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RectSexQoL is a study aiming at determining the prevalence of female sexual dysfunction after rectal cancer surgery. It has the goal as well to analyse the impact of an intervention given by a sexologist to such patients.
The treatment of rectal cancer is multimodal combining surgery, chemotherapy and radiotherapy. Each therapeutic tool may affect the sexual life of treated patients.
The incidence of sexual dysfunction in patients with rectal cancer varies according to literature from 5 to 88%. This may be due to the lack of a common definition relating to sexual dysfunction making it difficult to compare results. On the other hand, it should be noted that all of the work related to sexual dysfunction after treatment for rectal cancer is mainly interested in men. The sexual well-being of women treated for rectal cancer is based on the assessment and management of their sexual functions as well as that of their overall sexual health in a personalized manner. The establishment of a sexology consultation before and after such a surgical procedure could improve the sexual functions as well as the sexual well-being of these women. The main aim of our study is to evaluate the prevalence of sexual dysfunctions at M-1 (before treatment) in the two cohorts "here" and "elsewhere" in the context of surgery for rectal cancer in females. The second aim will be to determine the impact of sexology consultation in the cohort "here" in comparison to the standart cohort without any intervention called "elsewhere".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort called "elsewhere" | Sham Comparator | cohort without specific care by a sexologist |
|
| Cohort called "here" | Experimental | cohort with an intervention by a sexologist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sexologist consult | Other | in the cohort called "here", after the diagnosis of rectal cancer, patients will be seen by a sexologist before any kind of treatment for rectal cancer. Sexual dysfunctions will be assessed by a sexologist. After the surgery of rectal cancer, the sexologist will see them again to assess sexual dysfunctions after such a management of rectal cancer. If there is any discovery of a sexual dysfunction or aggravation of a previous one or alteration of sexual life, the sexologist will help the patients to improve their sexual quality of life. |
| Measure | Description | Time Frame |
|---|---|---|
| Number and proportion of women with sexual dysfunction defined as a total FSFI | Number and proportion of women with sexual dysfunction defined as a total FSFI ("Female Sexual Function Index") score greater than 26.55 at Month -1 (before any treatment) in the context of surgery for rectal cancer | Month -1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number and proportion of women with sexual dysfunction defined as a total FSFI score greater than 26.55 at Month 6 and Month 12 after usual or specific management in the context of surgery for rectal cancer | Number and proportion of women with sexual dysfunction defined as a total FSFI ("Female Sexual Function Index") score greater than 26.55 at Month 6 and Month 12 after usual ("elsewhere" cohort) or specific management (duration of 6 months) ("here" cohort, including consultations by a sexologist supervising the surgical procedure) in the context of surgery for rectal cancer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Niki Christou, MD | Contact | +335 55 05 67 30 | christou.niki19@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brive Hospital | Recruiting | Brive-la-Gaillarde | 19100 | France |
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|
| standart of care | Other | in the cohort called "elsewhere" , patients will be treated according to standards of care, without specific care by a sexologist |
|
| Month 12 |
| Change in the score of the "satisfaction" dimension of the FSFI scale between Month -1, Month 6 and Month 12 | Change in the score of the "satisfaction" dimension of the FSFI scale between Month -1, Month 6 and Month 12 | Month 12 |
| Differences (Month 6 - Month -1 and Month 12 - Month 6) in the score of the "satisfaction" dimension of the FSFI scale (Q14-Q16) between the groups with and without treatment by a sexologist (cohort here vs. elsewhere) | Differences (Month 6 - Month -1 and Month 12 - Month 6) in the score of the "satisfaction" dimension of the FSFI scale (Q14-Q16) between the groups with and without treatment by a sexologist (cohort here vs. elsewhere) | Month 12 |
| Les cedres Clinical | Recruiting | Brive-la-Gaillarde | 19316 | France |
|
| Gueret Hospital | Recruiting | Guéret | 23000 | France |
|
| Chenieux clinical | Not yet recruiting | Limoges | 87039 | France |
|
| Limoges University Hospital | Recruiting | Limoges | 87042 | France |
|
| Saint Junien Hospital | Recruiting | Saint-Junien | 87200 | France |
|
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D019529 | Sexuality |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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