- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Arizona
-
Phoenix, Arizona, Förenta staterna, 85012
- Gynecologic Oncology Group of Arizona
-
-
California
-
Los Angeles, California, Förenta staterna, 90095
- UCLA / Jonsson Comprehensive Cancer Center
-
Los Angeles, California, Förenta staterna, 90048
- Cedars Sinai Medical Center
-
Mountain View, California, Förenta staterna, 94040
- Palo Alto Medical Foundation-Gynecologic Oncology
-
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Colorado
-
Aurora, Colorado, Förenta staterna, 80045
- University of Colorado Hospital
-
-
Connecticut
-
Hartford, Connecticut, Förenta staterna, 06102
- Hartford Hospital
-
New Britain, Connecticut, Förenta staterna, 06050
- The Hospital of Central Connecticut
-
-
Hawaii
-
Honolulu, Hawaii, Förenta staterna, 96813
- Queen's Medical Center
-
Honolulu, Hawaii, Förenta staterna, 96813
- University of Hawaii Cancer Center
-
Honolulu, Hawaii, Förenta staterna, 96826
- Kapiolani Medical Center for Women and Children
-
-
Illinois
-
Decatur, Illinois, Förenta staterna, 62526
- Decatur Memorial Hospital
-
Springfield, Illinois, Förenta staterna, 62781
- Memorial Medical Center
-
Urbana, Illinois, Förenta staterna, 61801
- Carle Cancer Center
-
-
Indiana
-
Elkhart, Indiana, Förenta staterna, 46515
- Elkhart General Hospital
-
Elkhart, Indiana, Förenta staterna, 46514
- Michiana Hematology Oncology PC-Elkhart
-
Elkhart, Indiana, Förenta staterna, 46514-2098
- Elkhart Clinic
-
Indianapolis, Indiana, Förenta staterna, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
-
Kokomo, Indiana, Förenta staterna, 46904
- Community Howard Regional Health
-
La Porte, Indiana, Förenta staterna, 46350
- IU Health La Porte Hospital
-
Mishawaka, Indiana, Förenta staterna, 46545
- Michiana Hematology Oncology PC-Mishawaka
-
Mishawaka, Indiana, Förenta staterna, 46545
- Saint Joseph Regional Medical Center-Mishawaka
-
Plymouth, Indiana, Förenta staterna, 46563
- Michiana Hematology Oncology PC-Plymouth
-
South Bend, Indiana, Förenta staterna, 46601
- Memorial Hospital of South Bend
-
South Bend, Indiana, Förenta staterna, 46601
- Michiana Hematology Oncology PC-South Bend
-
South Bend, Indiana, Förenta staterna, 46628
- Northern Indiana Cancer Research Consortium
-
South Bend, Indiana, Förenta staterna, 46617
- South Bend Clinic
-
Westville, Indiana, Förenta staterna, 46391
- Michiana Hematology Oncology PC-Westville
-
-
Iowa
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Clive, Iowa, Förenta staterna, 50325
- Mercy Cancer Center-West Lakes
-
Clive, Iowa, Förenta staterna, 50325
- Medical Oncology and Hematology Associates-West Des Moines
-
Des Moines, Iowa, Förenta staterna, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, Förenta staterna, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Förenta staterna, 50309
- Medical Oncology and Hematology Associates-Des Moines
-
Des Moines, Iowa, Förenta staterna, 50316
- Iowa Lutheran Hospital
-
Des Moines, Iowa, Förenta staterna, 50309
- Iowa-Wide Oncology Research Coalition NCORP
-
Des Moines, Iowa, Förenta staterna, 50314
- Medical Oncology and Hematology Associates-Laurel
-
Iowa City, Iowa, Förenta staterna, 52242
- University of Iowa/Holden Comprehensive Cancer Center
-
West Des Moines, Iowa, Förenta staterna, 50266-7700
- Methodist West Hospital
-
West Des Moines, Iowa, Förenta staterna, 50266
- Mercy Medical Center-West Lakes
-
-
Kansas
-
Kansas City, Kansas, Förenta staterna, 66112
- Providence Medical Center
-
Overland Park, Kansas, Förenta staterna, 66209
- Menorah Medical Center
-
Overland Park, Kansas, Förenta staterna, 66213
- Saint Luke's South Hospital
-
Prairie Village, Kansas, Förenta staterna, 66208
- Kansas City NCI Community Oncology Research Program
-
Shawnee Mission, Kansas, Förenta staterna, 66204
- Shawnee Mission Medical Center-KCCC
-
-
Louisiana
-
Shreveport, Louisiana, Förenta staterna, 71105
- CHRISTUS Highland Medical Center
-
-
Maryland
-
Baltimore, Maryland, Förenta staterna, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
Bethesda, Maryland, Förenta staterna, 20889-5600
- Walter Reed National Military Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02215
- Beth Israel Deaconess Medical Center
-
Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital Cancer Center
-
Worcester, Massachusetts, Förenta staterna, 01655
- University of Massachusetts Medical School
-
Worcester, Massachusetts, Förenta staterna, 01605
- University of Massachusetts Memorial Health Care
-
-
Michigan
-
Detroit, Michigan, Förenta staterna, 48201
- Wayne State University/Karmanos Cancer Institute
-
Escanaba, Michigan, Förenta staterna, 49829
- Green Bay Oncology - Escanaba
-
Grand Rapids, Michigan, Förenta staterna, 49503
- Spectrum Health at Butterworth Campus
-
Iron Mountain, Michigan, Förenta staterna, 49801
- Green Bay Oncology - Iron Mountain
-
Kalamazoo, Michigan, Förenta staterna, 49007
- West Michigan Cancer Center
-
Kalamazoo, Michigan, Förenta staterna, 49007
- Bronson Methodist Hospital
-
Kalamazoo, Michigan, Förenta staterna, 49048
- Borgess Medical Center
-
Niles, Michigan, Förenta staterna, 49120
- Lakeland Hospital Niles
-
Royal Oak, Michigan, Förenta staterna, 48073
- William Beaumont Hospital-Royal Oak
-
Saint Joseph, Michigan, Förenta staterna, 49085
- Lakeland Medical Center Saint Joseph
-
Saint Joseph, Michigan, Förenta staterna, 49085
- Marie Yeager Cancer Center
-
-
Minnesota
-
Burnsville, Minnesota, Förenta staterna, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, Förenta staterna, 55433
- Mercy Hospital
-
Edina, Minnesota, Förenta staterna, 55435
- Fairview-Southdale Hospital
-
Fridley, Minnesota, Förenta staterna, 55432
- Unity Hospital
-
Hutchinson, Minnesota, Förenta staterna, 55350
- Hutchinson Area Health Care
-
Maplewood, Minnesota, Förenta staterna, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, Förenta staterna, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, Förenta staterna, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, Förenta staterna, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, Förenta staterna, 55455
- University of Minnesota/Masonic Cancer Center
-
New Ulm, Minnesota, Förenta staterna, 56073
- New Ulm Medical Center
-
Robbinsdale, Minnesota, Förenta staterna, 55422
- North Memorial Medical Health Center
-
Saint Louis Park, Minnesota, Förenta staterna, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Louis Park, Minnesota, Förenta staterna, 55416
- Metro Minnesota Community Oncology Research Consortium
-
Saint Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital
-
Saint Paul, Minnesota, Förenta staterna, 55102
- United Hospital
-
Shakopee, Minnesota, Förenta staterna, 55379
- Saint Francis Regional Medical Center
-
Stillwater, Minnesota, Förenta staterna, 55082
- Lakeview Hospital
-
Waconia, Minnesota, Förenta staterna, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, Förenta staterna, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, Förenta staterna, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
-
Missouri
-
Kansas City, Missouri, Förenta staterna, 64116
- North Kansas City Hospital
-
Kansas City, Missouri, Förenta staterna, 64111
- Saint Luke's Hospital of Kansas City
-
Kansas City, Missouri, Förenta staterna, 64132
- Research Medical Center
-
Kansas City, Missouri, Förenta staterna, 64108
- Truman Medical Center
-
Kansas City, Missouri, Förenta staterna, 64118
- Heartland Hematology and Oncology Associates Incorporated
-
Kansas City, Missouri, Förenta staterna, 64114
- Saint Joseph Health Center
-
Lee's Summit, Missouri, Förenta staterna, 64086
- Saint Luke's East - Lee's Summit
-
Liberty, Missouri, Förenta staterna, 64068
- Liberty Radiation Oncology Center
-
Saint Joseph, Missouri, Förenta staterna, 64507
- Saint Joseph Oncology Inc
-
Saint Joseph, Missouri, Förenta staterna, 64507
- Heartland Regional Medical Center
-
Saint Louis, Missouri, Förenta staterna, 63110
- Washington University School of Medicine
-
Springfield, Missouri, Förenta staterna, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, Förenta staterna, 65804
- Mercy Hospital Springfield
-
-
Montana
-
Billings, Montana, Förenta staterna, 59101
- Billings Clinic Cancer Center
-
-
Nebraska
-
Omaha, Nebraska, Förenta staterna, 68114
- Nebraska Methodist Hospital
-
Omaha, Nebraska, Förenta staterna, 68198
- University of Nebraska Medical Center
-
-
New Mexico
-
Albuquerque, New Mexico, Förenta staterna, 87102
- University of New Mexico Cancer Center
-
Albuquerque, New Mexico, Förenta staterna, 87106
- Southwest Gynecologic Oncology Associates Inc
-
Las Cruces, New Mexico, Förenta staterna, 88011
- Memorial Medical Center - Las Cruces
-
-
New York
-
Brightwaters, New York, Förenta staterna, 11718
- Island Gynecologic Oncology
-
-
Ohio
-
Akron, Ohio, Förenta staterna, 44307
- Cleveland Clinic Akron General
-
Akron, Ohio, Förenta staterna, 44304
- Summa Akron City Hospital/Cooper Cancer Center
-
Cleveland, Ohio, Förenta staterna, 44106
- Case Western Reserve University
-
Cleveland, Ohio, Förenta staterna, 44109
- MetroHealth Medical Center
-
Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Förenta staterna, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital
-
Columbus, Ohio, Förenta staterna, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, Förenta staterna, 43210
- Ohio State University Comprehensive Cancer Center
-
Dayton, Ohio, Förenta staterna, 45409
- Miami Valley Hospital
-
Mayfield Heights, Ohio, Förenta staterna, 44124
- Hillcrest Hospital Cancer Center
-
Mentor, Ohio, Förenta staterna, 44060
- UH Seidman Cancer Center at Lake Health Mentor Campus
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Förenta staterna, 73104
- University of Oklahoma Health Sciences Center
-
Tulsa, Oklahoma, Förenta staterna, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
-
-
Pennsylvania
-
Abington, Pennsylvania, Förenta staterna, 19001
- Abington Memorial Hospital
-
Allentown, Pennsylvania, Förenta staterna, 18103
- Lehigh Valley Hospital-Cedar Crest
-
Bryn Mawr, Pennsylvania, Förenta staterna, 19010
- Bryn Mawr Hospital
-
Paoli, Pennsylvania, Förenta staterna, 19301
- Paoli Memorial Hospital
-
Pittsburgh, Pennsylvania, Förenta staterna, 15224
- West Penn Hospital
-
Pittsburgh, Pennsylvania, Förenta staterna, 15213
- UPMC-Magee Womens Hospital
-
Pittsburgh, Pennsylvania, Förenta staterna, 15232
- University of Pittsburgh Cancer Institute (UPCI)
-
Wynnewood, Pennsylvania, Förenta staterna, 19096
- Lankenau Medical Center
-
Wynnewood, Pennsylvania, Förenta staterna, 19096
- Main Line Health NCORP
-
-
Rhode Island
-
Providence, Rhode Island, Förenta staterna, 02905
- Women and Infants Hospital
-
-
South Carolina
-
Charleston, South Carolina, Förenta staterna, 29425
- Medical University of South Carolina
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- The Methodist Hospital System
-
-
Virginia
-
Richmond, Virginia, Förenta staterna, 23298
- Virginia Commonwealth University/Massey Cancer Center
-
-
Wisconsin
-
Eau Claire, Wisconsin, Förenta staterna, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
-
Green Bay, Wisconsin, Förenta staterna, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, Förenta staterna, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Green Bay, Wisconsin, Förenta staterna, 54303
- Green Bay Oncology Limited at Saint Mary's Hospital
-
Green Bay, Wisconsin, Förenta staterna, 54301-3526
- Green Bay Oncology at Saint Vincent Hospital
-
Madison, Wisconsin, Förenta staterna, 53792
- University of Wisconsin Hospital and Clinics
-
Manitowoc, Wisconsin, Förenta staterna, 54221
- Holy Family Memorial Hospital
-
Marinette, Wisconsin, Förenta staterna, 54143
- Bay Area Medical Center
-
Marshfield, Wisconsin, Förenta staterna, 54449
- Marshfield Medical Center-Marshfield
-
Milwaukee, Wisconsin, Förenta staterna, 53215
- Aurora Saint Luke's Medical Center
-
Minocqua, Wisconsin, Förenta staterna, 54548
- Marshfield Clinic-Minocqua Center
-
Oconto Falls, Wisconsin, Förenta staterna, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Rice Lake, Wisconsin, Förenta staterna, 54868
- Marshfield Medical Center-Rice Lake
-
Sturgeon Bay, Wisconsin, Förenta staterna, 54235
- Green Bay Oncology - Sturgeon Bay
-
West Allis, Wisconsin, Förenta staterna, 53227
- Aurora West Allis Medical Center
-
Weston, Wisconsin, Förenta staterna, 54476
- Marshfield Clinic - Weston Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
Sidostudier
Andra namn:
Sidostudier
Sidostudier
Andra namn:
Ancillary studies
Ancillary studies
Andra namn:
Ancillary studies
|
Experimentell: 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.
|
Sidostudier
Andra namn:
Sidostudier
Sidostudier
Andra namn:
Ancillary studies
Andra namn:
Ancillary studies
|
Aktiv 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.
|
Sidostudier
Andra namn:
Sidostudier
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Symptom severity, symptom-related distress, consequences, and control of symptoms as measured by the Symptom Representation Questionnaire
Tidsram: Baseline and at 4, 8, and 12 weeks
|
Baseline and at 4, 8, and 12 weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Health-related quality of life as measured by the FACT-O
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline and at 4, 8, and 12 weeks
|
Baseline and at 4, 8, and 12 weeks
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Heidi Donovan, Gynecologic Oncology Group
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GOG-0259 (Annan identifierare: CTEP)
- U10CA101165 (U.S.S. NIH-anslag/kontrakt)
- NCI-2011-01950 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- CDR0000648729
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Assistance Publique - Hôpitaux de ParisAktiv, inte rekryterandeOkomplicerad Tubo Ovarian AbscessFrankrike
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Elizabeth K. Lee MDMerck Sharp & Dohme LLCRekryteringGynekologisk cancer | Ovarian clear cell carcinomaFörenta staterna
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Children's Oncology GroupNational Cancer Institute (NCI)RekryteringMalign könscellstumör | Könscellstumör | Barndom extrakraniell könscellstumör | Extragonadalt embryonalt karcinom | Malignt ovarieteratom | Steg I Ovarian Choriocarcinoma | Steg I Ovarian Embryonal Carcinom AJCC v6 och v7 | Steg I Ovarian Teratoma AJCC v6 och v7 | Steg I Äggäggulasäcktumör AJCC v6 och v7 | Steg I testikelkoriokarcinom AJCC v6 och... och andra villkorFörenta staterna, Kanada, Japan, Australien, Puerto Rico, Nya Zeeland, Saudiarabien, Storbritannien, Indien
Kliniska prövningar på Livskvalitetsbedömning
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Memorial Sloan Kettering Cancer CenterAvslutadAscitesFörenta staterna
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Latin American Cooperative Oncology GroupRoche Pharma AG; EVA - Grupo Brasileiro de Tumores GinecológicosAvslutadLivmoderhalscancerBrasilien
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CelgeneAvslutadMyelodysplastiska syndrom | Multipelt myelom | Leukemi Myeloid Akut | Leuklemi, lymfocytisk, kroniskSpanien
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Tanta UniversityRekryteringLivskvalité | Malocklusion | Korsbett | TalEgypten
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Maastricht UniversityTNO; Netherlands Instititute for Health Services Research; University of...AvslutadHjärtsvikt | Diabetes mellitus, typ 2 | Kronisk obstruktiv lungsjukdom | AstmaNederländerna
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World Vision CanadaRyerson University; World Health Organization; Global Affairs Canada; Ministry...AvslutadDiarre | Malaria | Akut luftvägsinfektion
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Fatih Sultan Mehmet Training and Research HospitalAktiv, inte rekryterande
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University Hospital, Strasbourg, FranceAvslutadKirurgiskt ingrepp | MindreFrankrike
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King's College LondonGuy's and St Thomas' NHS Foundation TrustAvslutad
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Federal University of Minas GeraisConselho Nacional de Desenvolvimento Científico e TecnológicoOkändDepression | Muskelsjukdomar | Värmevallningar | Ångest | Premenstruell spänningBrasilien