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Validation of the Freund Clock Drawing Test to Screen for Cognitive Dysfunction in Cancer Patients (PROACTIVE)

11. februar 2021 opdateret af: Dr. Philip Debruyne, General Hospital Groeninge

Prospective Validation of the Use of the Freund Clock Drawing Test (CDT) to Screen for Cognitive Dysfunction in Cancer Patients Undergoing Comprehensive Geriatric Assessment (CGA)

A Comprehensive Geriatric Assessment (CGA) has become a fundamental aid in the evaluation and treatment planning of older cancer patients. Systematic reviews of trials of geriatric assessments have shown effectiveness when interventions are implemented. Although CGA is a fundamental tool in the care of the geriatric patient, the integration and application of this tool in oncologic practice are still in evolution. Cognition is one of the domains examined within a CGA. Studies have noted that up to 25% to 50% of older patients had cognitive abnormalities that warranted further evaluation. Cognitive dysfunctions can influence the ability to weigh the risks and benefits of cancer therapy, to comply with the suggested treatment plan, and to recognize the symptoms of toxicity that need medical attention. Recently, the Freund Clock Drawing Test (CDT) has been proposed as a quick and simple screening tool to assess cognitive dysfunction. A retrospective analysis on 105 cancer patients at the General Hospital Groeninge showed that a cut-off score of ≤ 4 for the CDT has a good AUC, sensitivity and specificity.

Aims

  1. To validate the Clock Drawing Test as a screening tool to identify elderly cancer patients in need of a more in-depth cognitive evaluation within a comprehensive geriatric assessment (CGA)
  2. Further registration of data in a database coupled to the Cancer Registry in the General Hospital Groeninge as set up by the PROGERCAN study

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Design: A prospective, observational, cohort study. All geriatric patients who are diagnosed with cancer will be screened by an oncology clinical nurse specialist or study collaborator with the G8 questionnaire. Patients who screen positive, will be refered to the multi-disciplinary onco-geriatric program where a member of the geriatric oncology team will implement a comprehensive geriatric evaluation under supervision of an oncologist and/or geriatrician, who will then formulate recommendations and might suggest referral to other health care providers.

Population: All consenting patients, aged ≥ 70, who are referred for anti-cancer treatment in the General Hospital Groeninge and who are in need of a CGA.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

200

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Kortrijk, Belgien, 8500
        • General Hospital Groeninge, 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

70 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

All consenting patients, aged ≥ 70, who are referred for anti-cancer treatment in the General Hospital Groeninge and who are in need of a CGA.

Beskrivelse

Inclusion Criteria:

  • Patients should have reached the age of 70 or more at the moment of enrolment
  • Patients should be eligible for standard CGA as per local practice (e.g. on the basis of positive screening with G8 or referred by a treating physician on the basis of clinical suspicion of vulnerability or frailty)
  • Histologically confirmed diagnosis of cancer. All stages of cancer are eligible.
  • Patients should be fluent in Dutch or French
  • Patients must receive their primary oncology care (surgery, course of (neo)adjuvant or palliative chemotherapy, radiotherapy, targeted therapy, palliative care, experimental treatment as part of a clinical trial,...) planned in the General Hospital Groeninge
  • Patients can be included before or at the start of a line of treatment but not during a line of treatment
  • Patients should have signed informed consent

Exclusion Criteria:

  • Patients who do not match the inclusion criteria
  • Patients who are visiting the oncology clinic for a second opinion and do not wish to be treated in the General Hospital Groeninge
  • Patients who already started a respective line of treatment
  • Patients deemed fit on the basis of negative screening (negative result on G8) unless the treating physician suspects vulnerability or frailty based on clinical judgement

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Validation of the Freund Clock Drawing Test, and Its Predefined Cut-off of ≤ 4, as a Screening Tool to Identify Elderly Cancer Patients in Need of a More In-depth Cognitive Evaluation With the Folstein MMSE Within Comprehensive Geriatric Assessment
Tidsramme: Baseline
A Receiver Operating Characteristic (ROC) analysis was applied in order to validate the Freund Clock Drawing Test at its predefined cut-off of ≤ 4. This ROC analysis illustrates the capacity of the Freund Clock Drawing Test to identify elderly cancer patients in need of a more in-depth cognitive evaluation with the Folstein MMSE within comprehensive geriatric assessment. The ROC curve is a fundamental tool for diagnostic test evaluation. In a ROC curve the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity) for different cut-off points of a parameter. The AUC (Area Under Curve) is the area enclosed by the ROC curve. The range of possible AUC values is [0, 1]. A perfect classifier has AUC = 1 and a completely random classifier has AUC = 0.5. Usually, themodel will score somewhere in between.
Baseline
Further Registration of Data in a Database Coupled to the Cancer Registry in the General Hospital Groeninge as Set up by the PROGERCAN Study
Tidsramme: Baseline
During the PROGERCAN study, a database was set up in which the results of the CGA were coupled to the data available in the Cancer Registry of the General Hospital Groeninge. In this project, we aim continue this registration.
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of the Mini-Cog (Cognitive Screening Tool Consisting of a Clock Drawing With 3-word Recall Test) When Using the Freund CDT
Tidsramme: Baseline
Baseline
To Determine the Time-saving
Tidsramme: Baseline
Determination of the time-saving when using the Freund Clock Drawing Test instead of the Folstein MMSE
Baseline
To Compare the Freund Scoring System With Other Scoring Systems (Such as Watson and Colleagues), When Using a Predrawn Circle
Tidsramme: Baseline
Baseline
To Develop a Tumour Tissue Database (Bio Bank) of Elderly Cancer Patients, Solely for Scientific Purposes
Tidsramme: Baseline
Baseline

Samarbejdspartnere og efterforskere

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

Sponsor

General Hospital Groeninge

Efterforskere

  • Ledende efterforsker: Philip R Debruyne, MD, PhD, MSc, FRCP, AZ Groeninge

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. november 2012

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

11. december 2012

Først indsendt, der opfyldte QC-kriterier

12. december 2012

Først opslået (Skøn)

17. december 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AZGS2012061

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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Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner