Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep

NCT03420105 | Completed

• 1 other identifier: PROSOM-K
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

The results of this study will contribute to a better understanding of prospective memory deficit processes in breast cancer in relation to sleep disorders frequently reported in this pathology. In the long term, a better understanding will make it possible to envisage appropriate treatments to compensate for these memory difficulties and to improve the autonomy of the patients.

Conditions

Breast Cancer; Memory Disorders

Outcome Measures

Primary Outcomes (1)

• The memory components and memory loss mechanisms by questionnaires

  6 months after the end of radiotherapy

Secondary Outcomes (3)

• The effect of sleep quality on the recovery of intentions in prospective memory by questionnaires

  6 months after the end of radiotherapy

• The impact of adjuvant hormone therapy on the functioning of prospective memory by questionnaires

  6 months after the end of radiotherapy

• The influence of anxio-depressive factors and fatigue on prospective memory by questionnaires

  6 months after the end of radiotherapy

Study Arms (3)

Group A

OTHER

Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests

Other: Neuropsychological, psycho-pathological and quality of life assessments; Drug: Hormonotherapy

Group B

OTHER

Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests

Other: Neuropsychological, psycho-pathological and quality of life assessments

Healthy volunteers

OTHER

Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests

Other: Neuropsychological, psycho-pathological and quality of life assessments

Interventions

Neuropsychological, psycho-pathological and quality of life assessments OTHER

Patients and Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests

Also known as: sleep tests

Group A; Group B; Healthy volunteers

Hormonotherapy DRUG

Adjuvant hormone therapy

Group A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major patients under the age of 70;
• Patients who have been treated by surgery or radiotherapy for non-metastatic breast cancer
• Radiotherapy completed for about 6 months
• Level of study 3 "end of primary studies" minimum (Barbizet scale);
• French mother tongue;
• Menopausal women for at least 1 year before the selection visit
• Absence of primary cancer of the central nervous system or brain metastases;
• Absence of previous neurological damage;
• Absence of personality disorders and progressive psychiatric pathology;
• Having signed the informed consent to participate in the study.

You may not qualify if:

• Primary cancer other than breast
• Metastatic cancer
• Treated by chemotherapy
• Cognitive function disorders pre-existing to cancer diagnosis
• Patients with paraneoplastic syndrome;
• Evolutionary psychiatric pathology;
• Refusal of participation;
• Patients unable to respond to cognitive tests;
• Drug use or excessive consumption of alcohol.

Sponsors & Collaborators

• Centre Francois Baclesse: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (2)

Centre François Baclesse

Caen, 14076, France

Location

Inserm-Ephe-Unicaen U1077 (

Caen, France

Location

Related Publications (2)

• Elia C, Perrier J, Duivon M, Rehel S, Gernier F, Fernette M, Doidy F, Clochon P, Grellard JM, Christy F, Segura-Djezzar C, Geffrelot J, Emile G, Allouache D, Viader F, Levy C, Joly F, Eustache F, Giffard B. Links between nocturnal hypoxia and cognitive function in breast cancer. Sci Rep. 2025 Nov 27;15(1):42405. doi: 10.1038/s41598-025-26591-z.

  PMID: 41309988 DERIVED

• Duivon M, Perrier J, Joly F, Licaj I, Grellard JM, Clarisse B, Levy C, Fleury P, Madeleine S, Lefevre N, Rauchs G, Lecouvey G, Fraisse F, Viader F, Eustache F, Desgranges B, Giffard B. Impact of breast cancer on prospective memory functioning assessed by virtual reality and influence of sleep quality and hormonal therapy: PROSOM-K study. BMC Cancer. 2018 Sep 3;18(1):866. doi: 10.1186/s12885-018-4762-2.

  PMID: 30176833 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Memory Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 50 patients including: * 25 patients being treated with adjuvant hormone therapy (Group A) * 25 patients not receiving adjuvant hormone therapy (Group B) * 25 healthy volunteers

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: February 5, 2018
• Study Start: January 5, 2018
• Primary Completion: March 6, 2020
• Study Completion: March 6, 2020
• Last Updated: March 9, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)