Status:
COMPLETED
Predictive Value of the Distress Thermometer as a Predictive Screening Instrument to Detect Cancer-related Cognitive Impairment in Cancer Patients
Lead Sponsor:
General Hospital Groeninge
Conditions:
Cancer Patients Eligible for a Treatment With Curative Intent
Cognitive Impairment
Eligibility:
All Genders
18+ years
Brief Summary
Cognitive impairment associated with chemotherapy is an important reported post-treatment side-effect among breast and other cancer survivors. As some patients report cognitive complaints before the a...
Detailed Description
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. Con...
Eligibility Criteria
Inclusion
- 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
- Patients younger than 18 at the time of enrollment
- Patients who present with a cognitive impairment
- Patient receiving a treatment with palliative intent
- Patients who had surgery in the three weeks preceding the baseline assessment
- Patients diagnosed with primary or secondary brain tumors
- Patients with a prior history of cancer during the last 5 years, 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)
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01846260
Start Date
April 1 2013
End Date
March 1 2016
Last Update
February 15 2018
Active Locations (1)
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1
General Hospital Groeninge
Kortrijk, Belgium