Remediation for Mild Cognitive Deficits After Cancer
EURECA
EvalUation of REmediation Programs for Patients Suffering From Mild Cognitive Deficits After CAncer
2 other identifiers
interventional
24
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2021
CompletedFirst Posted
Study publicly available on registry
March 22, 2021
CompletedStudy Start
First participant enrolled
December 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2025
CompletedJanuary 13, 2023
January 1, 2023
3.6 years
March 18, 2021
January 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Neuropsychological function
16 weeks
Psychological distress
16 weeks
Quality of Life with FACT-B questionnaire
16 weeks
Fatigue
16 weeks
Study Arms (2)
Group-based cognitive remediation program
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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.
Interventions
Evaluation of REmediation programs for patients suffering from mild cognitive deficits after Cancer
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospices Civils de Lyon - Groupement hospitalier sud - Hôpital Henry Gabrielle - Service de médecine physique et de réadaptation
Lyon, 69230, France
Hôpital Pontchaillou - Service de Médecine Physique et de Réadaptation
Rennes, 35000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sophie JACQUIN-COURTOIS, PhD
Service de médecine physique et de réadaptation, HCL,
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2021
First Posted
March 22, 2021
Study Start
December 17, 2021
Primary Completion
July 17, 2025
Study Completion
July 17, 2025
Last Updated
January 13, 2023
Record last verified: 2023-01