- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01846260
Predictive Value of the Distress Thermometer as a Predictive Screening Instrument to Detect Cancer-related Cognitive Impairment in Cancer Patients (CONCEPT)
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 administration of their therapy, some authors suggest an association with psychological risk factors such as distress. Distress, a multifactorial unpleasant emotional experience of a psychological (cognitive, behavioral and emotional), social and/or spiritual nature that may interfere with the ability to cope with cancer effectively, its physical symptoms and its treatment, can easily be assessed by the Distress Thermometer.
In this trial we aim to determine if the Distress Thermometer, accompanied by the 38-item Problem List, could predict cancer-related cognitive impairment in patients with hematologic malignancies, and in patients with gynecological, urological, breast, lung or gastro-intestinal cancer receiving curative radiotherapy, chemotherapy, radiochemotherapy, anti-hormonal or targeted therapy.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kortrijk, Belgium
- General Hospital Groeninge
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
- 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)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Validation of the Distress Thermometer, accompanied by the 38-item Problem List, as a screening tool to predict cancer-related cognitive impairment, measured through standard neuropsychological testing
Time Frame: 6 months
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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 impairment, measured through standard neuropsychological testing in cancer patients receiving curative (adjuvant) radiotherapy, chemotherapy, radiochemotherapy, radiobiotherapy, or targeted therapy.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Prevalence of cognitive impairments and distress in all cancer patients included in this study and per cohort in a general hospital in Belgium by use of the Distress Thermometer and neuropsychological assessment
Time Frame: 6 months
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6 months
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Comparison of subjective patient reported symptoms through self-reported measurements with objective neurocognitive test results and to examine the feasibility of these self-report assessment
Time Frame: 6 months
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6 months
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Evaluation of the performance of the distress thermometer to detect cancer-related cognitive impairments over time
Time Frame: 6 months
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6 months
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Determination of a cut-off score for the Distress Thermometer as a screening tool to detect cancer-related cognitive impairments over time by use of Receiver Operating Characteristics (ROC) curve
Time Frame: 6 months
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6 months
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Evaluation of distress scores compared to patients' quality of life post-treatment by use of EORTC QLQ C-30
Time Frame: 2 years
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2 years
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Other Outcome Measures
Outcome Measure |
Time Frame |
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Evaluation of lipid profiles at baseline to establish if fatty acid deficiency is associated with chemobrain through analysis of RBC fatty acid composition
Time Frame: 6 months
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6 months
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Evaluation of CRP-levels as a biomarker to predict cancer-related cognitive decline
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philip R Debruyne, MD, PhD, General Hospital Groeninge
Publications and helpful links
General Publications
- Lycke M, Pottel L, Pottel H, Ketelaars L, Stellamans K, Van Eygen K, Vergauwe P, Werbrouck P, Goethals L, Schofield P, Boterberg T, Debruyne PR. Predictors of baseline cancer-related cognitive impairment in cancer patients scheduled for a curative treatment. Psychooncology. 2017 May;26(5):632-639. doi: 10.1002/pon.4200. Epub 2016 Aug 1.
- Lycke M, Lefebvre T, Pottel L, Pottel H, Ketelaars L, Stellamans K, Eygen KV, Vergauwe P, Werbrouck P, Goethals L, Schofield P, Boterberg T, Debruyne PR. The distress thermometer predicts subjective, but not objective, cognitive complaints six months after treatment initiation in cancer patients. J Psychosoc Oncol. 2017 Nov-Dec;35(6):741-757. doi: 10.1080/07347332.2017.1365798. Epub 2017 Aug 17.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AZGS2013021
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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