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Assessing Older Patients With Cancer

12. juli 2016 opdateret af: Alliance for Clinical Trials in Oncology

Development of a Geriatric Assessment Measure for Older Patients With Cancer

RATIONALE: Questionnaires that measure the ability of older patients to think, learn, remember, and make judgments and carry out daily activities may improve the ability to plan treatment for patients with cancer.

PURPOSE: This clinical trial is studying ways to assess older patients with cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Determine the feasibility of administration of the geriatric assessment in elderly patients with cancer.
  • Determine the percentage of patients able to complete the self-administered portion of the geriatric assessment without assistance.
  • Determine the length of time necessary to complete the geriatric assessment.
  • Determine the variance and number of missing items.
  • Assess patient satisfaction with the questionnaire by identifying items that are distressing or difficult to comprehend.
  • Assess the percentage of geriatric assessments that contain all three of the following items: Timed Up and Go Assessment, Blessed Orientation-Memory-Concentration Test, and healthcare professional-rated Karnofsky performance status.

Secondary

  • Determine the proportion of patients who are able to complete the self-report portion of the questionnaire without assistance and the length of time needed to complete the geriatric assessment within patients of various sociodemographic factors and educational status.

OUTLINE: This is a multicenter study. Patients are stratified according to age (65 to 69 years vs 70 years and over).

Patients undergo assessments of cognition using the Blessed Orientation-Memory-Concentration Test; functional status using the Timed Up and Go Assessment (measures physical mobility); and performance status using the healthcare professional-rated Karnofsky performance scale. These assessments are performed by healthcare personnel. Body mass index and the percentage of unintentional weight loss and the number of falls in the past 6 months are also assessed.

Patients also complete the following self-administered questionnaires: Instrumental Activities of Daily Living (measures level of functioning and need for services); Activities of Daily Living (measures higher levels of physical functioning); Karnofsky Self-Reported Performance Rating Scale (related to survival and clinically significant illness); Physical Health Section of the Older American Resources and Services Questionnaire (measures comorbidity and the impact on daily activities); Hospital Anxiety and Depression Scale; Medical Outcomes Study (MOS) Social Activity Limitations Measure (measures the impact of cancer on patients' social functioning); and MOS Social Support Survey Emotional/Information and Tangible Subscales (measures perceived availability of social support).

Patients then begin planned treatment.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

93

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Indiana
      • Elkhart, Indiana, Forenede Stater, 46515
        • Elkhart General Hospital
      • Kokomo, Indiana, Forenede Stater, 46904
        • Howard Community Hospital
      • La Porte, Indiana, Forenede Stater, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • South Bend, Indiana, Forenede Stater, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Forenede Stater, 46601
        • CCOP - Northern Indiana CR Consortium
      • South Bend, Indiana, Forenede Stater, 46617
        • Saint Joseph Regional Medical Center
      • South Bend, Indiana, Forenede Stater, 46601
        • Michiana Hematology-Oncology, PC - South Bend
    • Michigan
      • St. Joseph, Michigan, Forenede Stater, 49085
        • Lakeland Regional Cancer Care Center - St. Joseph
    • 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 York
      • East Syracuse, New York, Forenede Stater, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Comprehensive Cancer Center
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210-1240
        • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

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

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients aged 65 years and older with a histologically confirmed malignancy enrolled on any cooperative group-sponsored cancer treatment trial.

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignancy at any stage
  • Enrolled on any cooperative group-sponsored cancer treatment trial (treatment has not yet started), including trials on the Cancer Trials Support Unit

PATIENT CHARACTERISTICS:

  • Any performance status allowed
  • Must be able to follow directions in English
  • Sufficient cognitive and psychological function to give consent

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

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Patient assessment

Patients undergo assessments of cognition and performance status using the healthcare professional-rated Karnofsky performance scale. These assessments are performed by healthcare personnel. Body mass index and the percentage of unintentional weight loss and the number of falls in the past 6 months are also assessed.

Patients also complete self-administered questionnaires that measure level of functioning and need for services. It also includes questionnaires that measure higher levels of physical functioning, performance related to survival and clinically significant illness and measures of comorbidity and the impact on daily activities. Lastly, questionnaires are administered to measure the impact of cancer on patients' social functioning and perceived availability of social support.

Patients then begin planned treatment.
Adfærdsmæssigt: livskvalitetsspørgeskemaer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Mean and median time to complete the entire geriatric assessment
Tidsramme: Up to 3 years
Up to 3 years
Mean number of missing items in each subscale and the distribution of missing items
Tidsramme: Up to 3 years
Up to 3 years
Percentage of patients who identify a scale to be upsetting or difficult to understand
Tidsramme: Up to 3 years
Up to 3 years
Percentage of Geriatric Assessments for which all three items (Timed Up and Go Assessment, Blessed Orientation-Memory-Concentration Test, and the healthcare professional-rated Karnofsky performance status) are completed
Tidsramme: Up to 3 years
Up to 3 years

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: Alice B. Kornblith, PhD, Dana-Farber Cancer Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. december 2006

Primær færdiggørelse (Faktiske)

1. oktober 2011

Studieafslutning (Faktiske)

1. oktober 2011

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 (Skøn)

13. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • CALGB-360401
  • CDR0000523527 (Registry Identifier: NCI Physician Data Query)

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 .

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Betingelser

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