An observational study in Breast Cancer, sponsored by European Institute of Oncology. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-25.
Sponsored by European Institute of Oncology · Observational
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
The aim of the study is to evaluate the effectiveness of a psychosexual intervention on sexual functioning, mood (levels of depression and anxiety), sleep, and quality of life, compared to standard care pathway. Considering the high incidence of sexual dysfunction in breast cancer patients, this study will focus on this population of patients.
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
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 82 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →European Institute of Oncology is the lead sponsor of 178 studies on the registry; 113 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study is for women who have had breast cancer and are currently undergoing hormonal therapies.
Exclusion Criteria:
Standard iter of treatment for breast cancer
Other: Control Group
Psychosexuological intervention
Other: Psychosexological intervention
Standard care for breast cancer
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.
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.
Time frame: 10 weeks
Evaluation of differences between two arms in levels of quality of life
To measure the differences between the two arms in levels of quality of life investigated using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire.
Time frame: 10 weeks
Evaluation of differences between two arms in levels of anxiety and depression
Levels of anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS).
Time frame: 10 weeks
Evaluation of differences between two arms in levels of sleep quality
Levels of sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) questionnaire.
Time frame: 10 weeks
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European Institute of Oncology