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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
164
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.
Institut Bergonié, Comprehensive Cancer Center
Bordeaux, France
Number of participants with improved quality of life (Emotional and functional QoL)
Improved QoL is defined as a significant improvement (i.e. at least a 3-point increase of the total score) in both the Emotional Well-Being (EWB) and Functional Well-Being (FWB) subscales of the FACT-B self-questionnaire (Functional Assessment of Cancer Therapy -Breast - Brady et al. J Clin Oncol 1997).
Time frame: 4 months after initiation of the cognitive stimulation protocol using the "onCOGITE" method
Number of participants with improved quality of life (physical QoL)
Improved QoL is defined as a significant improvement (i.e. at least a 3-point increase of the total score) in the physical Well-Being subscale of the FACT-B self-questionnaire (Functional Assessment of Cancer Therapy -Breast - Brady et al. J Clin Oncol 1997).
Time frame: 4 months after initiation of the cognitive stimulation protocol using the "onCOGITE" method
Number of participants with improved quality of life (Social/family QoL)
Improved QoL is defined as a significant improvement (i.e. at least a 3-point increase of the total score) in the Social/family subscale of the FACT-B self-questionnaire (Functional Assessment of Cancer Therapy -Breast - Brady et al. J Clin Oncol 1997).
Time frame: 4 months after initiation of the cognitive stimulation protocol using the "onCOGITE" method
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