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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Standard iter of treatment for breast cancer |
| |
| Experimental group | Psychosexuological intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Group | Other | Standard care for breast cancer |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 weeks |
| Evaluation of differences between two arms in levels of anxiety and depression |
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Inclusion Criteria:
Exclusion Criteria:
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The study is for women who have had breast cancer and are currently undergoing hormonal therapies.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriella Pravettoni | Contact | +390257489731 | gabriella.pravettoni@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Gabriella Pravettoni | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Recruiting | Milan | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| 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. |
|
Levels of anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS). |
| 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. | 10 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D008722 | Methods |