Remediation for Mild Cognitive Deficits After Cancer

Breast Cancer Clinical Trial

— EURECA  

Official title:

EvalUation of REmediation Programs for Patients Suffering From Mild Cognitive Deficits After CAncer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04808674
• Other study ID #: 69HCL20_1018
• Secondary ID: 2021-A00798-33
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2021
• Est. completion date: July 17, 2025

Study information

• Verified date: January 2023
• Source: Hospices Civils de Lyon
• Contact: Sophie JACQUIN-COURTOIS, PhD
• Phone: 04.78.86.50.64
• Email: sophie.courtois[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 17, 2025
• Est. primary completion date: July 17, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Cognition Disorders
• Cognitive Dysfunction
• Cognitive Remediation

Intervention

Behavioral:
• Cognitive remediation program
Evaluation of REmediation programs for patients suffering from mild cognitive deficits after Cancer

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Groupement hospitalier sud - Hôpital Henry Gabrielle - Service de médecine physique et de réadaptation	Lyon
France	Hôpital Pontchaillou - Service de Médecine Physique et de Réadaptation	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported cognitive function	The Fact-COG questionnaire assesses subjective cognitive impairment. The score directly reflects the patient's feelings about/perceptions of their cognitive function over the previous week. A total score out of 132 is obtained as well as 4 subscales: Perceived Cognitive Impairments (0-72), Impact on Quality of Life (0-16), Comments from Others (0-16), and Perceived Cognitive Abilities (0-28).	16 weeks
Secondary	Neuropsychological function	Neuropsychological function will be measured using three sub-tests of the Test of Attentional Performance (alertness, covert shift of attention, divided attention), the Paced Auditory Serial Addition Test, the Montreal Cognitive neuropsychological Assessment, and the Symbol Digit Modalities Test.	16 weeks
Secondary	Psychological distress	Psychological distress will be measured using 4 questionnaires: The Hospital Anxiety and Depression Scale; the Brief Symptom Inventory-18; the Rosenberg self-esteem scale; the MCQ-30 Meta-cognition self-report questionnaire.	16 weeks
Secondary	Quality of Life with FACT-B questionnaire	The FACT-B questionnaire assesses cancer-related quality of life. A total score out of 148 is obtained as well as 5 subscales: Physical Well-Being (0-28), Social/Family Well-Being (0-28), Functional-Well-Being (0-28), Emotional Well-Being (0-24), and Breast Cancer Subscale (0-40).	16 weeks
Secondary	Fatigue	The FACTIT-Fatigue questionnaire assesses fatigue/ tiredness and its impact on daily activities and functioning in chronic disease. A total score out of 52 is obtained.	16 weeks