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Clinical Trials/NCT01788618
NCT01788618
Completed
Not Applicable

Cancer and Disorders of Cognitive Functions and Quality of Life: "Cognitive Rehabilitation in Patients Suffering From Cancer and Treated With Chemotherapy"

Centre Francois Baclesse4 sites in 1 country168 target enrollmentJuly 2012
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Centre Francois Baclesse
Enrollment
168
Locations
4
Primary Endpoint
Proportion of patients showing an improvement in the score of perceived deficiencies (score ranging from 0 to 72) of the FACT-Cog after care
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Our study aims to measure the impact of cognitive rehabilitation workshops on the development of cognitive functions and quality of life of patients expressing a cognitive complaint

Detailed Description

The main objective of our study was to evaluate, in patients treated for cancer expressing the cognitive complaint during or after treatment, interest workshops on improving cognitive rehabilitation felt their cognitive functions and their quality of life. The primary endpoint was the proportion of patients showing an improvement in the score of perceived deficiencies (score ranging from 0 to 72) of the FACT-Cog after treatment. The FACT-Cog is a self-administered questionnaire assessing the patients felt their cognitive difficulties (memory, attention, concentration) and the impact of these difficulties on their quality of life. The improvement is defined as an increase of 7 points \>= cognitive score won by the (a) patient (e) after the treatment

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
July 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Francois Baclesse
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients older than 18 years
  • Solid tumor or haematological
  • Chemotherapy and / or targeted therapy in the adjuvant or metastatic
  • Sequential processing
  • Subjective cognitive complaints during or after treatment assessed by four items of the FACT-COG (impact on quality of life). Score ≥ 4/16 questions Q35, Q37, Q38 and Q41 FACT COG - Patient in remission or pause therapeutic
  • Subjective between 1 month and 5 years after the end of chemotherapy and / or targeted therapy cognitive complaints (ongoing treatment with Herceptin is not a non-inclusion criteria)
  • Lack of personality disorders and / or psychiatric disorder scalable
  • No known brain metastases
  • Lack of primary brain tumor
  • Lack of analgesic treatment with opioids or Class 3

Exclusion Criteria

  • Primary cancer of the central nervous system or brain metastases
  • Pathology malignant hematologic
  • Disorders of higher functions documented
  • Pathology psychiatric scalable
  • Use documented drug
  • Cancer treated in childhood
  • Patient or opioids analgesics in Class 3
  • Consumption of alcohol
  • Patient unable to respond to cognitive tests and cognitive rehabilitation
  • Refusal to participate

Outcomes

Primary Outcomes

Proportion of patients showing an improvement in the score of perceived deficiencies (score ranging from 0 to 72) of the FACT-Cog after care

Time Frame: up to 3 months

Evaluate, in patients treated for cancer expressing a cognitive complaint during or after the treatment, the interest workshops on improving cognitive rehabilitation felt their cognitive function and quality of life. Autoquestionnary FACT COG

Secondary Outcomes

  • Evaluate the relationship between cognitive impairment and the parameters of the quality of life(Baseline and month 3)
  • Assess the relationships between goals disorders (measured by neuropsychological tests) and the patients felt(Baseline and month 3)
  • Study of different types of interest support the evolution of objective and subjective cognitive performance of patients(Baseline and month 3)

Study Sites (4)

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