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.
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.
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
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There are 127 Locations for this study
Phoenix Arizona, 85012, United States
Los Angeles California, 90048, United States
Los Angeles California, 90095, United States
Mountain View California, 94040, United States
Aurora Colorado, 80045, United States
Hartford Connecticut, 06102, United States
New Britain Connecticut, 06050, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96826, United States
Decatur Illinois, 62526, United States
Springfield Illinois, 62781, United States
Urbana Illinois, 61801, United States
Elkhart Indiana, 46514, United States
Elkhart Indiana, 46514, United States
Elkhart Indiana, 46515, United States
Indianapolis Indiana, 46202, United States
Kokomo Indiana, 46904, United States
La Porte Indiana, 46350, United States
Mishawaka Indiana, 46545, United States
Mishawaka Indiana, 46545, United States
Plymouth Indiana, 46563, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46617, United States
South Bend Indiana, 46628, United States
Westville Indiana, 46391, United States
Clive Iowa, 50325, United States
Clive Iowa, 50325, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Iowa City Iowa, 52242, United States
West Des Moines Iowa, 50266, United States
West Des Moines Iowa, 50266, United States
Kansas City Kansas, 66112, United States
Overland Park Kansas, 66209, United States
Overland Park Kansas, 66213, United States
Prairie Village Kansas, 66208, United States
Shawnee Mission Kansas, 66204, United States
Shreveport Louisiana, 71105, United States
Baltimore Maryland, 21287, United States
Bethesda Maryland, 20889, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Worcester Massachusetts, 01605, United States
Worcester Massachusetts, 01655, United States
Detroit Michigan, 48201, United States
Escanaba Michigan, 49829, United States
Grand Rapids Michigan, 49503, United States
Iron Mountain Michigan, 49801, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49048, United States
Niles Michigan, 49120, United States
Royal Oak Michigan, 48073, United States
Saint Joseph Michigan, 49085, United States
Saint Joseph Michigan, 49085, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Hutchinson Minnesota, 55350, United States
Maplewood Minnesota, 55109, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Minneapolis Minnesota, 55455, United States
New Ulm Minnesota, 56073, United States
Robbinsdale Minnesota, 55422, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
Stillwater Minnesota, 55082, United States
Waconia Minnesota, 55387, United States
Willmar Minnesota, 56201, United States
Woodbury Minnesota, 55125, United States
Kansas City Missouri, 64108, United States
Kansas City Missouri, 64111, United States
Kansas City Missouri, 64114, United States
Kansas City Missouri, 64116, United States
Kansas City Missouri, 64118, United States
Kansas City Missouri, 64132, United States
Lee's Summit Missouri, 64086, United States
Liberty Missouri, 64068, United States
Saint Joseph Missouri, 64507, United States
Saint Joseph Missouri, 64507, United States
Saint Louis Missouri, 63110, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Omaha Nebraska, 68114, United States
Omaha Nebraska, 68198, United States
Albuquerque New Mexico, 87102, United States
Albuquerque New Mexico, 87106, United States
Las Cruces New Mexico, 88011, United States
Brightwaters New York, 11718, United States
Akron Ohio, 44304, United States
Akron Ohio, 44307, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44109, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43214, United States
Dayton Ohio, 45409, United States
Mayfield Heights Ohio, 44124, United States
Mentor Ohio, 44060, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74146, United States
Abington Pennsylvania, 19001, United States
Allentown Pennsylvania, 18103, United States
Bryn Mawr Pennsylvania, 19010, United States
Paoli Pennsylvania, 19301, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15224, United States
Pittsburgh Pennsylvania, 15232, United States
Wynnewood Pennsylvania, 19096, United States
Wynnewood Pennsylvania, 19096, United States
Providence Rhode Island, 02905, United States
Charleston South Carolina, 29425, United States
Houston Texas, 77030, United States
Richmond Virginia, 23298, United States
Eau Claire Wisconsin, 54701, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54303, United States
Madison Wisconsin, 53792, United States
Manitowoc Wisconsin, 54221, United States
Marinette Wisconsin, 54143, United States
Marshfield Wisconsin, 54449, United States
Milwaukee Wisconsin, 53215, United States
Minocqua Wisconsin, 54548, United States
Oconto Falls Wisconsin, 54154, United States
Rice Lake Wisconsin, 54868, United States
Sturgeon Bay Wisconsin, 54235, United States
West Allis Wisconsin, 53227, United States
Weston Wisconsin, 54476, United States
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