Clinical trial NCT05690828: Evaluation of Cognitive Management for Chemobrain in Patients Treated for Breast Cancer.
Official title: Etude e-ONCOGITE : Évaluation d'Une Prise en Charge Cognitive adaptée au " Chemobrain" Chez Des Patientes traitées Pour un Cancer de Sein.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Cognition
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: University of Bordeaux
name: Association Oncogite
First posted: 2023-01-19
Enrollment: 164
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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).

Primary outcomes:
measure: Number of participants with improved quality of life (Emotional and functional QoL)
timeFrame: 4 months after initiation of the cognitive stimulation protocol using the "onCOGITE" method
Secondary outcomes:
measure: Number of participants with improved quality of life (physical QoL)
timeFrame: 4 months after initiation of the cognitive stimulation protocol using the "onCOGITE" method
measure: Number of participants with improved quality of life (Social/family QoL)
timeFrame: 4 months after initiation of the cognitive stimulation protocol using the "onCOGITE" method
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié, Comprehensive Cancer Center
Study officials:
affiliation: v.gerat-muller@bordeaux.unicancer.fr
name: Véronique GERAT-MULLER, PhD
role: PRINCIPAL_INVESTIGATOR
References: