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

Not Applicable

Completed

• Conditions: Cancer

• Registration Number: NCT01788618
• Lead Sponsor: Centre Francois Baclesse

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

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-02-08
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-11
• Status Verified: 2015-08
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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
• Having signed informed consent to participate in the study
• Mastery of the French language

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Name	Time	Method
Evaluate the relationship between cognitive impairment and the parameters of the quality of life	Baseline and month 3	Cognitive assessment: MMS, Test de Grober et Buschke, mémoire des chiffres (WAIS IV), séquence lettres-chiffres (WAIS IV), arithmétique (WAIS IV), Trail Making Test, Fluence verbale, D2, Code (WAIS IV)
Assess the relationships between goals disorders (measured by neuropsychological tests) and the patients felt	Baseline and month 3	Cognitive assessment: MMS, Test de Grober et Buschke, mémoire des chiffres (WAIS IV), séquence lettres-chiffres (WAIS IV), arithmétique (WAIS IV), Trail Making Test, Fluence verbale, D2, Code (WAIS IV)
Study of different types of interest support the evolution of objective and subjective cognitive performance of patients	Baseline and month 3	Cognitive assesment: MMS, Test de Grober et Buschke, mémoire des chiffres (WAIS IV), séquence lettres-chiffres (WAIS IV), arithmétique (WAIS IV), Trail Making Test, Fluence verbale, D2, Code (WAIS IV)

Trial Locations

Locations (4)

Centre François Baclesse; 🇫🇷 Caen, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France