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Completed

NCT Number: NCT03420105

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre François Baclesse, Caen, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Other names: sleep tests

HORMONOTHERAPY

Drug

Adjuvant hormone therapy

Primary outcomes

  1. The memory components and memory loss mechanisms by questionnaires

    Time frame: 6 months after the end of radiotherapy

Secondary outcomes

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

    Time frame: 6 months after the end of radiotherapy

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

    Time frame: 6 months after the end of radiotherapy

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

    Time frame: 6 months after the end of radiotherapy

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Acronym: PROSOM-K

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2018
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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