Quality of Life and Care Needs of Patients With Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
- Conditions
- AnxietyRecurrent Fallopian Tube CarcinomaStage IA Fallopian Tube Cancer AJCC v6 and v7Stage IIB Fallopian Tube Cancer AJCC v6 and v7Stage IIC Fallopian Tube Cancer AJCC v6 and v7Stage III Ovarian Cancer AJCC v6 and v7Stage IV Ovarian Cancer AJCC v6 and v7FatigueNausea and VomitingStage I Ovarian Cancer AJCC v6 and v7
- Interventions
- Procedure: Assessment of Therapy ComplicationsOther: Medical Chart ReviewOther: Quality-of-Life AssessmentOther: Questionnaire Administration
- Registration Number
- NCT01372787
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 103
-
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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm I Assessment of Therapy Complications - Arm I Medical Chart Review - Arm I Quality-of-Life Assessment - Arm I Questionnaire Administration -
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (144)
Delbert Day Cancer Institute at PCRMC
🇺🇸Rolla, Missouri, United States
Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Wayne State University/Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Ascension Saint John Hospital
🇺🇸Detroit, Michigan, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Saint Alphonsus Cancer Care Center-Boise
🇺🇸Boise, Idaho, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Cancer Center of Kansas - Pratt
🇺🇸Pratt, Kansas, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Good Samaritan Regional Health Center
🇺🇸Mount Vernon, Illinois, United States
Community Howard Regional Health
🇺🇸Kokomo, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka
🇺🇸Mishawaka, Indiana, United States
Michiana Hematology Oncology PC-Elkhart
🇺🇸Elkhart, Indiana, United States
Cancer Center of Kansas - Parsons
🇺🇸Parsons, Kansas, United States
Northern Indiana Cancer Research Consortium
🇺🇸South Bend, Indiana, United States
Cancer Center of Kansas - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas - Salina
🇺🇸Salina, Kansas, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Saint Luke's South Hospital
🇺🇸Overland Park, Kansas, United States
Cancer Center of Kansas - Wellington
🇺🇸Wellington, Kansas, United States
Wichita NCI Community Oncology Research Program
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
🇺🇸Winfield, Kansas, United States
Beaumont Hospital ? Dearborn
🇺🇸Dearborn, Michigan, United States
Genesys Regional Medical Center
🇺🇸Grand Blanc, Michigan, United States
Maine Medical Center-Bramhall Campus
🇺🇸Portland, Maine, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
University of Massachusetts Memorial Health Care
🇺🇸Worcester, Massachusetts, United States
Allegiance Health
🇺🇸Jackson, Michigan, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Saint Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
Saint Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Lakeland Medical Center Saint Joseph
🇺🇸Saint Joseph, Michigan, United States
Sparrow Hospital
🇺🇸Lansing, Michigan, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
William Beaumont Hospital-Royal Oak
🇺🇸Royal Oak, Michigan, United States
Metro Minnesota Community Oncology Research Consortium
🇺🇸Saint Louis Park, Minnesota, United States
Fairview-Southdale Hospital
🇺🇸Edina, Minnesota, United States
Unity Hospital
🇺🇸Fridley, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
🇺🇸Maplewood, Minnesota, United States
Saint Francis Regional Medical Center
🇺🇸Shakopee, Minnesota, United States
Saint Dominic-Jackson Memorial Hospital
🇺🇸Jackson, Mississippi, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
Rice Memorial Hospital
🇺🇸Willmar, Minnesota, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
State University of New York Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Cancer Research for the Ozarks NCORP
🇺🇸Springfield, Missouri, United States
Mercy Hospital Springfield
🇺🇸Springfield, Missouri, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
🇺🇸Mentor, Ohio, United States
Main Line Health NCORP
🇺🇸Wynnewood, Pennsylvania, United States
Atrium Health Cabarrus/LCI-Concord
🇺🇸Concord, North Carolina, United States
Women's Cancer Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
🇺🇸Tulsa, Oklahoma, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
Greenville Health System Cancer Institute-Eastside
🇺🇸Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Seneca
🇺🇸Seneca, South Carolina, United States
Scott and White Memorial Hospital
🇺🇸Temple, Texas, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Memorial Hermann Texas Medical Center
🇺🇸Houston, Texas, United States
Green Bay Oncology at Saint Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
🇺🇸Green Bay, Wisconsin, United States
Cancer Center of Western Wisconsin
🇺🇸New Richmond, Wisconsin, United States
CoxHealth South Hospital
🇺🇸Springfield, Missouri, United States
Saint John's Hospital - Healtheast
🇺🇸Maplewood, Minnesota, United States
New Ulm Medical Center
🇺🇸New Ulm, Minnesota, United States
North Memorial Medical Health Center
🇺🇸Robbinsdale, Minnesota, United States
Lakeview Hospital
🇺🇸Stillwater, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
🇺🇸Saint Louis Park, Minnesota, United States
Kansas City NCI Community Oncology Research Program
🇺🇸Prairie Village, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Associates In Womens Health
🇺🇸Wichita, Kansas, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Saint John Macomb-Oakland Hospital
🇺🇸Warren, Michigan, United States
Lake Huron Medical Center
🇺🇸Port Huron, Michigan, United States
Ascension Saint Mary's Hospital
🇺🇸Saginaw, Michigan, United States
Greenville Health System Cancer Institute-Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Marie Yeager Cancer Center
🇺🇸Saint Joseph, Michigan, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Michiana Hematology Oncology PC-Westville
🇺🇸Westville, Indiana, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
University of Hawaii Cancer Center
🇺🇸Honolulu, Hawaii, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Michigan Cancer Research Consortium NCORP
🇺🇸Ann Arbor, Michigan, United States
Saint Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
The Hospital of Central Connecticut
🇺🇸New Britain, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis
🇺🇸Hartford, Connecticut, United States
University of Chicago Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
🇺🇸Evanston, Illinois, United States
Sudarshan K Sharma MD Limited-Gynecologic Oncology
🇺🇸Hinsdale, Illinois, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Elkhart Clinic
🇺🇸Elkhart, Indiana, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Michiana Hematology Oncology PC-Mishawaka
🇺🇸Mishawaka, Indiana, United States
IU Health La Porte Hospital
🇺🇸La Porte, Indiana, United States
Michiana Hematology Oncology PC-South Bend
🇺🇸South Bend, Indiana, United States
Michiana Hematology Oncology PC-Plymouth
🇺🇸Plymouth, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
McFarland Clinic PC - Ames
🇺🇸Ames, Iowa, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Cancer Center of Kansas - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott
🇺🇸Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
University of Kansas Cancer Center
🇺🇸Kansas City, Kansas, United States
Cancer Center of Kansas - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas-Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas-Liberal
🇺🇸Liberal, Kansas, United States
Minnesota Oncology Hematology PA-Woodbury
🇺🇸Woodbury, Minnesota, United States
Saint Luke's East - Lee's Summit
🇺🇸Lee's Summit, Missouri, United States
Carolinas Medical Center/Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Summa Akron City Hospital/Cooper Cancer Center
🇺🇸Akron, Ohio, United States
Cleveland Clinic Akron General
🇺🇸Akron, Ohio, United States
Women and Infants Hospital
🇺🇸Providence, Rhode Island, United States
Greenville Health System Cancer Institute-Faris
🇺🇸Greenville, South Carolina, United States
Chattanooga's Program in Women's Oncology
🇺🇸Chattanooga, Tennessee, United States
Green Bay Oncology Limited at Saint Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
Holy Family Memorial Hospital
🇺🇸Manitowoc, Wisconsin, United States
Froedtert and the Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Research Medical Center
🇺🇸Kansas City, Missouri, United States
Iowa-Wide Oncology Research Coalition NCORP
🇺🇸Des Moines, Iowa, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel
🇺🇸Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States