Clinical trial NCT04808674: Remediation for Mild Cognitive Deficits After Cancer
Official title: EvalUation of REmediation Programs for Patients Suffering From Mild Cognitive Deficits After CAncer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Remediation
Breast Cancer
Keywords: Neuropsychology
psychological distress
quality of life
rehabilitation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Self-reported cognitive function
timeFrame: 16 weeks
Secondary outcomes:
measure: Neuropsychological function
timeFrame: 16 weeks
measure: Psychological distress
timeFrame: 16 weeks
measure: Quality of Life with FACT-B questionnaire
timeFrame: 16 weeks
measure: Fatigue
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Groupement hospitalier sud - Hôpital Henry Gabrielle - Service de médecine physique et de réadaptation
city: Rennes
country: France
facility: Hôpital Pontchaillou - Service de Médecine Physique et de Réadaptation
Study officials:
affiliation: Service de médecine physique et de réadaptation, HCL,
name: Sophie JACQUIN-COURTOIS, PhD
role: PRINCIPAL_INVESTIGATOR
References: