Trial Title:
Study of the Prevalence of Sexual Dysfunction in Women After Rectal Cancer Surgery and Analysis of the Impact of a Sexologist Intervention
NCT ID:
NCT05933122
Condition:
Rectal Tumor
Women
Sexuality
Life Quality
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
rectal cancer
women
sexuality
quality of life
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
sexologist consult
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.
Arm group label:
Cohort called "here"
Intervention type:
Other
Intervention name:
standart of care
Description:
in the cohort called "elsewhere" , patients will be treated according to standards of
care, without specific care by a sexologist
Arm group label:
Cohort called "elsewhere"
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".
Criteria for 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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Brive Hospital
Address:
City:
Brive-la-Gaillarde
Zip:
19100
Country:
France
Contact:
Last name:
Ali Abdeh, MD
Email:
Ali.abdeh@ch-brive.fr
Investigator:
Last name:
Ali Abdeh, MD
Email:
Principal Investigator
Facility:
Name:
Les cedres Clinical
Address:
City:
Brive-la-Gaillarde
Zip:
19316
Country:
France
Contact:
Last name:
Frederic Bretagnol, MD
Email:
frederic.bretagnol@gmail.com
Investigator:
Last name:
Frederic Bretagnol, MD
Email:
Principal Investigator
Facility:
Name:
Gueret Hospital
Address:
City:
Guéret
Zip:
23000
Country:
France
Contact:
Last name:
Youssef Souliman, MD
Email:
y.souliman@ch-gueret.fr
Investigator:
Last name:
Youssef Souliman, MD
Email:
Principal Investigator
Facility:
Name:
Chenieux clinical
Address:
City:
Limoges
Zip:
87039
Country:
France
Contact:
Last name:
Etienne Chuffart, MD
Email:
e.chuffart@polyclinique-limoges.fr
Investigator:
Last name:
Etienne Chuffart, MD
Email:
Principal Investigator
Facility:
Name:
Limoges University Hospital
Address:
City:
Limoges
Zip:
87042
Country:
France
Contact:
Last name:
Niki Christou, MD
Phone:
+335 55 05 67 30
Email:
christou.niki19@gmail.com
Investigator:
Last name:
Niki Christou, MD
Email:
Principal Investigator
Facility:
Name:
Saint Junien Hospital
Address:
City:
Saint-Junien
Zip:
87200
Country:
France
Contact:
Last name:
Denis Valleix, MD
Email:
denis.valleix@unilim.fr
Investigator:
Last name:
Denis Valleix, MD
Email:
Principal Investigator
Start date:
April 2024
Completion date:
October 2027
Lead sponsor:
Agency:
University Hospital, Limoges
Agency class:
Other
Source:
University Hospital, Limoges
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05933122
