Remediation for Mild Cognitive Deficits After Cancer (EURECA)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Breast Cancer; Cognitive Remediation

Treatments: Behavioral: Cognitive remediation program

Study type: Interventional

Funder types: Other

Identifiers

NCT04808674

2021-A00798-33 (Other Identifier)

69HCL20_1018

Details and patient eligibility

About

Cancer survival rates have improved significantly over the past decades and patients now experience a number of side effects including cancer-related cognitive impairment (CRCI): problems with memory, executive function, attention, and difficulties performing two tasks at the same time. The frequency of CRCI in cancer patients is estimated to be between 10 to 40%, and more than 50% of patients describe difficulties in their daily life. These cognitive difficulties negatively impact the patient's quality of life as well as that of their family, and can also have negative consequences for their social and professional reintegration once cancer treatment is finished. Despite an increasing number of studies on CRCI, a standard of care for patients with CRCI after breast cancer is yet to be established. In the absence of clear directives, and in an attempt to respond to the increasing demand to provide care for breast cancer patients with CRCI, physical medicine and rehabilitation units in France have started providing day-hospital multidisciplinary interventions. The objective of this project is to use the single case experimental design method to investigate the efficacy of two such rehabilitation programs: a group-based program and a one-on-one program.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treated in the past for breast cancer with chemotherapy, surgery, and / or radiotherapy,
• Admitted as a day patient at the Henry Gabrielle Hospital or the Pontchaillou CHU Hospital during the study,
• Given free, informed consent in writing after being informed orally and in writing of the how the study will proceed.

Exclusion criteria

• Presence of another active cancer,
• Ongoing chemotherapy and/or radiotherapy treatment,
• Active progression of breast cancer,
• History of neurological or psychiatric conditions,
• Major disturbances in comprehension that prevent them giving free, informed consent,
• Pregnant, parturient or breastfeeding women,
• Person under a legal protection measure such as guardianship or curatorship,
• People not affiliated to a social security scheme (French Social Security) or beneficiaries of a similar scheme.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Group-based cognitive remediation program

Experimental group

Description:

Patients are admitted to the day hospital 2 days a week for 6 weeks and participate in a group-based (4 patients per group) rehabilitation program conducted by a multidisciplinary team including a PMR doctor, a neuropsychologist, an occupational therapist, and a physical activity monitor).

Treatment:

Behavioral: Cognitive remediation program

One-on-one cognitive remediation program

Experimental group

Description:

Patients are admitted to the day hospital 5 days a week for 6 weeks and participate in a one-on-one intensive rehabilitation program conducted by a multidisciplinary team including a speech therapist, neuropsychologist, occupational therapist, physiotherapist, physical activity monitor and a psychologist.

Treatment:

Behavioral: Cognitive remediation program