- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06428279
Survey of Sexual Health in Cancer Patients (S&C)
Sexual Health in Cancer Patients: a Survey and Pilot Study of Psychosexual Therapy as a Non-pharmacological Supportive Care
Sexual health, a vital aspect of the overall human health and a critical component of quality of life, can be negatively affected by cancer and cancer treatments. Although prevalence rates of sexual difficulties vary depending on several factors including primary diagnosis, treatment modality and methods of assessment, estimates rates are reported to range from 40% to 100%. Despite the abundant literature on sexuality and intimacy, communication about sexual health is often absent or inadequate between patients and health care providers. In this context, more research is needed to understand patients' priorities and needs for information about sexuality.
The purpose of this study is to assess the main difficulties faced by patients in their sexual life and to evaluate patient's satisfaction after having followed sessions of psychosexual therapy proposed at Rafaël Institute, France. The survey will be conducted using questionnaires developed specifically for this study. All questions will be coded through a Likert scale from 1 (strongly disagree) to 7 (strongly agree). Responses to each question will be analyzed with higher mean scores (>4) indicating main difficulties faced by patients in their sexual life. Patients will also express their positive or negative state of agreement regarding questions evaluating their satisfaction after following a program of psychosexual therapy. Approximately 200 patients will be invite to participated in this survey after provided oral consent.
Study Overview
Detailed Description
Sexual health, a vital aspect of the overall human health can be negatively affected by cancer and cancer treatments. Sexual dysfunctions affect the quality of life of an individual since sexual health is a critical component of overall quality of life. The World Health Organization (WHO) defines sexual health as "a state of physical, emotional, mental and social well-being in relation to sexuality; and not merely the absence of disease, dysfunction or infirmity". Indeed, regular sexual activity reduces stress, regularizes sleep cycle, and regulates our mental wellbeing as a whole.
Although prevalence rates of sexual difficulties vary among cancer patients and depend on several factors including primary diagnosis, treatment modality and methods of assessment, estimates rates can range from 40% to 100%. For example, in a French national survey focusing on sexual health of patients with colorectal or breast cancer two years after diagnosis, 54% of patients (235 of 435) reported to have a decrease in sexual desire and 61% had a decrease in frequency of intercourse.
Despite these problems have been well documented in the literature and in practice guidelines, many cancer survivors have limited access to high quality information on sexual health. Indeed, communication about sexual health is often absent or inadequate between patients and the medical team. Among barriers reported by health care providers for avoiding discussing this topic are lack of time, insufficient training, absence of awareness about the subject and unavailable access to integrative medicine solutions where they could send their patients. Cultural values, religious beliefs and social norms may also have significant implications.
Recognizing patients' sexual problems can help health care providers to offer appropriate integrative non-pharmacological interventions to different group of patients. In this context, more research is needed to understand patients' priorities and needs for information about sexuality. The purpose of this study is to assess the main difficulties faced by patients in their sexual life and to evaluate patient's satisfaction after having followed sessions of psychosexual therapy proposed at Rafaël Institute, France.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Institut Rafael
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Levallois Perret, Institut Rafael, France, 92300
- Institute Rafaël
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- cancer patients
- adults aged > 18 years old
Exclusion Criteria:
- <18years old
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patients' satisfaction with their sexual lives
Time Frame: 1 month
|
questionnaire
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
identification of the main physiological and psychological difficulties encountered by patients in their sexual lives
Time Frame: 1 month
|
questionnaire
|
1 month
|
|
patients perceived emotions
Time Frame: 1 month
|
questionnaire
|
1 month
|
|
description of the impact of sex therapy sessions on the sexual health of the participants
Time Frame: 1 month
|
questionnaire
|
1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IR-2024-001
- 2024-A00387-40 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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