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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01788618
• Other study ID #: COG REDUC
• Status: Completed
• Phase: N/A
• First received: February 8, 2013
• Last updated: July 27, 2017
• Start date: July 2012
• Est. completion date: July 2017

Study information

• Verified date: August 2015
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Cognitive exams
Psychopathological assessment (T0 and T3): Scale of Spielberger The self-administered questionnaire CES-D Cognitive assessment(T0 and T3): - MMS, Grober and Buschke test, memory for numbers (WAIS IV) sequence of numbers and letters (WAIS IV), arithmetic (WAIS IV), Trail Making Test, verbal Fluence, D2, Code (WAIS IV) Quality of Life: FACT-G and FACT-An Fatigue Module (T0 and T3): Self-assessment FACT-COG (T0,every months until T3)
• standardized cognitive rehabilitation
Patients will achieve 9 standardized cognitive rehabilitation sessions with the RehaCom ® software (over 3 months), and a self-assessment of their monthly experienced cognitive functioning using the self-administered questionnaire FACT-Cog
• Standardized home exercise
These patients will take part in 9 sessions standardized home exercise (over 3 months), and a self-assessment every month felt their cognitive functioning using the self-administered questionnaire FACT Cog
• Follow up by phone
These patients receive follow-up by phone (9 telephone calls over a period of 3 months) standardized optics to know the evolution of the disorder and felt the same way as for the other groups, a monthly self-assessment the feeling of cognitive functioning using the self-administered questionnaire FACT-Cog

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen
France	Centre Henri Becquerel	Rouen
France	Centre Paul Strauss	Strasbourg
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients showing an improvement in the score of perceived deficiencies (score ranging from 0 to 72) of the FACT-Cog after care	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	up to 3 months
Secondary	Evaluate the relationship between cognitive impairment and the parameters of the quality of life	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)	Baseline and month 3
Secondary	Assess the relationships between goals disorders (measured by neuropsychological tests) and the patients felt	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)	Baseline and month 3
Secondary	Study of different types of interest support the evolution of objective and subjective cognitive performance of patients	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)	Baseline and month 3