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Trial record 1 of 1 for:    GOG 0259
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Symptom Management in Patients With Recurrent or Persistent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00958698
First received: August 12, 2009
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

RATIONALE: Developing a symptom management plan may help relieve symptoms related to cancer or cancer treatment and help improve quality of life.

PURPOSE: This randomized clinical trial is studying two different symptom management programs to see how well they work compared with usual care in patients with recurrent or persistent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.


Condition Intervention
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Psychosocial Effects of Cancer and Its Treatment
Other: communication intervention
Other: educational intervention
Other: internet-based intervention
Other: questionnaire administration
Other: study of socioeconomic and demographic variables
Procedure: assessment of therapy complications
Procedure: management of therapy complications
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Official Title: NURSE-DELIVERED WRITE SYMPTOMS© vs. SELF-DIRECTED WRITE SYMPTOMS© vs. CARE AS USUAL FOR OPTIMAL SYMPTOM MANAGEMENT FOR WOMEN WITH RECURRENT OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Severity, distress, consequences, and control of symptoms as measured by the Symptom Representation Questionnaire at baseline and at 4, 8, and 12 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related quality of life as measured by the FACT-O at baseline, at 4, 8, and 12 weeks, and then every 4 weeks for 1 year [ Designated as safety issue: No ]
  • Depressive symptoms as measured by the CES-D short form at baseline, at 4, 8, and 12 weeks, and then every 4 weeks for 1 year [ Designated as safety issue: No ]
  • Barriers to symptom management as measured by the Symptom Management Barriers Questionnaire at baseline and at 4, 8, and 12 weeks [ Designated as safety issue: No ]
  • Communication with health care providers as measured at baseline and at 4, 8, and 12 weeks [ Designated as safety issue: No ]
  • Change, use, and effectiveness of symptom management strategies as measured at baseline and at 4, 8, and 12 weeks [ Designated as safety issue: No ]
  • Mini-assessment of non-target symptoms as measured at baseline, at 4, 8, and 12 weeks, and then every 4 weeks for 1 year [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: January 2010
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of ovarian, fallopian tube, or primary peritoneal cancer that has recurred or persisted following primary therapy

    • Active disease or current treatment are not required
  • Must be experiencing ≥ 3 symptoms associated with ovarian cancer or cancer treatment, including, but not limited to, any of the following:

    • Abdominal bloating or cramping
    • Nausea, vomiting, or diarrhea
    • Constipation
    • Anorexia
    • Anxiety
    • Depression
    • Dizziness
    • Drowsiness
    • Dry mouth
    • Fatigue
    • Headaches
    • Hair loss
    • Hot flashes
    • Memory concerns
    • Mood swings
    • Mouth sores
    • Pain
    • Peripheral neuropathies
    • Sexuality concerns
    • Sleep disturbances
    • Shortness of breath
    • Skin rash or palmar-plantar erythrodysesthesia
    • Urinary problems
    • Weight gain or loss

PATIENT CHARACTERISTICS:

  • GOG performance status 0-2
  • Able to read and write English
  • Access to computer and the Internet required

PRIOR CONCURRENT THERAPY:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958698

  Hide Study Locations
Locations
United States, Arizona
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, United States, 85012
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States, 94040
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Hawaii
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Hawaii Minority Based CCOP
Honolulu, Hawaii, United States, 96813
University of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Carle Foundation - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States, 46514
Elkhart Clinic
Elkhart, Indiana, United States, 46514-2098
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Community Howard Regional Health
Kokomo, Indiana, United States, 46904
Indiana University Health La Porte Hospital
La Porte, Indiana, United States, 46350
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States, 46563
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
South Bend Clinic
South Bend, Indiana, United States, 46617
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology-PC Westville
Westville, Indiana, United States, 46391
United States, Iowa
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates
Des Moines, Iowa, United States, 50314
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States, 50266
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
United States, Kansas
Providence Medical Center
Kansas City, Kansas, United States, 66112
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Kansas City CCOP
Prairie Village, Kansas, United States, 66208
Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States, 66204
United States, Louisiana
Christus Schumpert Saint Mary's Place
Shreveport, Louisiana, United States, 71101
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287-8936
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, United States, 01605
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48202
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States, 49431
Gynecologic Oncology of West Michigan PLLC
Grand Rapids, Michigan, United States, 49546
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Michiana Hematology Oncology PC-Niles
Niles, Michigan, United States, 49120
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Lakeland Hospital
St. Joseph, Michigan, United States, 49085
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States, 55455
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States, 64118
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Research Medical Center
Kansas City, Missouri, United States, 64132
Truman Medical Center
Kansas City, Missouri, United States, 64108
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Saint Joseph Health Center
Kansas City, Missouri, United States, 64114
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Hospital
Liberty, Missouri, United States, 64068
Liberty Radiation Oncology Clinic
Liberty, Missouri, United States, 64068
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States, 64507
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Saint John's Hospital
Springfield, Missouri, United States, 65804
United States, Montana
Billings Clinic
Billings, Montana, United States, 59107-7000
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Mexico
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, United States, 87106
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, United States, 88011
United States, New York
Island Gynecologic Oncology
Brightwaters, New York, United States, 11718
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
Summa Akron City Hospital
Akron, Ohio, United States, 44304
Case Western Reserve University
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Cancer Care Associates-Yale
Tulsa, Oklahoma, United States, 74136-1929
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224-1791
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Mainline Health CCOP
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Methodist Hospital
Houston, Texas, United States, 77030
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Wisconsin
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States, 54701
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States, 54868
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Aurora Women's Pavilion of Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Heidi Donovan, RN, PhD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00958698     History of Changes
Other Study ID Numbers: GOG-0259, CDR0000648729, NCI-2011-01950
Study First Received: August 12, 2009
Last Updated: August 19, 2013
Health Authority: United States: National Cancer Institute

Keywords provided by Gynecologic Oncology Group:
psychosocial effects of cancer and its treatment
recurrent ovarian epithelial cancer
recurrent fallopian tube cancer
recurrent primary peritoneal cavity cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014