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Recurrent Cervical CarcinomaNCT01098630

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

An observational study of Recurrent Cervical Carcinoma and Recurrent Uterine Corpus Carcinoma, run by Gynecologic Oncology Group at 167 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
What is being tested?
Medical Chart Review and Questionnaire Administration
How many people
778 participants
Where
167 sitesUnited States
Study dates
Jul 2010to 27 Jan 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients With Primary or Recurrent Uterine, Endometrial, or Cervical Cancer

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

167 sites in 1 country.

167 sites in 1 country

United States167 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • Akron General Medical Center

    Akron, Ohio, 44307

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • Hospital District Sixth of Harper County

    Anthony, Kansas, 67003

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Spectrum Health Big Rapids Hospital

    Big Rapids, Michigan, 49307

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • State University of New York Downstate Medical Center

    Brooklyn, New York, 11203

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Roy and Patricia Disney Family Cancer Center

    Burbank, California, 91505

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • John Muir Medical Center-Concord Campus

    Concord, California, 94520

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Beaumont Hospital-Dearborn

    Dearborn, Michigan, 48124

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa-Wide Oncology Research Coalition NCORP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart Clinic

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology Oncology PC-Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49829

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Cancer Research Consortium of West Michigan NCORP

    Grand Rapids, Michigan, 49503

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Greenville Health System Cancer Institute-Faris

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • The Methodist Hospital System

    Houston, Texas, 77030

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Green Bay Oncology - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Allegiance Health

    Jackson, Michigan, 49201

  • Saint Dominic-Jackson Memorial Hospital

    Jackson, Mississippi, 39216

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89169

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Norton Hospital Pavilion and Medical Campus

    Louisville, Kentucky, 40202

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin, 54221

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Cancer Center of Kansas - McPherson

    McPherson, Kansas, 67460

  • Lake University Ireland Cancer Center

    Mentor, Ohio, 44060

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Michiana Hematology Oncology PC-Mishawaka

    Mishawaka, Indiana, 46545

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545

  • D N Greenwald Center

    Mukwonago, Wisconsin, 53149

  • Mercy Health Mercy Campus

    Muskegon, Michigan, 49444

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07101

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Michiana Hematology Oncology PC-Niles

    Niles, Michigan, 49120

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453-2699

  • Oconomowoc Memorial Hospital-ProHealth Care Inc

    Oconomowoc, Wisconsin, 53066

  • Green Bay Oncology - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Florida Hospital Orlando

    Orlando, Florida, 32803

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Gynecologic Oncology Group

    Philadelphia, Pennsylvania, 19103

  • Gynecologic Oncology Group of Arizona

    Phoenix, Arizona, 85012

  • Michiana Hematology Oncology PC-Plymouth

    Plymouth, Indiana, 46563

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Saint Joseph Mercy Port Huron

    Port Huron, Michigan, 48060

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Phelps County Regional Medical Center

    Rolla, Missouri, 65401

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • Lakeland Hospital

    Saint Joseph, Michigan, 49085

  • Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • University of California San Diego

    San Diego, California, 92103

  • Greenville Health System Cancer Institute-Seneca

    Seneca, South Carolina, 29672

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Sanford Cancer Center-Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Michiana Hematology Oncology PC-South Bend

    South Bend, Indiana, 46601

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Greenville Health System Cancer Institute-Spartanburg

    Spartanburg, South Carolina, 29307

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Cancer Research for the Ozarks NCORP

    Springfield, Missouri, 65804

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Door County Cancer Center

    Sturgeon Bay, Wisconsin, 54235-1495

  • Green Bay Oncology - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • John Muir Medical Center-Walnut Creek

    Walnut Creek, California, 94598

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Methodist West Hospital

    West Des Moines, Iowa, 50266-7700

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

  • Michiana Hematology Oncology PC-Westville

    Westville, Indiana, 46391

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wichita NCI Community Oncology Research Program

    Wichita, Kansas, 67214

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Southeast Clinical Oncology Research (SCOR) Consortium NCORP

    Winston-Salem, North Carolina, 27104

  • Minnesota Oncology and Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • Main Line Health NCORP

    Wynnewood, Pennsylvania, 19096

  • Metro Health Hospital

    Wyoming, Michigan, 49519

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Medical Chart Review, Questionnaire Administration
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medical Chart ReviewOther

    Also called Chart Review

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

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT01098630
Study groupRoleWhat they receive
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.
Receives: Other: Medical Chart Review; Other: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7 months

  2. 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.

    Measured: 7 months

Secondary outcomes (2)

  1. Enrollment status

    Will be analyzed using categorical variable modeling methods. Logistic response functions will be used.

    Measured: 7 months

  2. Patient/physician demographics

    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.

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionMay 2012
  4. Study completion27 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
778 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01098630
Sponsor's protocol ID
GOG-0247
Other IDs
NCI-2011-02033, CDR0000668836, GOG-0247, GOG-0247, GOG-0247, U10CA101165
Status last verified
Apr 2018
First submitted
2 Apr 2010
Last updated
12 Apr 2018
Results posted
No

Publications

  • 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.

    PubMed 25937529

Questions about this trial

What is this clinical trial studying?

An observational study of Recurrent Cervical Carcinoma and Recurrent Uterine Corpus Carcinoma, run by Gynecologic Oncology Group at 167 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01098630, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.

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