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Trial Title:
Evaluation of Cognitive Management for Chemobrain in Patients Treated for Breast Cancer.
NCT ID:
NCT05690828
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Chemotherapy-Related Cognitive Impairment
Conditions: Keywords:
Cognition
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Cognitive remediation
Description:
The cognitive remediation programme shall be run either in video workshops or face to
face workshops and in home sessions via a web app. The programme will run for 4 months
during which there will be 3 different evaluations. A first evaluation after
randomisation, a second evaluation 4 months after inclusion (corresponding to the end of
the programme), and a third evaluation 8 months after inclusion for the experimental
group (4 months after the end of the programme). The face to face workshops will take 8
to 10 participants and will be led by a neuropsychologist.
Arm group label:
Group 1 (Cognitive remediation)
Summary:
This project will investigate the efficacy of a cognitive remediation programme in
patients treated for breast cancer. patients will be randomized between "no intervention"
and "intervention programme". Efficay will be assessed in term of improved quality of
life.
Detailed description:
Medical progress in the treatment of cancer has prolonged patients' life expectancy. This
improvement has led researchers to become concerned about the long-term negative effects
of cancer treatments on quality-of-life. In particular, previous studies have identified
complaints that have been submitted concerning the cognitive status of patients treated
with chemotherapy (Berglund et coll., 1991). All of these cognitive changes are
collectively grouped under the term chemobrain.
The consequences of treatments remain however underestimated, as the priority when
diagnosing cancer remains the patient's short- to medium-term survival; yet,
quality-of-life contributes to the long-term survival of patients (Kramer, 2000).
In addition to medical treatments, psychosocial care adapted to the specific needs of
subjects is thus important for improving their quality-of-life and helping them return to
work. Even if initiatives have multiplied over the past few decades in the psychosocial
management of these subjects (e.g., supportive care), that related to cognitive disorders
in subjects having survived cancer remains a little documented field. Cognitive
deficiency in cancer survivors is said to be moderate (Razaq et coll., 2017), which makes
survivors ideal candidates for cognitive rehabilitation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Women aged 20 to 60 years inclusive.
2. Localised breast cancer having required neoadjuvant or adjuvant chemotherapy, the
last cycle of which took place between 2 and 24 months prior to inclusion.
3. Informed consent dated and signed.
4. Patient with French social security cover in accordance with French law on
biomedical research (Article 1121-11 of the French code of public health).
Exclusion Criteria:
1. Metastatic breast cancer.
2. Presence of unstable psychiatric or neurological disorders likely to affect
cognition (information requested directly from the participant)
3. History of drug abuse.
4. Patient who cannot read or understand French.
5. Patient already included in this study.
6. Patient having participated in onCOGITE workshops.
7. Patient participating in another clinical trial evaluating cognitive remediation.
8. Patient deprived of freedom or subject to legal protection measures (under
guardianship, in custody of the court, or family-member guardianship order).
Gender:
Female
Minimum age:
20 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Bergonié, Comprehensive Cancer Center
Address:
City:
Bordeaux
Country:
France
Status:
Recruiting
Start date:
February 1, 2023
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Institut Bergonié
Agency class:
Other
Collaborator:
Agency:
University of Bordeaux
Agency class:
Other
Collaborator:
Agency:
Association Oncogite
Agency class:
Other
Source:
Institut Bergonié
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05690828
