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

C

Centre Francois Baclesse

Status

Completed

Conditions

Cancer

Treatments

Other: Follow up by phone
Other: standardized cognitive rehabilitation
Other: Standardized home exercise
Other: Cognitive exams

Study type

Interventional

Funder types

Other

Identifiers

NCT01788618
COG REDUC

Details and patient eligibility

About

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

Full 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

Enrollment

168 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

168 participants in 3 patient groups

Experimental group
Other group
Description:
Cognitive exams at T0 and T3. 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
Treatment:
Other: Cognitive exams
Other: standardized cognitive rehabilitation
The control group 1 (Homework)
Other group
Description:
Cognitive exams at T0 and T3. 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
Treatment:
Other: Cognitive exams
Other: Standardized home exercise
Control group 2 ( telephone follow)
Other group
Description:
Cognitive exams at T0 and T3. 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
Treatment:
Other: Cognitive exams
Other: Follow up by phone

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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