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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:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00958698
First received: August 12, 2009
Last updated: August 23, 2017
Last verified: August 2017
  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. Developing a symptom management plan may help relieve symptoms related to cancer or cancer treatment and help improve quality of life.

Condition Intervention
Fallopian Tube Carcinoma Primary Peritoneal Carcinoma Psychological Impact of Cancer Recurrent Ovarian Carcinoma Other: Communication Intervention Other: Educational Intervention Other: Internet-Based Intervention Procedure: Psychosocial Assessment and Care Other: Quality-of-Life Assessment Other: Questionnaire Administration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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:
  • Symptom severity, symptom-related distress, consequences, and control of symptoms as measured by the Symptom Representation Questionnaire [ Time Frame: Baseline and at 4, 8, and 12 weeks ]

Secondary Outcome Measures:
  • Barriers to symptom management as measured by the Symptom Management Barriers Questionnaire [ Time Frame: Baseline and at 4, 8, and 12 weeks ]
  • Communication with health care providers and use of self-care strategies assessed by investigator-developed survey [ Time Frame: Baseline and at 4, 8, and 12 weeks ]
  • Depressive symptoms as measured by the CES-D short form [ Time Frame: Baseline and at 4, 8, and 12 weeks, and every 4 weeks for 1 year ]
  • Health-related quality of life as measured by the FACT-O [ Time Frame: Baseline and at 4, 8, and 12 weeks, and every 4 weeks for 1 year ]
  • Implementation and perceived effectiveness of new symptom management strategies assessed by questionnaire [ Time Frame: Baseline and at 4, 8, and 12 weeks ]

Enrollment: 485
Actual Study Start Date: January 19, 2010
Primary Completion Date: January 8, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (nurse-assisted intervention module)
Patients are given password-protected access to their own web-based message board to communicate with a research nurse. The nurse leads patients through WRITE Symptoms? intervention module, with personalized support and advice. The nurse will encourage the patient to try new selected strategies, continue with effective strategies, and work with local health care providers in an ongoing process to improve symptom management.
Other: Communication Intervention
Ancillary studies
Other: Educational Intervention
Ancillary studies
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Internet-Based Intervention
Ancillary studies
Procedure: Psychosocial Assessment and Care
Ancillary studies
Other Name: Psychosocial Care/Assessment
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Experimental: Arm II (self-directed intervention module)
Patients are given password-protected access to an interactive web-based computer program that will lead them through a modified WRITE Symptoms? intervention module (comprising the same elements as in arm I) without guidance and individualized recommendations from a nurse. Patients work through 3 selected symptoms using the WRITE Symptoms? intervention module over approximately 4 weeks. The program will generate an encouragement for the patient to try new selected strategies, continue with effective strategies, and continue the new approach to symptom management with local health care providers in an ongoing process to improve symptom management.
Other: Educational Intervention
Ancillary studies
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Internet-Based Intervention
Ancillary studies
Procedure: Psychosocial Assessment and Care
Ancillary studies
Other Name: Psychosocial Care/Assessment
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Active Comparator: Arm III (standard care from local provider)
Patients are given password-protected access to online questionnaires. Patients are prompted monthly to complete online questionnaires. Patients receive standard symptom management from their local health care providers.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • GOG performance status 0-2
  • Able to read and write English
  • Access to computer and the Internet required
  • 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
UCLA / 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, Illinois
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Memorial Medical Center
Springfield, Illinois, United States, 62781
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Elkhart Clinic
Elkhart, Indiana, United States, 46514-2098
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States, 46514
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Community Howard Regional Health
Kokomo, Indiana, United States, 46904
IU Health La Porte Hospital
La Porte, Indiana, United States, 46350
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States, 46545
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States, 46563
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC-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, 46628
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 Methodist Medical Center
Des Moines, Iowa, United States, 50309
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States, 50266
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 NCI Community Oncology Research Program
Prairie Village, Kansas, United States, 66208
Shawnee Mission Medical Center-KCCC
Shawnee, Kansas, United States, 66204
United States, Louisiana
CHRISTUS Highland Medical Center
Shreveport, Louisiana, United States, 71105
United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
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 Memorial Health Care
Worcester, Massachusetts, United States, 01605
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Michigan
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States, 49829
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
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
Lakeland Community Hospital
Niles, Michigan, United States, 49120
Lakeland Hospital
Saint Joseph, Michigan, United States, 49085
Marie Yeager Cancer Center
Saint 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/Masonic Cancer Center
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 Community Oncology Research Consortium
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 Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Truman Medical Center
Kansas City, Missouri, United States, 64108
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Saint Joseph Health Center
Kansas City, Missouri, United States, 64114
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States, 64118
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Radiation Oncology Center
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
United States, Montana
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
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
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87102
Southwest Gynecologic Oncology Associates Inc
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
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44307
Case Western Reserve University
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
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
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
Main Line Health NCORP
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
The Methodist Hospital System
Houston, Texas, United States, 77030
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center
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
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States, 54303
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
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
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Heidi Donovan Gynecologic Oncology Group
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00958698     History of Changes
Other Study ID Numbers: GOG-0259
NCI-2011-01950 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000648729
GOG-0259 ( Other Identifier: Gynecologic Oncology Group )
GOG-0259 ( Other Identifier: DCP )
GOG-0259 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
Study First Received: August 12, 2009
Last Updated: August 23, 2017

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on September 21, 2017