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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Philip Debruyne, General Hospital Groeninge
ClinicalTrials.gov Identifier:
NCT01749995
First received: December 11, 2012
Last updated: December 26, 2013
Last verified: December 2013
  Purpose

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
Elderly Cancer Patients
Cognitive Impairment

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by General Hospital Groeninge:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Validation of the Freund Clock Drawing Test by use of Receiver Operating Characteristic (ROC) analysis

  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
  • To determine the time-saving [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Determination of the time-saving when using the Freund Clock Drawing Test instead of the Folstein MMSE

  • To compare the Freund scoring system with other scoring systems (such as Watson and colleagues), when using a predrawn circle [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • To develop a tumour tissue database (bio bank) of elderly cancer patients, solely for scientific purposes [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01749995

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

Publications:
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. Journal of Geriatric Oncology. Published online on November 5 2012.

Responsible Party: Dr. Philip Debruyne, Consultant Medical Oncologist, General Hospital Groeninge
ClinicalTrials.gov Identifier: NCT01749995     History of Changes
Other Study ID Numbers: AZGS2012061
Study First Received: December 11, 2012
Last Updated: December 26, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by General Hospital Groeninge:
Elderly cancer patients
Screening tool
Cognitive impairment
Freund Clock Drawing Test

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 20, 2014