About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Current pregnancy
Significant cognitive/psychiatric disorders
Guardianship
Trial design
Parallel
Treatments tested in this trial
sexologist consult
Other interventionin 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
Other interventionin the cohort called "elsewhere" , patients will be treated according to standards of care, without specific care by a sexologist
Treatment groups
Trial outcomes
Primary outcomes
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 outcomes
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)
Sponsors and contacts
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