Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Symptom Management in Patients With Recurrent or Persistent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

8. mars 2019 oppdatert av: Gynecologic Oncology Group

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

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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

485

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85012
        • Gynecologic Oncology Group of Arizona
    • California
      • Los Angeles, California, Forente stater, 90095
        • UCLA / Jonsson Comprehensive Cancer Center
      • Los Angeles, California, Forente stater, 90048
        • Cedars Sinai Medical Center
      • Mountain View, California, Forente stater, 94040
        • Palo Alto Medical Foundation-Gynecologic Oncology
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • University Of Colorado Hospital
    • Connecticut
      • Hartford, Connecticut, Forente stater, 06102
        • Hartford Hospital
      • New Britain, Connecticut, Forente stater, 06050
        • The Hospital of Central Connecticut
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, Forente stater, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, Forente stater, 96826
        • Kapiolani Medical Center for Women and Children
    • Illinois
      • Decatur, Illinois, Forente stater, 62526
        • Decatur Memorial Hospital
      • Springfield, Illinois, Forente stater, 62781
        • Memorial Medical Center
      • Urbana, Illinois, Forente stater, 61801
        • Carle Cancer Center
    • Indiana
      • Elkhart, Indiana, Forente stater, 46515
        • Elkhart General Hospital
      • Elkhart, Indiana, Forente stater, 46514
        • Michiana Hematology Oncology PC-Elkhart
      • Elkhart, Indiana, Forente stater, 46514-2098
        • Elkhart Clinic
      • Indianapolis, Indiana, Forente stater, 46202
        • Indiana University/Melvin and Bren Simon Cancer Center
      • Kokomo, Indiana, Forente stater, 46904
        • Community Howard Regional Health
      • La Porte, Indiana, Forente stater, 46350
        • IU Health La Porte Hospital
      • Mishawaka, Indiana, Forente stater, 46545
        • Michiana Hematology Oncology PC-Mishawaka
      • Mishawaka, Indiana, Forente stater, 46545
        • Saint Joseph Regional Medical Center-Mishawaka
      • Plymouth, Indiana, Forente stater, 46563
        • Michiana Hematology Oncology PC-Plymouth
      • South Bend, Indiana, Forente stater, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Forente stater, 46601
        • Michiana Hematology Oncology PC-South Bend
      • South Bend, Indiana, Forente stater, 46628
        • Northern Indiana Cancer Research Consortium
      • South Bend, Indiana, Forente stater, 46617
        • South Bend Clinic
      • Westville, Indiana, Forente stater, 46391
        • Michiana Hematology Oncology PC-Westville
    • Iowa
      • Clive, Iowa, Forente stater, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, Forente stater, 50325
        • Medical Oncology and Hematology Associates-West Des Moines
      • Des Moines, Iowa, Forente stater, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Forente stater, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Forente stater, 50309
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines, Iowa, Forente stater, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, Forente stater, 50309
        • Iowa-Wide Oncology Research Coalition NCORP
      • Des Moines, Iowa, Forente stater, 50314
        • Medical Oncology and Hematology Associates-Laurel
      • Iowa City, Iowa, Forente stater, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • West Des Moines, Iowa, Forente stater, 50266-7700
        • Methodist West Hospital
      • West Des Moines, Iowa, Forente stater, 50266
        • Mercy Medical Center-West Lakes
    • Kansas
      • Kansas City, Kansas, Forente stater, 66112
        • Providence Medical Center
      • Overland Park, Kansas, Forente stater, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, Forente stater, 66213
        • Saint Luke's South Hospital
      • Prairie Village, Kansas, Forente stater, 66208
        • Kansas City NCI Community Oncology Research Program
      • Shawnee Mission, Kansas, Forente stater, 66204
        • Shawnee Mission Medical Center-KCCC
    • Louisiana
      • Shreveport, Louisiana, Forente stater, 71105
        • CHRISTUS Highland Medical Center
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
      • Bethesda, Maryland, Forente stater, 20889-5600
        • Walter Reed National Military Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Forente stater, 02114
        • Massachusetts General Hospital Cancer Center
      • Worcester, Massachusetts, Forente stater, 01655
        • University of Massachusetts Medical School
      • Worcester, Massachusetts, Forente stater, 01605
        • University of Massachusetts Memorial Health Care
    • Michigan
      • Detroit, Michigan, Forente stater, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Escanaba, Michigan, Forente stater, 49829
        • Green Bay Oncology - Escanaba
      • Grand Rapids, Michigan, Forente stater, 49503
        • Spectrum Health at Butterworth Campus
      • Iron Mountain, Michigan, Forente stater, 49801
        • Green Bay Oncology - Iron Mountain
      • Kalamazoo, Michigan, Forente stater, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, Forente stater, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Forente stater, 49048
        • Borgess Medical Center
      • Niles, Michigan, Forente stater, 49120
        • Lakeland Hospital Niles
      • Royal Oak, Michigan, Forente stater, 48073
        • William Beaumont Hospital-Royal Oak
      • Saint Joseph, Michigan, Forente stater, 49085
        • Lakeland Medical Center Saint Joseph
      • Saint Joseph, Michigan, Forente stater, 49085
        • Marie Yeager Cancer Center
    • Minnesota
      • Burnsville, Minnesota, Forente stater, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Forente stater, 55433
        • Mercy Hospital
      • Edina, Minnesota, Forente stater, 55435
        • Fairview-Southdale Hospital
      • Fridley, Minnesota, Forente stater, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, Forente stater, 55350
        • Hutchinson Area Health Care
      • Maplewood, Minnesota, Forente stater, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, Forente stater, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, Forente stater, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Forente stater, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, Forente stater, 55455
        • University of Minnesota/Masonic Cancer Center
      • New Ulm, Minnesota, Forente stater, 56073
        • New Ulm Medical Center
      • Robbinsdale, Minnesota, Forente stater, 55422
        • North Memorial Medical Health Center
      • Saint Louis Park, Minnesota, Forente stater, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, Forente stater, 55416
        • Metro Minnesota Community Oncology Research Consortium
      • Saint Paul, Minnesota, Forente stater, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Forente stater, 55102
        • United Hospital
      • Shakopee, Minnesota, Forente stater, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, Forente stater, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, Forente stater, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, Forente stater, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, Forente stater, 55125
        • Minnesota Oncology Hematology PA-Woodbury
    • Missouri
      • Kansas City, Missouri, Forente stater, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, Forente stater, 64111
        • Saint Luke's Hospital of Kansas City
      • Kansas City, Missouri, Forente stater, 64132
        • Research Medical Center
      • Kansas City, Missouri, Forente stater, 64108
        • Truman Medical Center
      • Kansas City, Missouri, Forente stater, 64118
        • Heartland Hematology and Oncology Associates Incorporated
      • Kansas City, Missouri, Forente stater, 64114
        • Saint Joseph Health Center
      • Lee's Summit, Missouri, Forente stater, 64086
        • Saint Luke's East - Lee's Summit
      • Liberty, Missouri, Forente stater, 64068
        • Liberty Radiation Oncology Center
      • Saint Joseph, Missouri, Forente stater, 64507
        • Saint Joseph Oncology Inc
      • Saint Joseph, Missouri, Forente stater, 64507
        • Heartland Regional Medical Center
      • Saint Louis, Missouri, Forente stater, 63110
        • Washington University School of Medicine
      • Springfield, Missouri, Forente stater, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Forente stater, 65804
        • Mercy Hospital Springfield
    • Montana
      • Billings, Montana, Forente stater, 59101
        • Billings Clinic Cancer Center
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, Forente stater, 68198
        • University of Nebraska Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87102
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, Forente stater, 87106
        • Southwest Gynecologic Oncology Associates Inc
      • Las Cruces, New Mexico, Forente stater, 88011
        • Memorial Medical Center - Las Cruces
    • New York
      • Brightwaters, New York, Forente stater, 11718
        • Island Gynecologic Oncology
    • Ohio
      • Akron, Ohio, Forente stater, 44307
        • Cleveland Clinic Akron General
      • Akron, Ohio, Forente stater, 44304
        • Summa Akron City Hospital/Cooper Cancer Center
      • Cleveland, Ohio, Forente stater, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, Forente stater, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, Forente stater, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, Forente stater, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, Forente stater, 43210
        • Ohio State University Comprehensive Cancer Center
      • Dayton, Ohio, Forente stater, 45409
        • Miami Valley Hospital
      • Mayfield Heights, Ohio, Forente stater, 44124
        • Hillcrest Hospital Cancer Center
      • Mentor, Ohio, Forente stater, 44060
        • UH Seidman Cancer Center at Lake Health Mentor Campus
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, Forente stater, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Pennsylvania
      • Abington, Pennsylvania, Forente stater, 19001
        • Abington Memorial Hospital
      • Allentown, Pennsylvania, Forente stater, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bryn Mawr, Pennsylvania, Forente stater, 19010
        • Bryn Mawr Hospital
      • Paoli, Pennsylvania, Forente stater, 19301
        • Paoli Memorial Hospital
      • Pittsburgh, Pennsylvania, Forente stater, 15224
        • West Penn Hospital
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • UPMC-Magee Womens Hospital
      • Pittsburgh, Pennsylvania, Forente stater, 15232
        • University of Pittsburgh Cancer Institute (UPCI)
      • Wynnewood, Pennsylvania, Forente stater, 19096
        • Lankenau Medical Center
      • Wynnewood, Pennsylvania, Forente stater, 19096
        • Main Line Health NCORP
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02905
        • Women and Infants Hospital
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Medical University of South Carolina
    • Texas
      • Houston, Texas, Forente stater, 77030
        • The Methodist Hospital System
    • Virginia
      • Richmond, Virginia, Forente stater, 23298
        • Virginia Commonwealth University/Massey Cancer Center
    • Wisconsin
      • Eau Claire, Wisconsin, Forente stater, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Green Bay, Wisconsin, Forente stater, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, Forente stater, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • Green Bay, Wisconsin, Forente stater, 54303
        • Green Bay Oncology Limited at Saint Mary's Hospital
      • Green Bay, Wisconsin, Forente stater, 54301-3526
        • Green Bay Oncology at Saint Vincent Hospital
      • Madison, Wisconsin, Forente stater, 53792
        • University of Wisconsin Hospital and Clinics
      • Manitowoc, Wisconsin, Forente stater, 54221
        • Holy Family Memorial Hospital
      • Marinette, Wisconsin, Forente stater, 54143
        • Bay Area Medical Center
      • Marshfield, Wisconsin, Forente stater, 54449
        • Marshfield Medical Center-Marshfield
      • Milwaukee, Wisconsin, Forente stater, 53215
        • Aurora Saint Luke's Medical Center
      • Minocqua, Wisconsin, Forente stater, 54548
        • Marshfield Clinic-Minocqua Center
      • Oconto Falls, Wisconsin, Forente stater, 54154
        • Saint Vincent Hospital Cancer Center at Oconto Falls
      • Rice Lake, Wisconsin, Forente stater, 54868
        • Marshfield Medical Center-Rice Lake
      • Sturgeon Bay, Wisconsin, Forente stater, 54235
        • Green Bay Oncology - Sturgeon Bay
      • West Allis, Wisconsin, Forente stater, 53227
        • Aurora West Allis Medical Center
      • Weston, Wisconsin, Forente stater, 54476
        • Marshfield Clinic - Weston Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: Livskvalitetsvurdering
Hjelpestudier
Andre navn:
  • Livskvalitetsvurdering
Annen: Spørreskjemaadministrasjon
Hjelpestudier
Fremgangsmåte: Psykososial vurdering og omsorg
Hjelpestudier
Andre navn:
  • Psykososial omsorg/vurdering
Annen: Communication Intervention
Ancillary studies
Annen: Educational Intervention
Ancillary studies
Andre navn:
  • Utdanning for intervensjon
  • Intervensjon fra utdanning
  • Intervensjon gjennom utdanning
  • Intervensjon, pedagogisk
Annen: Internet-Based Intervention
Ancillary studies
Eksperimentell: 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.
Annen: Livskvalitetsvurdering
Hjelpestudier
Andre navn:
  • Livskvalitetsvurdering
Annen: Spørreskjemaadministrasjon
Hjelpestudier
Fremgangsmåte: Psykososial vurdering og omsorg
Hjelpestudier
Andre navn:
  • Psykososial omsorg/vurdering
Annen: Educational Intervention
Ancillary studies
Andre navn:
  • Utdanning for intervensjon
  • Intervensjon fra utdanning
  • Intervensjon gjennom utdanning
  • Intervensjon, pedagogisk
Annen: Internet-Based Intervention
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.
Annen: Livskvalitetsvurdering
Hjelpestudier
Andre navn:
  • Livskvalitetsvurdering
Annen: Spørreskjemaadministrasjon
Hjelpestudier

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Symptom severity, symptom-related distress, consequences, and control of symptoms as measured by the Symptom Representation Questionnaire
Tidsramme: Baseline and at 4, 8, and 12 weeks
Baseline and at 4, 8, and 12 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Health-related quality of life as measured by the FACT-O
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and at 4, 8, and 12 weeks
Baseline and at 4, 8, and 12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Gynecologic Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Heidi Donovan, Gynecologic Oncology Group

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. januar 2010

Primær fullføring (Faktiske)

8. januar 2017

Datoer for studieregistrering

Først innsendt

12. august 2009

Først innsendt som oppfylte QC-kriteriene

12. august 2009

Først lagt ut (Anslag)

13. august 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. mars 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. mars 2019

Sist bekreftet

1. mars 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GOG-0259 (Annen identifikator: CTEP)
  • U10CA101165 (U.S. NIH-stipend/kontrakt)
  • NCI-2011-01950 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • CDR0000648729

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere