Management of Cognitive Difficulties After Cancer Treatments in Women Treated for Breast Cancer: Feasibility Study (Step 1 of the Cog-Stim Protocol)

Management of Cognitive Difficulties After Cancer Treatments in Women Treated for Breast Cancer: Feasibility Study (Step 1 of the Cog-Stim Protocol): Condition:   Patient With Localized Breast Cancer Who Start Radiotherapy Treatment Intervention:   Other: Cognitive stimulation sessions coupled with Adapted Physical Activity sessions. Sponsors:   Centre Francois Baclesse;   National Cancer Institute, France;   Ligue contre le cancer, France Not yet recruiting (Source: ClinicalTrials.gov)




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Management of Cognitive Difficulties After Cancer Treatments in Women Treated for Breast Cancer: Feasibility Study (Step 1 of the Cog-Stim Protocol) (COG STIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.



ClinicalTrials.gov Identifier: NCT04213365

Recruitment Status  : Not yet recruiting

First Posted  : December 30, 2019

Last Update Posted  : December 30, 2019

See Contacts and Locations

Sponsor:

Centre Francois Baclesse

Collaborators:

National Cancer Institute, France

Ligue contre le cancer, France

Information provided by (Responsible Party):

Centre Francois Baclesse



Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record

Study Description

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Brief Summary:

Our general objective is therefore to study and compare the benefit of several methods of management of cognitive difficulties reported by patients during treatment for breast cancer, among several treatments, offered independently in patients' homes and supervised from a distance: adapted physical activity only, cognitive stimulation only, and adapted physical activity coupled with cognitive stimulation (during separate sessions). Our study will therefore be the first to include a group benefiting from these two management methods, which will make it possible to assess the individual benefit of cognitive stimulation sessions and adapted physical activity but also the benefit of combined sessions.As this type of combined management has never been the subject of a study, and previous studies relating to a single type of management having raised patient adhesion difficulties, it does not seem certain that this type of care is feasible in practice. Before studying its effectiveness, it is therefore essential to check the feasibility and acceptability of such a program combining sessions of adapted physical activity and cognitive stimulation sessions.We will therefore first carry out a feasibility study, longitudinal and monocentric, which will assess the adherence of patients treated for breast cancer to the performance of cognitive stimulation sessions coupled with sessions of adapted physical activity.This feasibility study is a key stage of the Cog-Stim protocol because its results will probably highlight the obstacles to the intervention program, which will allow us to propose adjustments to improve the study design for the following stages of the protocol. (design optimization).



Condition or disease Intervention/treatment Phase

Patient With Localized Breast Cancer Who Start Radiotherapy Treatment

Other: Cognitive stimulation sessions coupled with Adapted Physical Activity sessions.

Not Applicable



Study Design

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Study Type  : Interventional  (Clinical Trial)

Estimated Enrollment  : 20 participants

Intervention Model: Single Group Assignment

Masking: None (Open Label)

Primary Purpose: Other

Official Title: Management of Cognitive Difficulties After Cancer Treatments in Women Treated for Breast Cancer: Feasibility Study (Step 1 of the Cog-Stim Protocol)

Estimated Study Start Date  : January 2020

Estimated Primary Completion Date  : October 2020

Estimated Study Completion Date  : December 2020

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Breast cancer

MedlinePlus related topics: Breast Cancer Exercise and Physical Fitness Health Checkup

U.S. FDA Resources



Arms and Interventions

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Arm Intervention/treatment

cognitive stimulation and adapted physical activity

12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions.

Other: Cognitive stimulation sessions coupled with Adapted Physical Activity sessions.

12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions.







Outcome Measures

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Primary Outcome Measures  :

Patient adherence [ Time Frame: between inclusion and 3 months ]

The proposrtion of patients who will realize cognitive stimulation sessions coupled with sessions of adapted physical activity





Secondary Outcome Measures  :

Proportion of acceptance [ Time Frame: Before inclusion ]

Proportion of patient who accept the participation in the study



Patient satisfaction [ Time Frame: between inclusion and 3 months ]

Satisfaction questionnary





Eligibility Criteria

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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.





Ages Eligible for Study:  18 Months and older   (Child, Adult, Older Adult)

Sexes Eligible for Study:  Female

Accepts Healthy Volunteers:  No

Criteria

Inclusion Criteria:



Patient aged over 18,

Patient with localized breast cancer, starting adjuvant radiotherapy, having or not receiving previous adjuvant chemotherapy, not yet having started hormone therapy,

Patient with a cognitive complaint having a significant impact on her quality of life (FACT

Cog questionnaire, QoL score ≤ percentile 10 by age),

Absence of major cognitive impairment preventing the performance of cognitive tests (compliance with the MoCA score threshold according to the age and educational level of the patient according to GRECOGVASC standards)

Absence of personality disorders and known progressive psychiatric pathology (e.g. schizophrenia),

Absence of symptomatic neurological history (neurological sequelae of a head trauma, stroke with loss of consciousness> 30 min, multiple sclerosis, epilepsy, neurodegenerative pathology, etc.),

Patient with level of education 3 "end of primary education" minimum (Barbizet scale),

Have access to a computer (fixed or portable) equipped with a keyboard, a webcam (or the possibility of connecting one), headphones or speakers; have an internet connection and an e-mail account; be able to use these tools and Equipment,

Mastery of the French language,- Patient who signed the consent to participate in the study.Patients should start the study within the first 15 days of radiation therapy.

Exclusion Criteria:



Abuse of alcohol or drug use,

Severe visual and / or hearing loss,

Patient unable to respond to cognitive tests,

Medical contraindication to the practice of adapted physical activity sessions,

Practice during adapted physical activity sessions or cognitive management in progress,

Patient's refusal to participate,

Patient deprived of liberty or under guardianship,

Patient unable to submit to study monitoring for geographic, social or psychopathological reasons.

Contacts and Locations

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.



Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04213365





Locations

France

centre François Baclesse Not yet recruiting

Caen, France, 14076

Contact: Marie LANGE    +33 2 31 45 50 50    m.lange@baclesse.unicancer.fr 

Contact: Jean-Michel GRELLARD    +33 2 31 45 50 50    jm.grellard@baclesse.unicancer.fr 

Principal Investigator: Christelle LEVY, MD       

Sub-Investigator: George EMILE, MD       

Sub-Investigator: Julien GEFFRELOT, MD       

Sub-Investigator: Carine SEGURA, MD       

Sub-Investigator: Audrey FAVEYRIAL, MD       

Sub-Investigator: Mélanie DOS SANTOS, MD       

Sponsors and Collaborators

Centre Francois Baclesse

National Cancer Institute, France

Ligue contre le cancer, France

More Information

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Responsible Party: Centre Francois Baclesse

ClinicalTrials.gov Identifier: NCT04213365     History of Changes

Other Study ID Numbers: 2019-A02500-57

First Posted: December 30, 2019    Key Record Dates

Last Update Posted: December 30, 2019

Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No

Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Breast Neoplasms

Neoplasms by Site

Neoplasms

Breast Diseases

Skin Diseases





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