Cognitive RemediationEURECANCT04808674
Remediation for Mild Cognitive Deficits After Cancer
A study testing Cognitive remediation program in people with Cognitive Remediation and Breast Cancer, run by Hospices Civils de Lyon at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cognitive Remediation, Breast Cancer
- What is being tested?
- Cognitive remediation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Dec 2021to 17 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Hospices Civils de Lyon - Groupement hospitalier sud - Hôpital Henry Gabrielle - Service de médecine physique et de réadaptation
Lyon, 69230
Sophie JACQUIN-COURTOIS, PhD, 0478865064, sophie.courtois@chu-lyon.fr
- Recruiting
Hôpital Pontchaillou - Service de Médecine Physique et de Réadaptation
Rennes, 35000
Mélanie Cogné, MD, 0299284218, melanie.cogne@chu-rennes.fr
Isabelle Bonan, PhD, 0299284218, isabelle.bonan@chu-rennes.fr
About this study
Official title: 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.
- Conditions
- Cognitive Remediation, Breast Cancer
- Being tested
- Cognitive remediation program
- Keywords
- Neuropsychology, psychological distress, quality of life, rehabilitation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive remediation programBehavioural
Evaluation of REmediation programs for patients suffering from mild cognitive deficits after Cancer
| Study group | Role | What they receive |
|---|---|---|
| Group-based cognitive remediation program | Experimental | 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). Receives: Behavioral: Cognitive remediation program |
| One-on-one cognitive remediation program | Experimental | 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. Receives: Behavioral: Cognitive remediation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 16 weeks
Secondary outcomes (4)
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.
Measured: 16 weeks
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.
Measured: 16 weeks
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).
Measured: 16 weeks
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start17 Dec 2021
- Primary completion17 Jul 2025 (estimated)
- Study completion17 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive RemediationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie JACQUIN-COURTOIS, PhD, Principal investigator, Service de médecine physique et de réadaptation, HCL,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808674
- Sponsor's protocol ID
- 69HCL20_1018
- Other IDs
- 2021-A00798-33
- Acronym
- EURECA
- Status last verified
- Jan 2023
- First submitted
- 18 Mar 2021
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EvalUation of REmediation Programs for Patients Suffering From Mild Cognitive Deficits After CAncer
- ClinicalTrials.gov ID
- NCT04808674
- Acronym / sponsor ID
- EURECA / 69HCL20_1018
- Conditions
- Cognitive Remediation, Breast Cancer
- Keywords
- Neuropsychology, psychological distress, quality of life, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 17 Jul 2025 (estimated)
- Study completion
- 17 Jul 2025 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-based cognitive remediation program | Experimental | Behavioral: Cognitive remediation programPatients 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). |
| One-on-one cognitive remediation program | Experimental | Behavioral: Cognitive remediation programPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive remediation programEvaluation of REmediation programs for patients suffering from mild cognitive deficits after Cancer | Behavioural | Group-based cognitive remediation program, One-on-one cognitive remediation program |
Primary outcome
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).
4 secondary outcomes
Neuropsychological function
Time frame: 16 weeks
Psychological distress
Time frame: 16 weeks
Quality of Life with FACT-B questionnaire
Time frame: 16 weeks
Fatigue
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie JACQUIN-COURTOIS, PhD principal investigator
Service de médecine physique et de réadaptation, HCL,
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive remediation program in people with Cognitive Remediation and Breast Cancer, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie JACQUIN-COURTOIS, PhD (04.78.86.50.64, sophie.courtois@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported cognitive function (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.