Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients

NCT06327607 | Recruiting

• 1 other identifier: IEO 1952
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective pilot study on the feasibility and efficacy of a brief psychosexual support intervention in breast cancer patients undergoing hormonal therapies for at least 6 months. The study is randomized in the two following arms: Control arm (standard care pathway) Psychosexual intervention arm

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of differences between two arms in female sexual satisfaction and functionality scores

  Measurement of the differences between the two groups in female sexual satisfaction and functionality scores before and after participation in the psychosexual intervention group, we will use the Brief Index of Sexual Functioning-Woman (BISF-W). This is a self-administered questionnaire specifically designed to assess female sexual functionality and satisfaction.

  10 weeks

Secondary Outcomes (3)

• Evaluation of differences between two arms in levels of quality of life

  10 weeks

• Evaluation of differences between two arms in levels of anxiety and depression

  10 weeks

• Evaluation of differences between two arms in levels of sleep quality

  10 weeks

Study Arms (2)

Control group

Standard iter of treatment for breast cancer

Other: Control Group

Experimental group

Psychosexuological intervention

Other: Psychosexological intervention

Interventions

Control Group OTHER

Standard care for breast cancer

Control group

Psychosexological intervention OTHER

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study is for women who have had breast cancer and are currently undergoing hormonal therapies.

You may qualify if:

• Women with age \>=18 years;
• 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.

You may not qualify if:

• Patients in postmenopausal status;
• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Gabriella Pravettoni

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriella Pravettoni

CONTACT

+390257489731; gabriella.pravettoni@ieo.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: June 9, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

IT (1)