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

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

26. juni 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

325

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

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

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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: (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.
Annen: Spørreskjemaadministrasjon
Hjelpestudier
Annen: internet-based intervention
Use the STAR database system
Annen: assessment of therapy complications
Use the STAR database system

Hva måler studien?

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

Samarbeidspartnere og etterforskere

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

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

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

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)

1. desember 2006

Primær fullføring (Faktiske)

1. mars 2013

Studiet fullført (Faktiske)

1. juni 2017

Datoer for studieregistrering

Først innsendt

27. desember 2006

Først innsendt som oppfylte QC-kriteriene

27. desember 2006

Først lagt ut (Anslag)

28. desember 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. juni 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. juni 2017

Sist bekreftet

1. juni 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

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