Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients
NCT ID: NCT06327607
Last Updated: 2024-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
82 participants
OBSERVATIONAL
2023-06-09
2024-12-31
Brief Summary
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The study is randomized in the two following arms:
Control arm (standard care pathway) Psychosexual intervention arm
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Detailed Description
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The psychosexual intervention aims to improve female sexual functionality and satisfaction by facilitating the understanding of disorders, enabling adequate assessment of possible interventions, and adopting specific treatment exercises.
Patients will be randomized in one of the following two arms:
Control arm (standard care pathway) Psychosexual intervention arm
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Control group
Standard iter of treatment for breast cancer
Control Group
Standard care for breast cancer
Experimental group
Psychosexuological intervention
Psychosexological intervention
The intervention will be conducted individually and will take place once a week for one hour, for a total of 8 consecutive weeks, which must be completed within a maximum duration of 10 weeks.
Interventions
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Control Group
Standard care for breast cancer
Psychosexological intervention
The intervention will be conducted individually and will take place once a week for one hour, for a total of 8 consecutive weeks, which must be completed within a maximum duration of 10 weeks.
Eligibility Criteria
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Inclusion Criteria
* Breast cancer patients undergoing hormonal therapy for at least 6 months in accordance with clinical practice and scientific evidence;
* Pre-menopausal patients (regular menstrual cycles in the last year) before the start of oncological treatments;
* Presence of one or more criteria of sexual dysfunction as per DSM-5;
* Acceptance and signature of the Informed Consent.
Exclusion Criteria
* Presence of psychiatric or neurological conditions that impair the ability to perform the exercises proposed by the research project;
* Already undergoing psycho-sexual counseling;
* Refusal to sign the informed consent
18 Years
FEMALE
No
Sponsors
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European Institute of Oncology
OTHER
Responsible Party
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Principal Investigators
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Gabriella Pravettoni
Role: PRINCIPAL_INVESTIGATOR
European Institute of Oncology
Locations
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European Institute of Oncology
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Gabriella Pravettoni
Role: primary
Other Identifiers
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IEO 1952
Identifier Type: -
Identifier Source: org_study_id
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