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

Women Clinical Trial

— RectSexQol  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05933122
• Other study ID #: 87RI22_0006
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: October 2027

Study information

• Verified date: June 2023
• Source: University Hospital, Limoges
• Contact: Niki Christou, MD
• Phone: +335 55 05 67 30
• Email: christou.niki19[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: October 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Life Quality
• Rectal Neoplasms
• Rectal Tumor
• Sexuality
• Women

Intervention

Other:
• sexologist consult
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.
• standart of care
in the cohort called "elsewhere" , patients will be treated according to standards of care, without specific care by a sexologist

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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