Remediation for Mild Cognitive Deficits After Cancer (EURECA)

January 12, 2023 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69230
        • Recruiting
        • Hospices Civils de Lyon - Groupement hospitalier sud - Hôpital Henry Gabrielle - Service de médecine physique et de réadaptation
        • Contact:
      • Rennes, France, 35000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group-based cognitive remediation program
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).
Behavioral: Cognitive remediation program
Evaluation of REmediation programs for patients suffering from mild cognitive deficits after Cancer
Experimental: One-on-one cognitive remediation program
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.
Behavioral: Cognitive remediation program
Evaluation of REmediation programs for patients suffering from mild cognitive deficits after Cancer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-reported cognitive function
Time Frame: 16 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neuropsychological function
Time Frame: 16 weeks
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
Psychological distress
Time Frame: 16 weeks
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
Quality of Life with FACT-B questionnaire
Time Frame: 16 weeks
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
Fatigue
Time Frame: 16 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sophie JACQUIN-COURTOIS, PhD, Service de médecine physique et de réadaptation, HCL,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 17, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 17, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL20_1018
  • 2021-A00798-33 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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