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

8 mars 2019 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

485

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: Évaluation de la qualité de vie
Etudes annexes
Autres noms:
  • Évaluation de la qualité de vie
Autre: Gestion des questionnaires
Etudes annexes
Procédure: Évaluation et soins psychosociaux
Etudes annexes
Autres noms:
  • Soins psychosociaux/évaluation
Autre: Communication Intervention
Ancillary studies
Autre: Educational Intervention
Ancillary studies
Autres noms:
  • Éducation à l'intervention
  • Intervention par l'éducation
  • Intervention, Éducatif
Autre: Internet-Based Intervention
Ancillary studies
Expérimental: 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.
Autre: Évaluation de la qualité de vie
Etudes annexes
Autres noms:
  • Évaluation de la qualité de vie
Autre: Gestion des questionnaires
Etudes annexes
Procédure: Évaluation et soins psychosociaux
Etudes annexes
Autres noms:
  • Soins psychosociaux/évaluation
Autre: Educational Intervention
Ancillary studies
Autres noms:
  • Éducation à l'intervention
  • Intervention par l'éducation
  • Intervention, Éducatif
Autre: Internet-Based Intervention
Ancillary studies
Comparateur actif: 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.
Autre: Évaluation de la qualité de vie
Etudes annexes
Autres noms:
  • Évaluation de la qualité de vie
Autre: Gestion des questionnaires
Etudes annexes

Que mesure l'étude ?

Principaux critères de jugement

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

Mesures de résultats secondaires

Mesure des résultats
Délai
Health-related quality of life as measured by the FACT-O
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline and at 4, 8, and 12 weeks
Baseline and at 4, 8, and 12 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Gynecologic Oncology Group

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Heidi Donovan, Gynecologic Oncology Group

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

19 janvier 2010

Achèvement primaire (Réel)

8 janvier 2017

Dates d'inscription aux études

Première soumission

12 août 2009

Première soumission répondant aux critères de contrôle qualité

12 août 2009

Première publication (Estimation)

13 août 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 mars 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 mars 2019

Dernière vérification

1 mars 2019

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • GOG-0259 (Autre identifiant: CTEP)
  • U10CA101165 (Subvention/contrat des NIH des États-Unis)
  • NCI-2011-01950 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • CDR0000648729

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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