Study of the Prevalence of Sexual Dysfunction in Women After Rectal Cancer Surgery and Analysis of the Impact of a Sexologist Intervention (RectSexQol)
Primary Purpose
Rectal Tumor, Women, Sexuality
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sexologist consult
standart of care
Sponsored by
About this trial
This is an interventional other trial for Rectal Tumor focused on measuring rectal cancer, women, sexuality, quality of life
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
Sites / Locations
- Brive Hospital
- Les cedres Clinical
- Gueret Hospital
- Chenieux clinical
- Limoges University Hospital
- Saint Junien Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Cohort called "elsewhere"
Cohort called "here"
Arm Description
cohort without specific care by a sexologist
cohort with an intervention by a sexologist
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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)
Full Information
NCT ID
NCT05933122
First Posted
June 9, 2023
Last Updated
June 27, 2023
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT05933122
Brief Title
Study of the Prevalence of Sexual Dysfunction in Women After Rectal Cancer Surgery and Analysis of the Impact of a Sexologist Intervention
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
February 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Tumor, Women, Sexuality, Life Quality
Keywords
rectal cancer, women, sexuality, quality of life
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort called "elsewhere"
Arm Type
Sham Comparator
Arm Description
cohort without specific care by a sexologist
Arm Title
Cohort called "here"
Arm Type
Experimental
Arm Description
cohort with an intervention by a sexologist
Intervention Type
Other
Intervention Name(s)
sexologist consult
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
standart of care
Intervention Description
in the cohort called "elsewhere" , patients will be treated according to standards of care, without specific care by a sexologist
Primary Outcome Measure Information:
Title
Number and proportion of women with sexual dysfunction defined as a total FSFI
Description
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
Time Frame
Month -1
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
Month 12
Title
Change in the score of the "satisfaction" dimension of the FSFI scale between Month -1, Month 6 and Month 12
Description
Change in the score of the "satisfaction" dimension of the FSFI scale between Month -1, Month 6 and Month 12
Time Frame
Month 12
Title
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)
Description
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)
Time Frame
Month 12
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niki Christou, MD
Phone
+335 55 05 67 30
Email
christou.niki19@gmail.com
Facility Information:
Facility Name
Brive Hospital
City
Brive-la-Gaillarde
ZIP/Postal Code
19100
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Abdeh, MD
Email
Ali.abdeh@ch-brive.fr
First Name & Middle Initial & Last Name & Degree
Ali Abdeh, MD
Facility Name
Les cedres Clinical
City
Brive-la-Gaillarde
ZIP/Postal Code
19316
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic Bretagnol, MD
Email
frederic.bretagnol@gmail.com
First Name & Middle Initial & Last Name & Degree
Frederic Bretagnol, MD
Facility Name
Gueret Hospital
City
Guéret
ZIP/Postal Code
23000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youssef Souliman, MD
Email
y.souliman@ch-gueret.fr
First Name & Middle Initial & Last Name & Degree
Youssef Souliman, MD
Facility Name
Chenieux clinical
City
Limoges
ZIP/Postal Code
87039
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne Chuffart, MD
Email
e.chuffart@polyclinique-limoges.fr
First Name & Middle Initial & Last Name & Degree
Etienne Chuffart, MD
Facility Name
Limoges University Hospital
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niki Christou, MD
Phone
+335 55 05 67 30
Email
christou.niki19@gmail.com
First Name & Middle Initial & Last Name & Degree
Niki Christou, MD
Facility Name
Saint Junien Hospital
City
Saint-Junien
ZIP/Postal Code
87200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis Valleix, MD
Email
denis.valleix@unilim.fr
First Name & Middle Initial & Last Name & Degree
Denis Valleix, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of the Prevalence of Sexual Dysfunction in Women After Rectal Cancer Surgery and Analysis of the Impact of a Sexologist Intervention
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