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Predictive Value of the Distress Thermometer as a Predictive Screening Instrument to Detect Cancer-related Cognitive Impairment in Cancer Patients


N/A
18 Years
N/A
Open (Enrolling)
Both
Cancer Patients Eligible for a Treatment With Curative Intent, Cognitive Impairment

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Trial Information

Predictive Value of the Distress Thermometer as a Predictive Screening Instrument to Detect Cancer-related Cognitive Impairment in Cancer Patients


Design: Prospective, observational study. All cancer patients of the above mentioned cancer
types receiving an anticancer treatment with curative intent will be asked to participate to
this study. Consenting patients will undergo serial assessment at baseline, and 6 months
after inclusion. Patient will be screened by the Distress Thermometer and 38-item Problem
List followed by a neuropsychological assessment and self-assessment tools.


Inclusion Criteria:



- Patients should have reached a minimum age of 18 years at the time of enrolment

- Newly detected histologically confirmed diagnosis of a solid (lung,
gastro-intestinal, GIST, urological, prostate, breast, sarcoma or gynecological
cancer) or hematologic malignancy

- Patients should receive a treatment with curative intent based on the investigator's
judgment or have an expected median overall survival of at least 5 years

- Patients scheduled to receive (adjuvant) radiotherapy, chemotherapy, radiobiotherapy,
radiochemotherapy, anti-hormonal or targeted therapy with curative intent

- Patients should be able to adequately communicate in Dutch

- Patients should present with a sufficient mental and physical functional status
(according to investigator's judgment and first baseline assessment) for completing
the questionnaires and neuropsychological assessment

Exclusion Criteria:

- Patients younger than 18 at the time of enrollment

- Patients who present with a cognitive impairment (based on the baseline assessment)

- Patient receiving a treatment with palliative intent

- Patients who had surgery in the month preceding the baseline assessment

- Patients who are scheduled to receive surgery in the first five months after the
baseline assessment

- Patients diagnosed with primary or secondary brain tumors

- Patients with a prior history of cancer, with or without chemotherapy or radiotherapy

- Patients suffering from organic brain disease

- Patients with an untreated or unstable major medical condition

- Patients who are alcohol or drug dependent

- Patients showing signs of mental deterioration

- Patients with dementia (DSM-IV criteria)

- Patients with a major psychiatric or neurologic disorder that could potentially
invalidate assessment; a prior or current diagnosis of a depressive or anxiety
disorder is allowed

- Patients presenting with a condition other than cancer in which fatigue is a
prominent symptom (such as chronic fatigue symptom)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Validation of the Distress Thermometer, accompanied by the 38-item Problem List, as a screening tool to predict cancer-related cognitive decline, measured through standard neuropsychological testing

Outcome Description:

The primary objective of this observational study is to validate the Distress Thermometer, accompanied by the 38-item Problem List, as a screening tool to predict cancer-related cognitive decline, measured through standard neuropsychological testing in cancer patients receiving curative (adjuvant) radiotherapy, chemotherapy, radiochemotherapy, radiobiotherapy, or targeted therapy.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Philip R Debruyne, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

General Hospital Groeninge

Authority:

Belgium: Ethics Committee

Study ID:

AZGS2013021

NCT ID:

NCT01846260

Start Date:

April 2013

Completion Date:

Related Keywords:

  • Cancer Patients Eligible for a Treatment With Curative Intent
  • Cognitive Impairment
  • Cognition Disorders

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