NCT01788618

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 28, 2017

Status Verified

August 1, 2015

Enrollment Period

5 years

First QC Date

February 8, 2013

Last Update Submit

July 27, 2017

Conditions

Cancer

Keywords

Cognitive functionsQuality of lifeCancer

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 3 months

Secondary Outcomes (3)

  • Evaluate the relationship between cognitive impairment and the parameters of the quality of life

    Baseline and month 3

  • Assess the relationships between goals disorders (measured by neuropsychological tests) and the patients felt

    Baseline and month 3

  • Study of different types of interest support the evolution of objective and subjective cognitive performance of patients

    Baseline and month 3

Study Arms (3)

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

Other: Cognitive examsOther: 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

Other: Cognitive examsOther: 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

Other: Cognitive examsOther: Follow up by phone

Interventions

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)

Control group 2 ( telephone follow)Experimental groupThe control group 1 (Homework)
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

Experimental group
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

The control group 1 (Homework)
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

Control group 2 ( telephone follow)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre François Baclesse

Caen, 14076, France

Location

Centre Henri Becquerel

Rouen, 46038, France

Location

Centre Paul Strauss

Strasbourg, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Florence JOLY-LOBBEDEZ, PHD

    Centre François Baclesse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2013

First Posted

February 11, 2013

Study Start

July 1, 2012

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 28, 2017

Record last verified: 2015-08

Locations

FR(4)