Clinical trial NCT05933122: Study of the Prevalence of Sexual Dysfunction in Women After Rectal Cancer Surgery and Analysis of the Impact of a Sexologist Intervention
Official title: Study of the Prevalence of Sexual Dysfunction in Women After Rectal Cancer Surgery and Analysis of the Impact of a Sexologist Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Tumor
Women
Sexuality
Life Quality
Keywords: rectal cancer
women
sexuality
quality of life
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Cohort called "elsewhere" = cohort without specific care by a sexologist
* Cohort called "here" = cohort with an intervention by a sexologist
Primary purpose: OTHER

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".

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

Primary outcomes:
measure: Number and proportion of women with sexual dysfunction defined as a total FSFI
timeFrame: Month -1
Secondary outcomes:
measure: 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
timeFrame: Month 12
measure: Change in the score of the "satisfaction" dimension of the FSFI scale between Month -1, Month 6 and Month 12
timeFrame: Month 12
measure: 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)
timeFrame: Month 12
Other outcomes:
Locations:
city: Brive-la-Gaillarde
country: France
facility: Brive Hospital
city: Brive-la-Gaillarde
country: France
facility: Les cedres Clinical
city: Guéret
country: France
facility: Gueret Hospital
city: Limoges
country: France
facility: Chenieux clinical
city: Limoges
country: France
facility: Limoges University Hospital
city: Saint-Junien
country: France
facility: Saint Junien Hospital
Study officials:
References: