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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Centre Francois Baclesse
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01788618
First received: February 8, 2013
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Cancer and Disorders of Cognitive Functions and Quality of Life: "Cognitive Rehabilitation in Patients Suffering From Cancer and Treated With Chemotherapy"

Resource links provided by NLM:


Further study details as provided by Centre Francois Baclesse:

Primary Outcome Measures:
  • Proportion of patients showing an improvement in the score of perceived deficiencies (score ranging from 0 to 72) of the FACT-Cog after care [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]

    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:
  • Evaluate the relationship between cognitive impairment and the parameters of the quality of life [ Time Frame: Baseline and month 3 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and month 3 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and month 3 ] [ Designated as safety issue: No ]

    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)



Estimated Enrollment: 168
Study Start Date: July 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental group
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
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)

Other: 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
The control group 1 (Homework)
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
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)

Other: 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
Control group 2 ( telephone follow)
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
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)

Other: 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01788618

Contacts
Contact: Florence JOLY-LOBBEDEZ, PHD 33 2 31 45 50 02 f.joly@baclesse.fr
Contact: Olivier RIGAL, MD 33 2 32 08 22 41 olivier.rigal@chb.unicancer.fr

Locations
France
Centre François Baclesse Recruiting
Caen, France, 14076
Contact: Florence JOLY-LOBBEDEZ, PHD    33 2 31 45 50 02    f.joly@baclesse.fr   
Sub-Investigator: Florence JOLY-LOBBEDEZ, PHD         
Sub-Investigator: Emmanuel SEVIN, MD         
Sub-Investigator: Djelila ALLOUACHE, MD         
Sub-Investigator: Christelle LEVY, MD         
Sub-Investigator: Sabine NOAL, MD         
Sub-Investigator: Christophe FRUCHART, MD         
Sub-Investigator: Stéphanie LHEUREUX, MD         
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Jérôme BARRIERE, MD    33 4 92 03 11 32    Jerome.barriere@nice.unicancer.fr   
Principal Investigator: Jérôme BARRIERE, MD         
Sub-Investigator: Jean-Marc FERRERO, MD         
Sub-Investigator: Philippe FOLLANA, MD         
Sub-Investigator: Eric François, MD         
Centre Henri Becquerel Recruiting
Rouen, France, 46038
Contact: Olivier RIGAL, MD    33 2 32 08 22 41    olivier.rigal@chb.unicancer.fr   
Principal Investigator: Olivier RIGAL, MD         
KURTZ Not yet recruiting
Strasbourg, France, 67091
Contact: Jean Emmanuel KURTZ, Pr       J-Emmanuel.KURTZ@chru-strasbourg.fr   
Principal Investigator: Jean Emmanuel KURTZ, Pr         
Institut Gustave Roussy Not yet recruiting
Villejuif, France, 94805
Contact: Sarah DAUCHY, MD    33 1 42 11 46 30    s.dauchy@igr.fr   
Sub-Investigator: Sarah DAUCHY, MD         
Sponsors and Collaborators
Centre Francois Baclesse
Investigators
Principal Investigator: Florence JOLY-LOBBEDEZ, PHD Centre François Baclesse
  More Information

No publications provided

Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT01788618     History of Changes
Other Study ID Numbers: COG REDUC
Study First Received: February 8, 2013
Last Updated: July 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Francois Baclesse:
Cognitive functions
Quality of life
Cancer

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 21, 2014