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NCT Number: NCT01749995

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

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

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Key information

Conditions

Elderly Cancer Patients Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Neurocognitive Disorders

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital Groeninge, Cancer Center

Kortrijk, 8500, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

General Hospital Groeninge

Other

Registry information

Official study 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)

Acronym: PROACTIVE

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 17, 2012
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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