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Collection of Patient-Reported Symptoms and Performance Status Via the Internet

26. juni 2017 opdateret af: Alliance for Clinical Trials in Oncology
This pilot clinical trial studies how well using the internet to collect symptoms and the ability to carry out daily activities works in patients with enrolled on Cancer and Leukemia Group B (CALGB) studies. A study that evaluates a patient's ability to use a clinic waiting room computer to report their symptoms and their ability to carry out daily activities may help doctors understand a patient's use of a computer to report symptoms.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study enrolled participants who were diagnosed with breast cancer, lung cancer, colorectal cancer, leukemia and multiple myeloma and prostate cancer.

PRIMARY OBJECTIVES:

I. To assess the feasibility of collecting symptom data directly from patients at clinic visits via waiting-area computers.

II. To preliminarily assess the level of agreement between patient and clinician Common Terminology Criteria for Adverse Events (CTCAE) symptom severity scoring, and to measure whether their scores converge when clinicians are exposed to patient self-reports.

OUTLINE:

Patients are registered into the Symptom Tracking and Reporting (STAR) database, obtain a password, undergo STAR training, and complete a patient-STAR questionnaire after seeing their clinician (baseline self-report) on day 1 of course 2* of chemotherapy. Patients are reminded to complete online STAR questionnaire before seeing their clinician on day 1 of courses 3, 4, 5, and 6* of chemotherapy. Clinicians review these patient reports before creating their own assessment. Patients also complete a patient feedback survey on day 1 of course 4* of chemotherapy. Clinicians complete feedback survey at study completion.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

325

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Castro Valley, California, Forenede Stater, 94546
        • East Bay Radiation Oncology Center
      • Castro Valley, California, Forenede Stater, 94546
        • Valley Medical Oncology Consultants - Castro Valley
      • Fremont, California, Forenede Stater, 94538
        • Valley Medical Oncology
      • Martinez, California, Forenede Stater, 94553-3156
        • Contra Costa Regional Medical Center
      • Mountain View, California, Forenede Stater, 94040
        • El Camino Hospital Cancer Center
      • Oakland, California, Forenede Stater, 94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, Forenede Stater, 94602
        • Highland General Hospital
      • Oakland, California, Forenede Stater, 94609
        • Larry G Strieff MD Medical Corporation
      • Oakland, California, Forenede Stater, 94609
        • CCOP - Bay Area Tumor Institute
      • Oakland, California, Forenede Stater, 94609
        • Bay Area Breast Surgeons, Incorporated
      • Oakland, California, Forenede Stater, 94609
        • Tom K Lee, Incorporated
      • San Francisco, California, Forenede Stater, 94115
        • UCSF Helen Diller Family Comprehensive Cancer Center
      • San Pablo, California, Forenede Stater, 94806
        • Doctors Medical Center - San Pablo Campus
    • Delaware
      • Lewes, Delaware, Forenede Stater, 19958
        • Tunnell Cancer Center at Beebe Medical Center
      • Newark, Delaware, Forenede Stater, 19713
        • CCOP - Christiana Care Health Services
    • Florida
      • Orlando, Florida, Forenede Stater, 32803-1273
        • Florida Hospital Cancer Institute at Florida Hospital Orlando
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Forenede Stater, 60640
        • Louis A. Weiss Memorial Hospital
      • La Grange, Illinois, Forenede Stater, 60525
        • La Grange Memorial Hospital
      • Rockford, Illinois, Forenede Stater, 61108
        • Center for Cancer Care at OSF Saint Anthony Medical Center
    • Indiana
      • Elkhart, Indiana, Forenede Stater, 46515
        • Elkhart General Hospital
      • Elkhart, Indiana, Forenede Stater, 46514-2098
        • Elkhart Clinic, LLC
      • Elkhart, Indiana, Forenede Stater, 46514
        • Michiana Hematology-Oncology, PC - Elkhart
      • Kokomo, Indiana, Forenede Stater, 46904
        • Howard Community Hospital
      • La Porte, Indiana, Forenede Stater, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Mishawaka, Indiana, Forenede Stater, 46545-1470
        • Michiana Hematology-Oncology, PC - South Bend
      • Mishawaka, Indiana, Forenede Stater, 46545-1470
        • Saint Joseph Regional Medical Center
      • Plymouth, Indiana, Forenede Stater, 46563
        • Michiana Hematology Oncology PC - Plymouth
      • South Bend, Indiana, Forenede Stater, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Forenede Stater, 46601
        • CCOP - Northern Indiana CR Consortium
      • Westville, Indiana, Forenede Stater, 46391
        • Michiana Hematology Oncology PC - La Porte
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
      • Iowa City, Iowa, Forenede Stater, 52246
        • Veterans Affairs Medical Center - Iowa City
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, Forenede Stater, 66213
        • Saint Luke's Hospital - South
      • Prairie Village, Kansas, Forenede Stater, 66208
        • CCOP - Kansas City
    • Maine
      • Bangor, Maine, Forenede Stater, 04401
        • CancerCare of Maine at Eastern Maine Medical Center
    • Maryland
      • Elkton, Maryland, Forenede Stater, 21921
        • Union Hospital of Cecil County
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana-Farber/Brigham and Women's Cancer Center
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
    • Michigan
      • Niles, Michigan, Forenede Stater, 49120
        • Michiana Hematology Oncology PC - Niles
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Lakeside Cancer Specialists, PLLC
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Lakeland Regional Cancer Care Center - St. Joseph
    • Missouri
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • Southeast Cancer Center
      • Jefferson City, Missouri, Forenede Stater, 65109
        • Goldschmidt Cancer Center
      • Kansas City, Missouri, Forenede Stater, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, Forenede Stater, 64132
        • Research Medical Center
      • Kansas City, Missouri, Forenede Stater, 64108
        • Truman Medical Center - Hospital Hill
      • Kansas City, Missouri, Forenede Stater, 64111
        • Saint Luke's Cancer Institute at Saint Luke's Hospital
      • Kansas City, Missouri, Forenede Stater, 64114
        • St. Joseph Medical Center
      • Kansas City, Missouri, Forenede Stater, 64116
        • Parvin Radiation Oncology
      • Lee's Summit, Missouri, Forenede Stater, 64086
        • Saint Luke's East - Lee's Summit
      • Liberty, Missouri, Forenede Stater, 64068
        • Liberty Hospital
      • Saint Joseph, Missouri, Forenede Stater, 64506
        • Heartland Regional Medical Center
      • Saint Louis, Missouri, Forenede Stater, 63131
        • Missouri Baptist Cancer Center
      • Saint Louis, Missouri, Forenede Stater, 63141
        • Comprehensive Cancer Care, PC
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • CCOP - Nevada Cancer Research Foundation
    • New Hampshire
      • Concord, New Hampshire, Forenede Stater, 03301
        • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
      • Hooksett, New Hampshire, Forenede Stater, 03106
        • New Hampshire Oncology - Hematology, PA - Hooksett
      • Laconia, New Hampshire, Forenede Stater, 03246
        • Lakes Region General Hospital
      • Lebanon, New Hampshire, Forenede Stater, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
      • Manchester, New Hampshire, Forenede Stater, 03102
        • Norris Cotton Cancer Center at Catholic Medical Center
    • New Jersey
      • Voorhees, New Jersey, Forenede Stater, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New York
      • East Syracuse, New York, Forenede Stater, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
      • Elmhurst, New York, Forenede Stater, 11373
        • Elmhurst Hospital Center
      • Jamaica, New York, Forenede Stater, 11432
        • Queens Cancer Center of Queens Hospital
      • Lake Success, New York, Forenede Stater, 11042
        • Monter Cancer Center of the North Shore-LIJ Health System
      • Manhasset, New York, Forenede Stater, 11030
        • CCOP - North Shore University Hospital
      • Manhasset, New York, Forenede Stater, 11030
        • Don Monti Comprehensive Cancer Center at North Shore University Hospital
      • New Hyde Park, New York, Forenede Stater, 11040
        • Long Island Jewish Medical Center
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan-Kettering Cancer Center
      • Syracuse, New York, Forenede Stater, 13210
        • Veterans Affairs Medical Center - Syracuse
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28801
        • Mission Hospitals - Memorial Campus
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Comprehensive Cancer Center
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Wayne Memorial Hospital, Incorporated
      • Pinehurst, North Carolina, Forenede Stater, 28374
        • FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
      • Statesville, North Carolina, Forenede Stater, 28677
        • Iredell Memorial Hospital
      • Winston-Salem, North Carolina, Forenede Stater, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02906
        • Miriam Hospital
      • Providence, Rhode Island, Forenede Stater, 02903
        • Rhode Island Hospital Comprehensive Cancer Center
    • South Carolina
      • Easley, South Carolina, Forenede Stater, 29640
        • Cancer Centers of the Carolinas - Easley
      • Greenville, South Carolina, Forenede Stater, 29615
        • CCOP - Greenville
      • Greenville, South Carolina, Forenede Stater, 29605
        • Greenville Hospital Cancer Center
      • Greenville, South Carolina, Forenede Stater, 29605
        • Cancer Centers of the Carolinas - Faris Road
      • Greenville, South Carolina, Forenede Stater, 29605
        • Cancer Centers of the Carolinas - Grove Commons
      • Greenville, South Carolina, Forenede Stater, 29601
        • Bon Secours St. Francis Health System
      • Greenwood, South Carolina, Forenede Stater, 29646
        • Self Regional Cancer Center at Self Regional Medical Center
      • Greer, South Carolina, Forenede Stater, 29650
        • Cancer Centers of the Carolinas - Greer Medical Oncology
      • Seneca, South Carolina, Forenede Stater, 29672
        • Cancer Centers of the Carolinas - Seneca
      • Spartanburg, South Carolina, Forenede Stater, 29307
        • Cancer Centers of the Carolinas - Spartanburg
    • Vermont
      • Berlin Corners, Vermont, Forenede Stater, 05602
        • Mountainview Medical
      • Burlington, Vermont, Forenede Stater, 05401
        • Fletcher Allen Health Care - University Health Center Campus

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Enrolled on clinical trial CALGB-90401, CALGB-30607, CALGB-30704, CALGB-40601, CALGB-40603, CALGB-40502, CALGB-40503, CALGB-70604, or CALGB-80405

PATIENT CHARACTERISTICS:

  • Able to read and comprehend English language text
  • Able to see a computer screen (i.e., no visual impairments) or be accompanied at visits by someone who can read the screen for the patient

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: (Internet-based STAR database)

Patients are registered into the STAR database, obtain a password, undergo STAR training, and complete a patient-STAR questionnaire after seeing their clinician (baseline self-report) on day 1 of course 2* of chemotherapy. Patients are reminded to complete online STAR questionnaire before seeing their clinician on day 1 of courses 3, 4, 5, and 6* of chemotherapy. Clinicians review these patient reports before creating their own assessment. Patients also complete a patient feedback survey on day 1 of course 4* of chemotherapy. Clinicians complete feedback survey at study completion.

NOTE: *All time points are based on scheduled therapy with clinical trial CALGB-90401, CALGB-30607, CALGB-30704, CALGB-40601, CALGB-40603, CALGB-40502, CALGB-70604, CALGB-80405, or CALGB-40503.
Andet: Spørgeskemaadministration
Hjælpestudier
Andet: internet-based intervention
Use the STAR database system
Andet: assessment of therapy complications
Use the STAR database system

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Willingness of approached patients to participate in this study this study
Tidsramme: Up to 6 years
Up to 6 years
Proportion of enrolled patients who submit an online questionnaire at any given follow-up visit any given follow-up visit
Tidsramme: Up to 16 weeks
Up to 16 weeks
Proportion of total attended visits during the study period at which a questionnaire was completed (completers:visits) which a questionnaire was completed (completers:visits)
Tidsramme: Up to 15 weeks
Up to 15 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Patient-reported CTCAE symptoms using symptom severity data
Tidsramme: At baseline (day 22)
At baseline (day 22)
Clinician-reported CTCAE symptoms using symptom severity data clinician reporting at day 43 (when patients report before clinicians; clinicians view those reports) vs at day 22 (patients report symptoms after the clinical encounter)
Tidsramme: At baseline (day 22)
At baseline (day 22)
Mean severity scores for patient reporting at day 43
Tidsramme: Up to day 43
Up to day 43

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Ethan Basch, MD, Memorial Sloan Kettering Cancer Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2006

Primær færdiggørelse (Faktiske)

1. marts 2013

Studieafslutning (Faktiske)

1. juni 2017

Datoer for studieregistrering

Først indsendt

27. december 2006

Først indsendt, der opfyldte QC-kriterier

27. december 2006

Først opslået (Skøn)

28. december 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2017

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CALGB-70501
  • UG1CA189823 (U.S. NIH-bevilling/kontrakt)
  • U10CA037447 (U.S. NIH-bevilling/kontrakt)
  • CDR0000521898 (Registry Identifier: NCI Physician Data Query)
  • NCI-2009-00489 (Registry Identifier: NCI Clinical Trial Reporting Program)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Spørgeskemaadministration

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in China

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner