Ovarian Cancer Clinical Trial

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.

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Full Description

PRIMARY OBJECTIVE:

I. Compare the efficacy of nurse-delivered WRITE Symptoms? and self-directed WRITE Symptoms? vs usual care interventions in improving target symptom representations (i.e., decreases in symptom severity, symptom-related distress, and symptom consequences as measured by the Symptom Representation Questionnaire [SRQ]) in patients with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer.

SECONDARY OBJECTIVES:

I. Compare the efficacy of nurse-delivered WRITE Symptoms? vs self-directed WRITE Symptoms? vs usual care interventions in improving target symptom representations in these patients at 4 weeks.

II. Compare the efficacy of nurse-delivered WRITE Symptoms? vs self-directed WRITE Symptoms? vs usual care interventions in improving target symptom controllability in these patients at 4, 8, and 12 weeks.

III. Compare the efficacy of nurse-delivered WRITE Symptoms? vs self-directed WRITE Symptoms? vs usual care interventions in improving indicators of quality of life (QOL) of these patients as measured by the FACT-O and the CES-Depression inventory short form at 4, 8, and 12 weeks.

IV. Compare the efficacy of nurse-delivered WRITE Symptoms? vs self-directed WRITE Symptoms? vs usual care interventions in improving communication with health care providers about symptoms, implementation of new symptom management strategies (health care provider recommended as well as patient-initiated changes), and perceived effectiveness of strategies (health care provider recommended as well as patient-initiated changes) in these patients at 4, 8, and 12 weeks.

V. Compare the efficacy of nurse-delivered WRITE Symptoms? vs self-directed WRITE Symptoms? vs usual care interventions in improving patient-related barriers to symptom management as measured by the Symptom Management Barriers Questionnaire at 4, 8, and 12 weeks.

EXPLORATORY OBJECTIVES:

I. Compare trajectories of change for overall symptom severity in patients undergoing nurse-delivered WRITE Symptoms? vs self-directed WRITE Symptoms? vs usual care interventions using monthly assessments to explore potential long-term effects of the WRITE Symptoms? interventions.

II. Compare trajectories of change for QOL of patients undergoing nurse-delivered WRITE Symptoms? vs self-directed WRITE Symptoms? vs usual care interventions using monthly assessments to explore potential long-term effects of the WRITE Symptoms? interventions.

III. Compare trajectories of change for symptom severity, distress, communication, and implementation of new strategies for non-targeted symptoms in patients undergoing nurse-delivered WRITE Symptoms? vs self-directed WRITE Symptoms? vs usual care interventions using monthly assessments to explore whether patients are able to generalize the symptom management approaches taught in WRITE Symptoms? interventions to their other non-targeted symptoms.

IV. Explore whether changes in symptom representations mediate changes in QOL of these patients at 8 and 12 weeks.

V. Explore whether effects of the WRITE Symptoms? interventions on primary and secondary endpoints at 8 and 12 weeks differ based on the following patient characteristics assessed at baseline: age, education, and ethnicity; depression as measured by the CES-D short form; trait anxiety as measured by the STAI; optimism as measured by the LOT-R; social support as measured by the ISEL; and symptom severity as measured by the SRQ.

OUTLINE: This is a multicenter study. Patients are stratified according to race/ethnicity (non-Hispanic white vs Hispanic or non-white). Patients are randomized to 1 of 3 intervention arms.

ARM I (nurse-delivered intervention): Patients are given password-protected access to their own web-based message board to communicate with a research nurse. The nurse leads the patient through the WRITE Symptoms? intervention module comprising representational assessment; exploring concerns/misconceptions/gaps/confusions; creating conditions for conceptual change; introducing new information, goal setting, and development of a symptom management plan; and summary via asynchronous postings to the patient's message board. Patients work through 3 selected symptoms using the nurse-delivered WRITE Symptoms? intervention module over approximately 4 weeks. Two weeks later, the patient's symptom management strategy and their desire to make further changes are evaluated by additional interaction with the nurse via the message board. 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. Patients are given access to a resource guide that includes self-care guides for 26 symptoms. They are encouraged to use the same process taught for their 3 selected symptoms for any other symptoms that arise after the course of the intervention.

ARM II (self-directed intervention): 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. Two weeks later, patients are prompted by the computer program to respond to questions about their symptom management strategy and their desire to make further changes. 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. Patients are given access to a resource guide that includes self-care guides for 26 symptoms. They are encouraged to use the same process taught for their 3 selected symptoms for any other symptoms that arise after the course of the intervention.

ARM III (usual care): 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.

In all arms, patients complete online questionnaires to assess outcome measures at baseline, at 4, 8, and 12 weeks, and then every 4 weeks for 1 year.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

485

Study ID:

NCT00958698

Recruitment Status:

Unknown status

Sponsor:

Gynecologic Oncology Group

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There are 127 Locations for this study

See Locations Near You

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, 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, 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, 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
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Mercy Hospital Springfield
Springfield Missouri, 65804, United States
CoxHealth South Hospital
Springfield Missouri, 65807, 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, 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

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

485

Study ID:

NCT00958698

Recruitment Status:

Unknown status

Sponsor:


Gynecologic Oncology Group

How clear is this clinincal trial information?

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