Clinical trial NCT01749995: Validation of the Freund Clock Drawing Test to Screen for Cognitive Dysfunction in Cancer Patients
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elderly Cancer Patients
Cognitive Impairment
Keywords: Elderly cancer patients
Screening tool
Cognitive impairment
Freund Clock Drawing Test
Lead sponsor: General Hospital Groeninge
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 200
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Baseline
measure: Further Registration of Data in a Database Coupled to the Cancer Registry in the General Hospital Groeninge as Set up by the PROGERCAN Study
timeFrame: Baseline
Secondary outcomes:
measure: Evaluation of the Mini-Cog (Cognitive Screening Tool Consisting of a Clock Drawing With 3-word Recall Test) When Using the Freund CDT
timeFrame: Baseline
measure: To Determine the Time-saving
timeFrame: Baseline
measure: To Compare the Freund Scoring System With Other Scoring Systems (Such as Watson and Colleagues), When Using a Predrawn Circle
timeFrame: Baseline
measure: To Develop a Tumour Tissue Database (Bio Bank) of Elderly Cancer Patients, Solely for Scientific Purposes
timeFrame: Baseline
Other outcomes:
Locations:
city: Kortrijk
country: Belgium
facility: General Hospital Groeninge, Cancer Center
Study officials:
affiliation: AZ Groeninge
name: Philip R Debruyne, MD, PhD, MSc, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ketelaars L, Pottel L, Lycke M, Goethals L, Ghekiere V, Santy L, Boterberg T, Van Den Noortgate N, Pottel H, Debruyne PR. Use of the Freund clock drawing test within the Mini-Cog as a screening tool for cognitive impairment in elderly patients with or without cancer. J Geriatr Oncol. 2013 Apr;4(2):174-82. doi: 10.1016/j.jgo.2012.10.175. Epub 2012 Nov 2.
citation: Lycke M, Ketelaars L, Boterberg T, Pottel L, Pottel H, Vergauwe P, Goethals L, Van Eygen K, Werbrouck P, Debruyne D, Derijcke S, Borms M, Ghekiere V, Wildiers H, Debruyne PR. Validation of the Freund Clock Drawing Test as a screening tool to detect cognitive dysfunction in elderly cancer patients undergoing comprehensive geriatric assessment. Psychooncology. 2014 Oct;23(10):1172-7. doi: 10.1002/pon.3540. Epub 2014 Apr 11.