Viewing Study NCT01846260



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Last Modification Date: 2024-10-26 @ 11:06 AM
Study NCT ID: NCT01846260
Status: COMPLETED
Last Update Posted: 2018-02-15
First Post: 2013-05-01

Brief Title: Predictive Value of the Distress Thermometer as a Predictive Screening Instrument to Detect Cancer-related Cognitive Impairment in Cancer Patients
Sponsor: General Hospital Groeninge
Organization: General Hospital Groeninge

Study Overview

Official Title: Predictive Value of the Distress Thermometer as a Predictive Screening Instrument to Detect Cancer-related Cognitive Impairment in Cancer Patients
Status: COMPLETED
Status Verified Date: 2018-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CONCEPT
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 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 andor 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
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 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None