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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Limoges

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • sexologist consult

    Other intervention

    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

    Other intervention

    in the cohort called "elsewhere" , patients will be treated according to standards of care, without specific care by a sexologist

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: Cohort called "elsewhere"Sham comparator 1 intervention
Group B: Cohort called "here"Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Month -1

Secondary outcomes

1

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

Time frame
Month 12
2

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

Time frame
Month 12
3

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)

Time frame
Month 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.