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Remediation for Mild Cognitive Deficits After Cancer (EURECA)

Primary Purpose

Cognitive Remediation, Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive remediation program
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Remediation focused on measuring Neuropsychology, psychological distress, quality of life, rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Hospices Civils de Lyon - Groupement hospitalier sud - Hôpital Henry Gabrielle - Service de médecine physique et de réadaptationRecruiting
  • Hôpital Pontchaillou - Service de Médecine Physique et de RéadaptationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group-based cognitive remediation program

One-on-one cognitive remediation program

Arm 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).

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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).
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.

Full Information

First Posted
March 18, 2021
Last Updated
January 12, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04808674
Brief Title
Remediation for Mild Cognitive Deficits After Cancer
Acronym
EURECA
Official Title
EvalUation of REmediation Programs for Patients Suffering From Mild Cognitive Deficits After CAncer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2021 (Actual)
Primary Completion Date
July 17, 2025 (Anticipated)
Study Completion Date
July 17, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Remediation, Breast Cancer
Keywords
Neuropsychology, psychological distress, quality of life, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group-based cognitive remediation program
Arm Type
Experimental
Arm 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).
Arm Title
One-on-one cognitive remediation program
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive remediation program
Intervention Description
Evaluation of REmediation programs for patients suffering from mild cognitive deficits after Cancer
Primary Outcome Measure Information:
Title
Self-reported cognitive function
Description
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).
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Neuropsychological function
Description
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.
Time Frame
16 weeks
Title
Psychological distress
Description
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.
Time Frame
16 weeks
Title
Quality of Life with FACT-B questionnaire
Description
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).
Time Frame
16 weeks
Title
Fatigue
Description
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.
Time Frame
16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie JACQUIN-COURTOIS, PhD
Phone
04.78.86.50.64
Email
sophie.courtois@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mélanie COGNÉ, MD
Phone
02.99.28.42.18
Email
melanie.cogne@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie JACQUIN-COURTOIS, PhD
Organizational Affiliation
Service de médecine physique et de réadaptation, HCL,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon - Groupement hospitalier sud - Hôpital Henry Gabrielle - Service de médecine physique et de réadaptation
City
Lyon
ZIP/Postal Code
69230
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie JACQUIN-COURTOIS, PhD
Phone
0478865064
Email
sophie.courtois@chu-lyon.fr
Facility Name
Hôpital Pontchaillou - Service de Médecine Physique et de Réadaptation
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mélanie Cogné, MD
Phone
0299284218
Email
melanie.cogne@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Isabelle Bonan, PhD
Phone
0299284218
Email
isabelle.bonan@chu-rennes.fr

12. IPD Sharing Statement

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Remediation for Mild Cognitive Deficits After Cancer

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