Quality of Life and Care Needs of Patients With Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Peritoneal Cancer

March 8, 2019 updated by: Gynecologic Oncology Group

Quality of Life and Care Needs in Patients With Persistent or Recurrent Platinum-Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer

This clinical trial studies the quality of life and care needs of patients with persistent or recurrent ovarian cancer, fallopian tube cancer, or peritoneal cancer. Studying quality of life in patients with cancer may help determine the effects of gynecologic cancer and may help improve the quality of life for future cancer survivors.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the prevalence and severity of patient-reported symptoms in patients with platinum-resistant ovarian, fallopian tube, and peritoneal cancers at study entry and at three and six months post-enrollment.

SECONDARY OBJECTIVES:

I. To explore the unmet needs of these women at study entry and at three and six months post-enrollment (Exploratory) II. To explore the overall quality-of-life (QOL) of these women at study entry and at three and six months post enrollment. (Exploratory) III. To explore the relationship between patient-reported symptoms and overall QOL, current cancer therapy (yes/no), and treatment responses (if on cancer therapy). (Exploratory)

OUTLINE: This is a multicenter study.

Patients complete the Needs at the End-of-Life Screening Tool (NEST), the Functional Assessment of Cancer Therapy ? Ovarian (FACT-O), the FACIT-Fatigue Subscale (FACIT-F), the National Comprehensive Cancer Network (NCCN) FACT Ovarian Symptom Index-18 (NFOSI-18), the FACT/GOG-AD subscale for ovarian cancer-related abdominal discomfort, and the FACT/GOG-Neurotoxicity (FACT/GOG-NTX) Scale quality-of-life questionnaires at baseline and at 3 and 6 months during office or clinic visits or via telephone or mail. Patients' demographic and therapy information, such as current age, ethnicity, marital status, employment status, prior chemotherapy regimens/cancer treatment, disease status (if available), performance status, patient care information, and current cancer therapy are also collected.

After completion of study participation, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Study Type

Observational

Enrollment (Actual)

103

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

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Smilow Cancer Hospital Care Center at Saint Francis
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • New Britain, Connecticut, United States, 06050
        • The Hospital of Central Connecticut
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii Cancer Center
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center-Boise
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Hinsdale, Illinois, United States, 60521
        • Sudarshan K Sharma MD Limited-Gynecologic Oncology
      • Mount Vernon, Illinois, United States, 62864
        • Good Samaritan Regional Health Center
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Hospital
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Indiana
      • Elkhart, Indiana, United States, 46515
        • Elkhart General Hospital
      • Elkhart, Indiana, United States, 46514
        • Michiana Hematology Oncology PC-Elkhart
      • Elkhart, Indiana, United States, 46514-2098
        • Elkhart Clinic
      • Kokomo, Indiana, United States, 46904
        • Community Howard Regional Health
      • La Porte, Indiana, United States, 46350
        • IU Health La Porte Hospital
      • Mishawaka, Indiana, United States, 46545
        • Michiana Hematology Oncology PC-Mishawaka
      • Mishawaka, Indiana, United States, 46545
        • Saint Joseph Regional Medical Center-Mishawaka
      • Plymouth, Indiana, United States, 46563
        • Michiana Hematology Oncology PC-Plymouth
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, United States, 46601
        • Michiana Hematology Oncology PC-South Bend
      • South Bend, Indiana, United States, 46628
        • Northern Indiana Cancer Research Consortium
      • South Bend, Indiana, United States, 46617
        • South Bend Clinic
      • Westville, Indiana, United States, 46391
        • Michiana Hematology Oncology PC-Westville
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic PC - Ames
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50309
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines, Iowa, United States, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, United States, 50309
        • Iowa-Wide Oncology Research Coalition NCORP
      • Des Moines, Iowa, United States, 50314
        • Medical Oncology and Hematology Associates-Laurel
    • 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
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas-Kingman
      • Liberal, Kansas, United States, 67905
        • Cancer Center of Kansas-Liberal
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas - Newton
      • Overland Park, Kansas, United States, 66213
        • Saint Luke's South Hospital
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas - Parsons
      • Prairie Village, Kansas, United States, 66208
        • Kansas City NCI Community Oncology Research Program
      • 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, 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
      • Wichita, Kansas, United States, 67214
        • Via Christi Regional Medical Center
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas - Winfield
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center-Bramhall Campus
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
      • Worcester, Massachusetts, United States, 01605
        • University of Massachusetts Memorial Health Care
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • Saint Joseph Mercy Hospital
      • Ann Arbor, Michigan, United States, 48106
        • Michigan Cancer Research Consortium NCORP
      • Dearborn, Michigan, United States, 48124
        • Beaumont Hospital ? Dearborn
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48236
        • Ascension Saint John Hospital
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Regional Medical Center
      • Jackson, Michigan, United States, 49201
        • Allegiance Health
      • 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
      • Lansing, Michigan, United States, 48912
        • Sparrow Hospital
      • Livonia, Michigan, United States, 48154
        • Saint Mary Mercy Hospital
      • Pontiac, Michigan, United States, 48341
        • Saint Joseph Mercy Oakland
      • Port Huron, Michigan, United States, 48060
        • Lake Huron Medical Center
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital-Royal Oak
      • Saginaw, Michigan, United States, 48601
        • Ascension Saint Mary's Hospital
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Medical Center Saint Joseph
      • Saint Joseph, Michigan, United States, 49085
        • Marie Yeager Cancer Center
      • Warren, Michigan, United States, 48093
        • Saint John Macomb-Oakland Hospital
    • 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
      • New Ulm, Minnesota, United States, 56073
        • New Ulm Medical Center
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, United States, 55416
        • Metro Minnesota Community Oncology Research Consortium
      • 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
        • University of Mississippi Medical Center
      • Jackson, Mississippi, United States, 39216
        • Saint Dominic-Jackson Memorial Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Lee's Summit, Missouri, United States, 64086
        • Saint Luke's East - Lee's Summit
      • Rolla, Missouri, United States, 65401
        • Delbert Day Cancer Institute at PCRMC
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Springfield, Missouri, United States, 65804
        • Cancer Research for the Ozarks NCORP
      • Springfield, Missouri, United States, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Women's Cancer Center of Nevada
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • University of New Mexico Cancer Center
    • New York
      • Brooklyn, New York, United States, 11203
        • State University of New York Downstate Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Concord, North Carolina, United States, 28025
        • Atrium Health Cabarrus/LCI-Concord
    • Ohio
      • Akron, Ohio, United States, 44307
        • Cleveland Clinic Akron General
      • Akron, Ohio, United States, 44304
        • Summa Akron City Hospital/Cooper Cancer Center
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Mentor, Ohio, United States, 44060
        • UH Seidman Cancer Center at Lake Health Mentor Campus
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Hospital
      • Paoli, Pennsylvania, United States, 19301
        • Paoli Memorial Hospital
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
      • Wynnewood, Pennsylvania, United States, 19096
        • Main Line Health NCORP
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System Cancer Institute-Faris
      • Greenville, South Carolina, United States, 29615
        • Greenville Health System Cancer Institute-Eastside
      • Seneca, South Carolina, United States, 29672
        • Greenville Health System Cancer Institute-Seneca
      • Spartanburg, South Carolina, United States, 29307
        • Greenville Health System Cancer Institute-Spartanburg
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Chattanooga's Program in Women's Oncology
    • Texas
      • Houston, Texas, United States, 77030
        • Memorial Hermann Texas Medical Center
      • Temple, Texas, United States, 76508
        • Scott and White Memorial Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology Limited at Saint Mary's Hospital
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology at Saint Vincent Hospital
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics
      • Manitowoc, Wisconsin, United States, 54221
        • Holy Family Memorial Hospital
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Medical Center
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert and The Medical College of Wisconsin
      • New Richmond, Wisconsin, United States, 54017
        • Cancer Center of Western Wisconsin

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Description

Inclusion Criteria:

  • Patients with persistent or recurrent epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer

    • Platinum-resistant (less than 6 months from date of last platinum therapy to date of first evidence of recurrent or persistent disease) disease as measured by any of the following:

      • Imaging
      • Physical exam
      • CA-125 that is twice the upper limit of normal on two occasions with at least one week apart
    • No patients who have platinum resistant or refractory disease after more than 6 months since prior therapy

  • Criteria for patients on cancer therapy (e.g., chemotherapy, non-cytotoxic regimens, hormone therapy, or radiation therapy) include recurrent or persistent disease defined as having measurable disease per RECIST (Version 1.1)

    • Patients not on chemotherapy are also eligible and are not required to have RECIST criteria
  • Life expectancy of at least 6 months

  • Patients with any performance status, yet with the ability to verbally consent and participate in the first assessment

    • Study measures will be administered in the office/clinic setting, or for study participants who are unable to attend clinics, via telephone or mail (telephone is the preferred back-up means)
  • Patients may have or have had a prior non-gynecologic malignancy within 5 years prior to study enrollment; however, they must have completed all treatments for the disease and have no evidence of disease at the time of enrollment, and ovarian, peritoneal, or fallopian tube cancer must be the primary life-threatening diagnosis
  • Patient must be able to read and write English
  • No patients receiving chemotherapy for platinum-sensitive ovarian cancer, peritoneal, or fallopian tube cancer

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?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arm I
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Medical Chart Review
Ancillary studies
Other Names:
  • Chart Review
Procedure: Assessment of Therapy Complications
Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence and severity of patient-reported symptoms as measured by the NFOSI-18, the FACIT-F subscale, and the FACT/GOG-AD and NTX subscales
Time Frame: Up to 6 months
Assessed at baseline, and at 3 and 6 months. The prevalence of a patient-reported symptom will be determined by the percentage of living patients reporting the presence of a symptom at the assessment time point.
Up to 6 months

Collaborators and Investigators

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

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Vivian E von Gruenigen, 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)

April 12, 2011

Primary Completion (ACTUAL)

January 31, 2014

Study Registration Dates

First Submitted

June 11, 2011

First Submitted That Met QC Criteria

June 11, 2011

First Posted (ESTIMATE)

June 14, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 8, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-0267 (OTHER: CTEP)
  • U10CA101165 (U.S. NIH Grant/Contract)
  • NCI-2011-02547 (REGISTRY: CTRP (Clinical Trial Reporting Program))
  • CDR0000701477

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.

Clinical Trials on Fatigue

Clinical Trials on Quality-of-Life Assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe