Symptom Management in Patients With Recurrent or Persistent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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
4 other identifiers
interventional
485
1 country
144
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
144 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2009
CompletedFirst Posted
Study publicly available on registry
August 13, 2009
CompletedStudy Start
First participant enrolled
January 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2017
CompletedMarch 12, 2019
March 1, 2019
7 years
August 12, 2009
March 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Symptom severity, symptom-related distress, consequences, and control of symptoms as measured by the Symptom Representation Questionnaire
Baseline and at 4, 8, and 12 weeks
Secondary Outcomes (5)
Health-related quality of life as measured by the FACT-O
Baseline and at 4, 8, and 12 weeks, and every 4 weeks for 1 year
Depressive symptoms as measured by the CES-D short form
Baseline and at 4, 8, and 12 weeks, and every 4 weeks for 1 year
Communication with health care providers and use of self-care strategies assessed by investigator-developed survey
Baseline and at 4, 8, and 12 weeks
Implementation and perceived effectiveness of new symptom management strategies assessed by questionnaire
Baseline and at 4, 8, and 12 weeks
Barriers to symptom management as measured by the Symptom Management Barriers Questionnaire
Baseline and at 4, 8, and 12 weeks
Study Arms (3)
Arm I (nurse-assisted intervention module)
EXPERIMENTALPatients 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.
Arm II (self-directed intervention module)
EXPERIMENTALPatients 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.
Arm III (standard care from local provider)
ACTIVE COMPARATORPatients 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.
Interventions
Ancillary studies
Ancillary studies
Ancillary studies
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (144)
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, 85012, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, 94040, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Elkhart Clinic
Elkhart, Indiana, 46514-2098, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Community Howard Regional Health
Kokomo, Indiana, 46904, United States
IU Health La Porte Hospital
La Porte, Indiana, 46350, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, 46563, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, 46601, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, 46391, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266, United States
Providence Medical Center
Kansas City, Kansas, 66112, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Saint Luke's South Hospital
Overland Park, Kansas, 66213, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, 66208, United States
Shawnee Mission Medical Center-KCCC
Shawnee Mission, Kansas, 66204, United States
CHRISTUS Highland Medical Center
Shreveport, Louisiana, 71105, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, 01605, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, 49829, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, 49801, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
Lakeland Hospital Niles
Niles, Michigan, 49120, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, 49085, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview-Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Truman Medical Center
Kansas City, Missouri, 64108, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Saint Joseph Health Center
Kansas City, Missouri, 64114, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, 64118, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086, United States
Liberty Radiation Oncology Center
Liberty, Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64507, United States
Saint Joseph Oncology Inc
Saint Joseph, Missouri, 64507, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, 87106, United States
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, 88011, United States
Island Gynecologic Oncology
Brightwaters, New York, 11718, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, 44304, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
Main Line Health NCORP
Wynnewood, Pennsylvania, 19096, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
The Methodist Hospital System
Houston, Texas, 77030, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, 54476, United States
Related Publications (1)
Donovan HS, Sereika SM, Wenzel LB, Edwards RP, Knapp JE, Hughes SH, Roberge MC, Thomas TH, Klein SJ, Spring MB, Nolte S, Landrum LM, Casey AC, Mutch DG, DeBernardo RL, Muller CY, Sullivan SA, Ward SE. Effects of the WRITE Symptoms Interventions on Symptoms and Quality of Life Among Patients With Recurrent Ovarian Cancers: An NRG Oncology/GOG Study (GOG-0259). J Clin Oncol. 2022 May 1;40(13):1464-1473. doi: 10.1200/JCO.21.00656. Epub 2022 Feb 7.
PMID: 35130043DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heidi Donovan
Gynecologic Oncology Group
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2009
First Posted
August 13, 2009
Study Start
January 19, 2010
Primary Completion
January 8, 2017
Last Updated
March 12, 2019
Record last verified: 2019-03