CancerNCT01788618
Cancer and Disorders of Cognitive Functions and Quality of Life: "Cognitive Rehabilitation in Patients Suffering From Cancer and Treated With Chemotherapy"
A study testing Cognitive exams, standardized cognitive rehabilitation and Standardized home exercise in people with Cancer, run by Centre Francois Baclesse at 4 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Cognitive exams, standardized cognitive rehabilitation and Standardized home exercise
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 4 sitesFrance
- Study dates
- Jul 2012to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- Patient or opioids analgesics in Class 3
- Consumption of alcohol
- Patient unable to respond to cognitive tests and cognitive rehabilitation
- Refusal to participate
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre François Baclesse
Caen, 14076
Centre Henri Becquerel
Rouen, 46038
Centre Paul Strauss
Strasbourg
Institut Gustave Roussy
Villejuif, 94805
About this study
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
Read the 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
- Conditions
- Cancer
- Being tested
- Cognitive exams, standardized cognitive rehabilitation, Standardized home exercise, Follow up by phone
- Keywords
- Cognitive functions, Quality of life, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive examsOther
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 rehabilitationOther
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 exerciseOther
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 phoneOther
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Other | 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 Receives: Other: Cognitive exams; Other: standardized cognitive rehabilitation |
| The control group 1 (Homework) | Other | 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 Receives: Other: Cognitive exams; Other: Standardized home exercise |
| Control group 2 ( telephone follow) | Other | 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 Receives: Other: Cognitive exams; Other: Follow up by phone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients showing an improvement in the score of perceived deficiencies (score ranging from 0 to 72) of the FACT-Cog after care
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
Measured: up to 3 months
Secondary outcomes (3)
Evaluate the relationship between cognitive impairment and the parameters of the quality of life
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)
Measured: Baseline and month 3
Assess the relationships between goals disorders (measured by neuropsychological tests) and the patients felt
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)
Measured: Baseline and month 3
Study of different types of interest support the evolution of objective and subjective cognitive performance of patients
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)
Measured: Baseline and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startJul 2012
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence JOLY-LOBBEDEZ, PHD, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788618
- Sponsor's protocol ID
- COG REDUC
- Status last verified
- Aug 2015
- First submitted
- 8 Feb 2013
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer and Disorders of Cognitive Functions and Quality of Life: "Cognitive Rehabilitation in Patients Suffering From Cancer and Treated With Chemotherapy"
- ClinicalTrials.gov ID
- NCT01788618
- Acronym / sponsor ID
- COG REDUC
- Conditions
- Cancer
- Keywords
- Cognitive functions, Quality of life, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Other | Other: Cognitive exams, Other: standardized cognitive rehabilitationCognitive 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 |
| The control group 1 (Homework) | Other | Other: Cognitive exams, Other: Standardized home exerciseCognitive 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 |
| Control group 2 ( telephone follow) | Other | Other: Cognitive exams, Other: Follow up by phoneCognitive 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- Primary cancer of the central nervous system or brain metastases
- Pathology malignant hematologic
- Disorders of higher functions documented
- Pathology psychiatric scalable
- Use documented drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive examsPsychopathological 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 | Control group 2 ( telephone follow), Experimental group, The control group 1 (Homework) |
| standardized cognitive rehabilitationPatients 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 | Experimental group |
| Standardized home exerciseThese 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 | The control group 1 (Homework) |
| Follow up by phoneThese 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 | Control group 2 ( telephone follow) |
Primary outcome
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
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
3 secondary outcomes
Evaluate the relationship between cognitive impairment and the parameters of the quality of life
Time frame: Baseline and month 3
Assess the relationships between goals disorders (measured by neuropsychological tests) and the patients felt
Time frame: Baseline and month 3
Study of different types of interest support the evolution of objective and subjective cognitive performance of patients
Time frame: Baseline and month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence JOLY-LOBBEDEZ, PHD principal investigator
Centre François Baclesse
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive exams, standardized cognitive rehabilitation and Standardized home exercise in people with Cancer, run by Centre Francois Baclesse at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.