- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00958698
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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
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Arizona
-
Phoenix, Arizona, Vereinigte Staaten, 85012
- Gynecologic Oncology Group of Arizona
-
-
California
-
Los Angeles, California, Vereinigte Staaten, 90095
- UCLA / Jonsson Comprehensive Cancer Center
-
Los Angeles, California, Vereinigte Staaten, 90048
- Cedars Sinai Medical Center
-
Mountain View, California, Vereinigte Staaten, 94040
- Palo Alto Medical Foundation-Gynecologic Oncology
-
-
Colorado
-
Aurora, Colorado, Vereinigte Staaten, 80045
- University of Colorado Hospital
-
-
Connecticut
-
Hartford, Connecticut, Vereinigte Staaten, 06102
- Hartford Hospital
-
New Britain, Connecticut, Vereinigte Staaten, 06050
- The Hospital of Central Connecticut
-
-
Hawaii
-
Honolulu, Hawaii, Vereinigte Staaten, 96813
- Queen's Medical Center
-
Honolulu, Hawaii, Vereinigte Staaten, 96813
- University of Hawaii Cancer Center
-
Honolulu, Hawaii, Vereinigte Staaten, 96826
- Kapiolani Medical Center for Women and Children
-
-
Illinois
-
Decatur, Illinois, Vereinigte Staaten, 62526
- Decatur Memorial Hospital
-
Springfield, Illinois, Vereinigte Staaten, 62781
- Memorial Medical Center
-
Urbana, Illinois, Vereinigte Staaten, 61801
- Carle Cancer Center
-
-
Indiana
-
Elkhart, Indiana, Vereinigte Staaten, 46515
- Elkhart General Hospital
-
Elkhart, Indiana, Vereinigte Staaten, 46514
- Michiana Hematology Oncology PC-Elkhart
-
Elkhart, Indiana, Vereinigte Staaten, 46514-2098
- Elkhart Clinic
-
Indianapolis, Indiana, Vereinigte Staaten, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
-
Kokomo, Indiana, Vereinigte Staaten, 46904
- Community Howard Regional Health
-
La Porte, Indiana, Vereinigte Staaten, 46350
- IU Health La Porte Hospital
-
Mishawaka, Indiana, Vereinigte Staaten, 46545
- Michiana Hematology Oncology PC-Mishawaka
-
Mishawaka, Indiana, Vereinigte Staaten, 46545
- Saint Joseph Regional Medical Center-Mishawaka
-
Plymouth, Indiana, Vereinigte Staaten, 46563
- Michiana Hematology Oncology PC-Plymouth
-
South Bend, Indiana, Vereinigte Staaten, 46601
- Memorial Hospital of South Bend
-
South Bend, Indiana, Vereinigte Staaten, 46601
- Michiana Hematology Oncology PC-South Bend
-
South Bend, Indiana, Vereinigte Staaten, 46628
- Northern Indiana Cancer Research Consortium
-
South Bend, Indiana, Vereinigte Staaten, 46617
- South Bend Clinic
-
Westville, Indiana, Vereinigte Staaten, 46391
- Michiana Hematology Oncology PC-Westville
-
-
Iowa
-
Clive, Iowa, Vereinigte Staaten, 50325
- Mercy Cancer Center-West Lakes
-
Clive, Iowa, Vereinigte Staaten, 50325
- Medical Oncology and Hematology Associates-West Des Moines
-
Des Moines, Iowa, Vereinigte Staaten, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, Vereinigte Staaten, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Vereinigte Staaten, 50309
- Medical Oncology and Hematology Associates-Des Moines
-
Des Moines, Iowa, Vereinigte Staaten, 50316
- Iowa Lutheran Hospital
-
Des Moines, Iowa, Vereinigte Staaten, 50309
- Iowa-Wide Oncology Research Coalition NCORP
-
Des Moines, Iowa, Vereinigte Staaten, 50314
- Medical Oncology and Hematology Associates-Laurel
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Iowa City, Iowa, Vereinigte Staaten, 52242
- University of Iowa/Holden Comprehensive Cancer Center
-
West Des Moines, Iowa, Vereinigte Staaten, 50266-7700
- Methodist West Hospital
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West Des Moines, Iowa, Vereinigte Staaten, 50266
- Mercy Medical Center-West Lakes
-
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Kansas
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Kansas City, Kansas, Vereinigte Staaten, 66112
- Providence Medical Center
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Overland Park, Kansas, Vereinigte Staaten, 66209
- Menorah Medical Center
-
Overland Park, Kansas, Vereinigte Staaten, 66213
- Saint Luke's South Hospital
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Prairie Village, Kansas, Vereinigte Staaten, 66208
- Kansas City NCI Community Oncology Research Program
-
Shawnee Mission, Kansas, Vereinigte Staaten, 66204
- Shawnee Mission Medical Center-KCCC
-
-
Louisiana
-
Shreveport, Louisiana, Vereinigte Staaten, 71105
- CHRISTUS Highland Medical Center
-
-
Maryland
-
Baltimore, Maryland, Vereinigte Staaten, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
Bethesda, Maryland, Vereinigte Staaten, 20889-5600
- Walter Reed National Military Medical Center
-
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Massachusetts
-
Boston, Massachusetts, Vereinigte Staaten, 02215
- Beth Israel Deaconess Medical Center
-
Boston, Massachusetts, Vereinigte Staaten, 02114
- Massachusetts General Hospital Cancer Center
-
Worcester, Massachusetts, Vereinigte Staaten, 01655
- University of Massachusetts Medical School
-
Worcester, Massachusetts, Vereinigte Staaten, 01605
- University of Massachusetts Memorial Health Care
-
-
Michigan
-
Detroit, Michigan, Vereinigte Staaten, 48201
- Wayne State University/Karmanos Cancer Institute
-
Escanaba, Michigan, Vereinigte Staaten, 49829
- Green Bay Oncology - Escanaba
-
Grand Rapids, Michigan, Vereinigte Staaten, 49503
- Spectrum Health at Butterworth Campus
-
Iron Mountain, Michigan, Vereinigte Staaten, 49801
- Green Bay Oncology - Iron Mountain
-
Kalamazoo, Michigan, Vereinigte Staaten, 49007
- West Michigan Cancer Center
-
Kalamazoo, Michigan, Vereinigte Staaten, 49007
- Bronson Methodist Hospital
-
Kalamazoo, Michigan, Vereinigte Staaten, 49048
- Borgess Medical Center
-
Niles, Michigan, Vereinigte Staaten, 49120
- Lakeland Hospital Niles
-
Royal Oak, Michigan, Vereinigte Staaten, 48073
- William Beaumont Hospital-Royal Oak
-
Saint Joseph, Michigan, Vereinigte Staaten, 49085
- Lakeland Medical Center Saint Joseph
-
Saint Joseph, Michigan, Vereinigte Staaten, 49085
- Marie Yeager Cancer Center
-
-
Minnesota
-
Burnsville, Minnesota, Vereinigte Staaten, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, Vereinigte Staaten, 55433
- Mercy Hospital
-
Edina, Minnesota, Vereinigte Staaten, 55435
- Fairview-Southdale Hospital
-
Fridley, Minnesota, Vereinigte Staaten, 55432
- Unity Hospital
-
Hutchinson, Minnesota, Vereinigte Staaten, 55350
- Hutchinson Area Health Care
-
Maplewood, Minnesota, Vereinigte Staaten, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, Vereinigte Staaten, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, Vereinigte Staaten, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, Vereinigte Staaten, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, Vereinigte Staaten, 55455
- University of Minnesota/Masonic Cancer Center
-
New Ulm, Minnesota, Vereinigte Staaten, 56073
- New Ulm Medical Center
-
Robbinsdale, Minnesota, Vereinigte Staaten, 55422
- North Memorial Medical Health Center
-
Saint Louis Park, Minnesota, Vereinigte Staaten, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Louis Park, Minnesota, Vereinigte Staaten, 55416
- Metro Minnesota Community Oncology Research Consortium
-
Saint Paul, Minnesota, Vereinigte Staaten, 55101
- Regions Hospital
-
Saint Paul, Minnesota, Vereinigte Staaten, 55102
- United Hospital
-
Shakopee, Minnesota, Vereinigte Staaten, 55379
- Saint Francis Regional Medical Center
-
Stillwater, Minnesota, Vereinigte Staaten, 55082
- Lakeview Hospital
-
Waconia, Minnesota, Vereinigte Staaten, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, Vereinigte Staaten, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, Vereinigte Staaten, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
-
Missouri
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Kansas City, Missouri, Vereinigte Staaten, 64116
- North Kansas City Hospital
-
Kansas City, Missouri, Vereinigte Staaten, 64111
- Saint Luke's Hospital of Kansas City
-
Kansas City, Missouri, Vereinigte Staaten, 64132
- Research Medical Center
-
Kansas City, Missouri, Vereinigte Staaten, 64108
- Truman Medical Center
-
Kansas City, Missouri, Vereinigte Staaten, 64118
- Heartland Hematology and Oncology Associates Incorporated
-
Kansas City, Missouri, Vereinigte Staaten, 64114
- Saint Joseph Health Center
-
Lee's Summit, Missouri, Vereinigte Staaten, 64086
- Saint Luke's East - Lee's Summit
-
Liberty, Missouri, Vereinigte Staaten, 64068
- Liberty Radiation Oncology Center
-
Saint Joseph, Missouri, Vereinigte Staaten, 64507
- Saint Joseph Oncology Inc
-
Saint Joseph, Missouri, Vereinigte Staaten, 64507
- Heartland Regional Medical Center
-
Saint Louis, Missouri, Vereinigte Staaten, 63110
- Washington University School of Medicine
-
Springfield, Missouri, Vereinigte Staaten, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, Vereinigte Staaten, 65804
- Mercy Hospital Springfield
-
-
Montana
-
Billings, Montana, Vereinigte Staaten, 59101
- Billings Clinic Cancer Center
-
-
Nebraska
-
Omaha, Nebraska, Vereinigte Staaten, 68114
- Nebraska Methodist Hospital
-
Omaha, Nebraska, Vereinigte Staaten, 68198
- University Of Nebraska Medical Center
-
-
New Mexico
-
Albuquerque, New Mexico, Vereinigte Staaten, 87102
- University of New Mexico Cancer Center
-
Albuquerque, New Mexico, Vereinigte Staaten, 87106
- Southwest Gynecologic Oncology Associates Inc
-
Las Cruces, New Mexico, Vereinigte Staaten, 88011
- Memorial Medical Center - Las Cruces
-
-
New York
-
Brightwaters, New York, Vereinigte Staaten, 11718
- Island Gynecologic Oncology
-
-
Ohio
-
Akron, Ohio, Vereinigte Staaten, 44307
- Cleveland Clinic Akron General
-
Akron, Ohio, Vereinigte Staaten, 44304
- Summa Akron City Hospital/Cooper Cancer Center
-
Cleveland, Ohio, Vereinigte Staaten, 44106
- Case Western Reserve University
-
Cleveland, Ohio, Vereinigte Staaten, 44109
- MetroHealth Medical Center
-
Cleveland, Ohio, Vereinigte Staaten, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Vereinigte Staaten, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital
-
Columbus, Ohio, Vereinigte Staaten, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, Vereinigte Staaten, 43210
- Ohio State University Comprehensive Cancer Center
-
Dayton, Ohio, Vereinigte Staaten, 45409
- Miami Valley Hospital
-
Mayfield Heights, Ohio, Vereinigte Staaten, 44124
- Hillcrest Hospital Cancer Center
-
Mentor, Ohio, Vereinigte Staaten, 44060
- UH Seidman Cancer Center at Lake Health Mentor Campus
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Vereinigte Staaten, 73104
- University of Oklahoma Health Sciences Center
-
Tulsa, Oklahoma, Vereinigte Staaten, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
-
-
Pennsylvania
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Abington, Pennsylvania, Vereinigte Staaten, 19001
- Abington Memorial Hospital
-
Allentown, Pennsylvania, Vereinigte Staaten, 18103
- Lehigh Valley Hospital-Cedar Crest
-
Bryn Mawr, Pennsylvania, Vereinigte Staaten, 19010
- Bryn Mawr Hospital
-
Paoli, Pennsylvania, Vereinigte Staaten, 19301
- Paoli Memorial Hospital
-
Pittsburgh, Pennsylvania, Vereinigte Staaten, 15224
- West Penn Hospital
-
Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
- UPMC-Magee Womens Hospital
-
Pittsburgh, Pennsylvania, Vereinigte Staaten, 15232
- University of Pittsburgh Cancer Institute (UPCI)
-
Wynnewood, Pennsylvania, Vereinigte Staaten, 19096
- Lankenau Medical Center
-
Wynnewood, Pennsylvania, Vereinigte Staaten, 19096
- Main Line Health NCORP
-
-
Rhode Island
-
Providence, Rhode Island, Vereinigte Staaten, 02905
- Women and Infants Hospital
-
-
South Carolina
-
Charleston, South Carolina, Vereinigte Staaten, 29425
- Medical University of South Carolina
-
-
Texas
-
Houston, Texas, Vereinigte Staaten, 77030
- The Methodist Hospital System
-
-
Virginia
-
Richmond, Virginia, Vereinigte Staaten, 23298
- Virginia Commonwealth University/Massey Cancer Center
-
-
Wisconsin
-
Eau Claire, Wisconsin, Vereinigte Staaten, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
-
Green Bay, Wisconsin, Vereinigte Staaten, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, Vereinigte Staaten, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Green Bay, Wisconsin, Vereinigte Staaten, 54303
- Green Bay Oncology Limited at Saint Mary's Hospital
-
Green Bay, Wisconsin, Vereinigte Staaten, 54301-3526
- Green Bay Oncology at Saint Vincent Hospital
-
Madison, Wisconsin, Vereinigte Staaten, 53792
- University of Wisconsin Hospital and Clinics
-
Manitowoc, Wisconsin, Vereinigte Staaten, 54221
- Holy Family Memorial Hospital
-
Marinette, Wisconsin, Vereinigte Staaten, 54143
- Bay Area Medical Center
-
Marshfield, Wisconsin, Vereinigte Staaten, 54449
- Marshfield Medical Center-Marshfield
-
Milwaukee, Wisconsin, Vereinigte Staaten, 53215
- Aurora Saint Luke's Medical Center
-
Minocqua, Wisconsin, Vereinigte Staaten, 54548
- Marshfield Clinic-Minocqua Center
-
Oconto Falls, Wisconsin, Vereinigte Staaten, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
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Rice Lake, Wisconsin, Vereinigte Staaten, 54868
- Marshfield Medical Center-Rice Lake
-
Sturgeon Bay, Wisconsin, Vereinigte Staaten, 54235
- Green Bay Oncology - Sturgeon Bay
-
West Allis, Wisconsin, Vereinigte Staaten, 53227
- Aurora West Allis Medical Center
-
Weston, Wisconsin, Vereinigte Staaten, 54476
- Marshfield Clinic - Weston Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Arm I (nurse-assisted intervention module)
Patients 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.
|
Nebenstudien
Andere Namen:
Nebenstudien
Nebenstudien
Andere Namen:
Ancillary studies
Ancillary studies
Andere Namen:
Ancillary studies
|
Experimental: Arm II (self-directed intervention module)
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.
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.
|
Nebenstudien
Andere Namen:
Nebenstudien
Nebenstudien
Andere Namen:
Ancillary studies
Andere Namen:
Ancillary studies
|
Aktiver Komparator: Arm III (standard care from local provider)
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.
|
Nebenstudien
Andere Namen:
Nebenstudien
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Symptom severity, symptom-related distress, consequences, and control of symptoms as measured by the Symptom Representation Questionnaire
Zeitfenster: Baseline and at 4, 8, and 12 weeks
|
Baseline and at 4, 8, and 12 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Health-related quality of life as measured by the FACT-O
Zeitfenster: Baseline and at 4, 8, and 12 weeks, and every 4 weeks for 1 year
|
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
Zeitfenster: Baseline and at 4, 8, and 12 weeks, and every 4 weeks for 1 year
|
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
Zeitfenster: Baseline and at 4, 8, and 12 weeks
|
Baseline and at 4, 8, and 12 weeks
|
Implementation and perceived effectiveness of new symptom management strategies assessed by questionnaire
Zeitfenster: Baseline and at 4, 8, and 12 weeks
|
Baseline and at 4, 8, and 12 weeks
|
Barriers to symptom management as measured by the Symptom Management Barriers Questionnaire
Zeitfenster: Baseline and at 4, 8, and 12 weeks
|
Baseline and at 4, 8, and 12 weeks
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Heidi Donovan, Gynecologic Oncology Group
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- GOG-0259 (Andere Kennung: CTEP)
- U10CA101165 (US NIH Stipendium/Vertrag)
- NCI-2011-01950 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
- CDR0000648729
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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Endo PharmaceuticalsAbgeschlossen
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Brookdale University Hospital Medical CenterUnbekanntCarcinoma in situ des Gebärmutterhalses | Zervikale intraepitheliale Neoplasien | Hochgradige zervikale intraepitheliale NeoplasieVereinigte Staaten
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Danish Breast Cancer Cooperative GroupDanish Cancer SocietyAktiv, nicht rekrutierendBrustkrebs | Carcinoma in situ der BrustDänemark
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Thomas Jefferson UniversityRekrutierungBrustkrebs | Invasiver Brustkrebs | Carcinoma in situ der BrustVereinigte Staaten
Klinische Studien zur Bewertung der Lebensqualität
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Memorial Sloan Kettering Cancer CenterAbgeschlossenAszitesVereinigte Staaten
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Kutahya Health Sciences UniversityAbgeschlossenChronischer Schmerz | Juvenile idiopathische ArthritisTruthahn
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Maastricht UniversityTNO; Netherlands Instititute for Health Services Research; University of TwenteAbgeschlossenHerzfehler | Diabetes mellitus, Typ 2 | Chronisch obstruktive Lungenerkrankung | AsthmaNiederlande
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Avicenna Military HospitalAbgeschlossenPostoperative GenesungMarokko
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Akdeniz UniversityAbgeschlossen
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Beijing Tsinghua Chang Gung HospitalRekrutierungPostoperative Komplikationen | Schlaganfall | Schwerwiegende unerwünschte kardiale Ereignisse | ModelleChina
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Memorial Sloan Kettering Cancer CenterBeendetDie Familien oder nächsten Angehörigen von Patienten, die am MSKCC wegen nichtkutaner Plattenepithelkarzinome behandelt wurden | Oberer AerodigestivtraktVereinigte Staaten
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Buddhist Tzu Chi General HospitalAbgeschlossen
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Hürriyet YılmazMedipol UniversityAbgeschlossenAdoleszente idiopathische Skoliose | Gesundheitsbezogene LebensqualitätTruthahn
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Baskent UniversityAbgeschlossenParodontitis, Erwachsener