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

Not Applicable

Recruiting

• Conditions: Life Quality; Rectal Tumor; Women; Sexuality
• Interventions: Other: standart of care; Other: sexologist consult

• Registration Number: NCT05933122
• Lead Sponsor: University Hospital, Limoges

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".

Study Timeline

• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-07-06
• Study Start: 2024-04-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2027-05
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort called "elsewhere"	standart of care	cohort without specific care by a sexologist
Cohort called "here"	sexologist consult	cohort with an intervention by a sexologist

Primary Outcome Measures

Name	Time	Method
Number and proportion of women with sexual dysfunction defined as a total FSFI	Month -1	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

Secondary Outcome Measures

Name	Time	Method
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	Month 12	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
Change in the score of the "satisfaction" dimension of the FSFI scale between Month -1, Month 6 and Month 12	Month 12	Change in the score of the "satisfaction" dimension of the FSFI scale between Month -1, Month 6 and 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)	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)

Trial Locations

Locations (6)

Brive Hospital; 🇫🇷 Brive-la-Gaillarde, France

Les cedres Clinical; 🇫🇷 Brive-la-Gaillarde, France

Gueret Hospital; 🇫🇷 Guéret, France

Chenieux clinical; 🇫🇷 Limoges, France

Limoges University Hospital; 🇫🇷 Limoges, France

Saint Junien Hospital; 🇫🇷 Saint-Junien, France