Clinical trial NCT01788618: Cancer and Disorders of Cognitive Functions and Quality of Life: "Cognitive Rehabilitation in Patients Suffering From Cancer and Treated With Chemotherapy"
Official title: Cancer and Disorders of Cognitive Functions and Quality of Life: "Cognitive Rehabilitation in Patients Suffering From Cancer and Treated With Chemotherapy"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cognitive functions
Quality of life
Cancer
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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
* 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

Primary outcomes:
measure: Proportion of patients showing an improvement in the score of perceived deficiencies (score ranging from 0 to 72) of the FACT-Cog after care
timeFrame: up to 3 months
Secondary outcomes:
measure: Evaluate the relationship between cognitive impairment and the parameters of the quality of life
timeFrame: Baseline and month 3
measure: Assess the relationships between goals disorders (measured by neuropsychological tests) and the patients felt
timeFrame: Baseline and month 3
measure: Study of different types of interest support the evolution of objective and subjective cognitive performance of patients
timeFrame: Baseline and month 3
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre François Baclesse
name: Florence JOLY-LOBBEDEZ, PHD
role: PRINCIPAL_INVESTIGATOR
References: