Symptom Management in Patients With Recurrent or Persistent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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.
Key Facts
Lead Sponsor
Gynecologic Oncology Group
Enrollment
485
Start Date
2010-01-19
Completion Date
2017-01-08
Study Type
INTERVENTIONAL
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
Interventions
Conditions
Eligibility
Age Range
18 Years+
Sex
FEMALE
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
Outcome Measures
Primary Outcomes
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 Outcomes
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
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
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
Implementation and perceived effectiveness of new symptom management strategies assessed by questionnaire
Time frame: Baseline and at 4, 8, and 12 weeks
Barriers to symptom management as measured by the Symptom Management Barriers Questionnaire
Time frame: Baseline and at 4, 8, and 12 weeks
Locations
Gynecologic Oncology Group of Arizona, Phoenix, United States
Cedars Sinai Medical Center, Los Angeles, United States
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, United States
Palo Alto Medical Foundation-Gynecologic Oncology, Mountain View, United States
University of Colorado Hospital, Aurora, United States
Hartford Hospital, Hartford, United States
The Hospital of Central Connecticut, New Britain, United States
Queen's Medical Center, Honolulu, United States
University of Hawaii Cancer Center, Honolulu, United States
Kapiolani Medical Center for Women and Children, Honolulu, United States
Decatur Memorial Hospital, Decatur, United States
Memorial Medical Center, Springfield, United States
Carle Cancer Center, Urbana, United States
Elkhart Clinic, Elkhart, United States
Michiana Hematology Oncology PC-Elkhart, Elkhart, United States
Elkhart General Hospital, Elkhart, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, United States
Community Howard Regional Health, Kokomo, United States
IU Health La Porte Hospital, La Porte, United States
Michiana Hematology Oncology PC-Mishawaka, Mishawaka, United States
Saint Joseph Regional Medical Center-Mishawaka, Mishawaka, United States
Michiana Hematology Oncology PC-Plymouth, Plymouth, United States
Memorial Hospital of South Bend, South Bend, United States
Michiana Hematology Oncology PC-South Bend, South Bend, United States
South Bend Clinic, South Bend, United States
Northern Indiana Cancer Research Consortium, South Bend, United States
Michiana Hematology Oncology PC-Westville, Westville, United States
Medical Oncology and Hematology Associates-West Des Moines, Clive, United States
Mercy Cancer Center-West Lakes, Clive, United States
Iowa Methodist Medical Center, Des Moines, United States
Iowa-Wide Oncology Research Coalition NCORP, Des Moines, United States
Medical Oncology and Hematology Associates-Des Moines, Des Moines, United States
Medical Oncology and Hematology Associates-Laurel, Des Moines, United States
Mercy Medical Center - Des Moines, Des Moines, United States
Iowa Lutheran Hospital, Des Moines, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, United States
Methodist West Hospital, West Des Moines, United States
Mercy Medical Center-West Lakes, West Des Moines, United States
Providence Medical Center, Kansas City, United States
Menorah Medical Center, Overland Park, United States
Saint Luke's South Hospital, Overland Park, United States
Kansas City NCI Community Oncology Research Program, Prairie Village, United States
Shawnee Mission Medical Center-KCCC, Shawnee Mission, United States
CHRISTUS Highland Medical Center, Shreveport, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, United States
Walter Reed National Military Medical Center, Bethesda, United States
Massachusetts General Hospital Cancer Center, Boston, United States
Beth Israel Deaconess Medical Center, Boston, United States
University of Massachusetts Memorial Health Care, Worcester, United States
University of Massachusetts Medical School, Worcester, United States
Wayne State University/Karmanos Cancer Institute, Detroit, United States
Green Bay Oncology - Escanaba, Escanaba, United States
Spectrum Health at Butterworth Campus, Grand Rapids, United States
Green Bay Oncology - Iron Mountain, Iron Mountain, United States
Bronson Methodist Hospital, Kalamazoo, United States
West Michigan Cancer Center, Kalamazoo, United States
Borgess Medical Center, Kalamazoo, United States
Lakeland Hospital Niles, Niles, United States
William Beaumont Hospital-Royal Oak, Royal Oak, United States
Lakeland Medical Center Saint Joseph, Saint Joseph, United States
Marie Yeager Cancer Center, Saint Joseph, United States
Fairview Ridges Hospital, Burnsville, United States
Mercy Hospital, Coon Rapids, United States
Fairview-Southdale Hospital, Edina, United States
Unity Hospital, Fridley, United States
Hutchinson Area Health Care, Hutchinson, United States
Minnesota Oncology Hematology PA-Maplewood, Maplewood, United States
Saint John's Hospital - Healtheast, Maplewood, United States
Abbott-Northwestern Hospital, Minneapolis, United States
Hennepin County Medical Center, Minneapolis, United States
University of Minnesota/Masonic Cancer Center, Minneapolis, United States
New Ulm Medical Center, New Ulm, United States
North Memorial Medical Health Center, Robbinsdale, United States
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, United States
Regions Hospital, Saint Paul, United States
United Hospital, Saint Paul, United States
Saint Francis Regional Medical Center, Shakopee, United States
Lakeview Hospital, Stillwater, United States
Ridgeview Medical Center, Waconia, United States
Rice Memorial Hospital, Willmar, United States
Minnesota Oncology Hematology PA-Woodbury, Woodbury, United States
Truman Medical Center, Kansas City, United States
Saint Luke's Hospital of Kansas City, Kansas City, United States
Saint Joseph Health Center, Kansas City, United States
North Kansas City Hospital, Kansas City, United States
Heartland Hematology and Oncology Associates Incorporated, Kansas City, United States
Research Medical Center, Kansas City, United States
Saint Luke's East - Lee's Summit, Lee's Summit, United States
Liberty Radiation Oncology Center, Liberty, United States
Heartland Regional Medical Center, Saint Joseph, United States
Saint Joseph Oncology Inc, Saint Joseph, United States
Mercy Hospital Springfield, Springfield, United States
CoxHealth South Hospital, Springfield, United States
Washington University School of Medicine, St Louis, United States
Billings Clinic Cancer Center, Billings, United States
Nebraska Methodist Hospital, Omaha, United States
University of Nebraska Medical Center, Omaha, United States
University of New Mexico Cancer Center, Albuquerque, United States
Southwest Gynecologic Oncology Associates Inc, Albuquerque, United States
Memorial Medical Center - Las Cruces, Las Cruces, United States
Island Gynecologic Oncology, Brightwaters, United States
Summa Akron City Hospital/Cooper Cancer Center, Akron, United States
Cleveland Clinic Akron General, Akron, United States
Case Western Reserve University, Cleveland, United States
MetroHealth Medical Center, Cleveland, United States
Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, United States
Cleveland Clinic Foundation, Cleveland, United States
Ohio State University Comprehensive Cancer Center, Columbus, United States
Riverside Methodist Hospital, Columbus, United States
Miami Valley Hospital, Dayton, United States
Hillcrest Hospital Cancer Center, Mayfield Heights, United States
UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor, United States
University of Oklahoma Health Sciences Center, Oklahoma City, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, United States
Abington Memorial Hospital, Abington, United States
Lehigh Valley Hospital-Cedar Crest, Allentown, United States
Bryn Mawr Hospital, Bryn Mawr, United States
Paoli Memorial Hospital, Paoli, United States
UPMC-Magee Womens Hospital, Pittsburgh, United States
West Penn Hospital, Pittsburgh, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, United States
Lankenau Medical Center, Wynnewood, United States
Main Line Health NCORP, Wynnewood, United States
Women and Infants Hospital, Providence, United States
Medical University of South Carolina, Charleston, United States
The Methodist Hospital System, Houston, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, United States
Marshfield Clinic Cancer Center at Sacred Heart, Eau Claire, United States
Green Bay Oncology at Saint Vincent Hospital, Green Bay, United States
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, United States
Green Bay Oncology Limited at Saint Mary's Hospital, Green Bay, United States
Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay, United States
University of Wisconsin Hospital and Clinics, Madison, United States
Holy Family Memorial Hospital, Manitowoc, United States
Bay Area Medical Center, Marinette, United States
Marshfield Medical Center-Marshfield, Marshfield, United States
Aurora Saint Luke's Medical Center, Milwaukee, United States
Marshfield Clinic-Minocqua Center, Minocqua, United States
Saint Vincent Hospital Cancer Center at Oconto Falls, Oconto Falls, United States
Marshfield Medical Center-Rice Lake, Rice Lake, United States
Green Bay Oncology - Sturgeon Bay, Sturgeon Bay, United States
Aurora West Allis Medical Center, West Allis, United States
Marshfield Clinic - Weston Center, Weston, United States