Cancer and Disorders of Cognitive Functions and Quality of Life: "Cognitive Rehabilitation in Patients Suffering From Cancer and Treated With Chemotherapy"
NCT ID: NCT01788618
Last Updated: 2017-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
168 participants
INTERVENTIONAL
2012-07-31
2017-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact on Cognitive Function and Quality of Life of Adjuvant Chemotherapy in Patients Aged Over 65 Years: Application to Breast Cancer or Colon
NCT01333735
Management of Cognitive Difficulties After Cancer Treatments in Women Treated for Breast Cancer: Feasibility Study (Step 1 of the Cog-Stim Protocol)
NCT04213365
Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer
NCT06027632
Relations Between Cognitive Complaints and Cognitive Scores Goals in Cancer: Assessment of Metamemory
NCT02212132
Oral Therapies in Oncology: Cognitive Function and Compliance
NCT01597284
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
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
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 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
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)
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Francois Baclesse
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Florence JOLY-LOBBEDEZ, PHD
Role: PRINCIPAL_INVESTIGATOR
Centre François Baclesse
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre François Baclesse
Caen, , France
Centre Henri Becquerel
Rouen, , France
Centre Paul Strauss
Strasbourg, , France
Institut Gustave Roussy
Villejuif, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COG REDUC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.