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

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ClinicalTrials.gov Identifier: NCT01749995
Recruitment Status : Completed
First Posted : December 17, 2012
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Philip Debruyne, General Hospital Groeninge

Brief Summary:

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

Condition or disease
Elderly Cancer Patients Cognitive Impairment

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)
Study Start Date : November 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup




Primary Outcome Measures :
  1. 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 [ Time Frame: 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.

  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 [ Time Frame: 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.


Secondary Outcome Measures :
  1. Evaluation of the Mini-Cog (Cognitive Screening Tool Consisting of a Clock Drawing With 3-word Recall Test) When Using the Freund CDT [ Time Frame: Baseline ]
  2. To Determine the Time-saving [ Time Frame: Baseline ]
    Determination of the time-saving when using the Freund Clock Drawing Test instead of the Folstein MMSE

  3. To Compare the Freund Scoring System With Other Scoring Systems (Such as Watson and Colleagues), When Using a Predrawn Circle [ Time Frame: Baseline ]
  4. To Develop a Tumour Tissue Database (Bio Bank) of Elderly Cancer Patients, Solely for Scientific Purposes [ Time Frame: Baseline ]


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749995


Locations
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Belgium
General Hospital Groeninge, Cancer Center
Kortrijk, Belgium, 8500
Sponsors and Collaborators
General Hospital Groeninge

Publications of Results:
Other Publications:
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Responsible Party: Dr. Philip Debruyne, Consultant Medical Oncologist, General Hospital Groeninge
ClinicalTrials.gov Identifier: NCT01749995    
Other Study ID Numbers: AZGS2012061
First Posted: December 17, 2012    Key Record Dates
Results First Posted: September 11, 2019
Last Update Posted: September 11, 2019
Last Verified: August 2019
Keywords provided by Dr. Philip Debruyne, General Hospital Groeninge:
Elderly cancer patients
Screening tool
Cognitive impairment
Freund Clock Drawing Test
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders