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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01788618
Enrollment
168
Registered
2013-02-11
Start date
2012-07-31
Completion date
2017-07-31
Last updated
2017-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cognitive functions, Quality of life, Cancer

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

Interventions

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)

OTHERstandardized 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

OTHERStandardized 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

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

Sponsors

Centre Francois Baclesse
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients showing an improvement in the score of perceived deficiencies (score ranging from 0 to 72) of the FACT-Cog after careup to 3 monthsEvaluate, 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

MeasureTime frameDescription
Evaluate the relationship between cognitive impairment and the parameters of the quality of lifeBaseline and month 3Cognitive 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 feltBaseline and month 3Cognitive 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 patientsBaseline and month 3Cognitive 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026