Study of the Prevalence of Sexual Dysfunction in Women After Rectal Cancer Surgery and Analysis of the Impact of a Sexologist Intervention

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Study of the Prevalence of Sexual Dysfunction in Women After Rectal Cancer Surgery and Analysis of the Impact of a Sexologist Intervention

Conditions
-----------------
Rectal Tumor, Women, Sexuality, Life Quality

Intervention / Treatment
-----------------
* Other: sexologist consult
* Other: standart of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women Diagnosis of stage I-III rectal adenocarcinoma or rectosigmoid junction with anastomosis less than 15 cm from the anal margin Surgical management, preceded or not by Radio-chemotherapy, with restoration of continuity Age : over 18 Proficiency in French or English Exclusion Criteria: Current pregnancy Significant cognitive/psychiatric disorders Guardianship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cohort called elsewhere = cohort without specific care by a sexologist Cohort called here = cohort with an intervention by a sexologist
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Cohort called elsewhere<br>cohort without specific care by a sexologist | Other: standart of care<br>* in the cohort called elsewhere , patients will be treated according to standards of care, without specific care by a sexologist<br>|
| Experimental: Cohort called here<br>cohort with an intervention by a sexologist | Other: sexologist consult<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rectal cancer, women, sexuality, quality of life