological Distress, Psychological Well-Being and MHI total score, as in the original 38 item MHI.
Up to 14 days before surgery
Social functioning, as measured by the Medical Outcomes Study (MOS) Social Activity Limitations Measure
Time Frame: Up to 14 days before surgery
The four-item subscale identifies the extent to which physical or emotional problems interfere with an individual's social activities. All items are rated on a 5-point Likert scale, with response categories varying in each item. The mean of the total score is transformed to a scale of 0-100, with a higher number indicating greater support.
Up to 14 days before surgery
Social support, as measured by the MOS Social Support Survey
Time Frame: Up to 14 days before surgery
Up to 14 days before surgery
Nutritional status, as measured by BMI
Time Frame: Up to 14 days before surgery
Up to 14 days before surgery
Nutritional status, as measured by percentage unintentional weight loss in last 6 months
Time Frame: Up to 14 days before surgery
Up to 14 days before surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of reasons why surgeons perform interval surgery vs primary surgery and preoperative GA-GYN score
Time Frame: 6 weeks after surgery
6 weeks after surgery
Frequency of patients treated with primary cytoreduction, interval cytoreduction, no surgery and the extent of surgery
Time Frame: 6 weeks after surgery
6 weeks after surgery
Preoperative GA-GYN scores obtained before and after neoadjuvant chemotherapy
Time Frame: Up to 14 days before surgery
Up to 14 days before surgery
30-day readmission after cytoreduction surgery
Time Frame: Up to 30 days after surgery
Will explore the correlation between pre-surgery GA-GYN score and dichotomized 30-day readmission.
Up to 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Amina Ahmed, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 10, 2015

Primary Completion (ACTUAL)

March 15, 2016

Study Completion (ACTUAL)

February 9, 2019

Study Registration Dates

First Submitted

December 9, 2014

First Submitted That Met QC Criteria

December 9, 2014

First Posted (ESTIMATE)

December 11, 2014

Study Record Updates

Last Update Posted (ACTUAL)

November 24, 2021

Last Update Submitted That Met QC Criteria

November 23, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • NRG-CC002 (OTHER: CTEP)
  • UG1CA189867 (U.S. NIH Grant/Contract)
  • U10CA101165 (U.S. NIH Grant/Contract)
  • NCI-2014-01376 (REGISTRY: CTRP (Clinical Trial Reporting Program))
  • GOG-ELD1301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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