NCT05933122

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Apr 2024Oct 2027

First Submitted

Initial submission to the registry

June 9, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

April 3, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

3.1 years

First QC Date

June 9, 2023

Last Update Submit

November 27, 2024

Conditions

Rectal TumorWomenSexualityLife Quality

Keywords

rectal cancerwomensexualityquality of life

Outcome Measures

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

    Month -1

Secondary Outcomes (3)

  • 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

    Month 12

  • Change in the score of the "satisfaction" dimension of the FSFI scale between Month -1, Month 6 and Month 12

    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)

    Month 12

Study Arms (2)

Cohort called "elsewhere"

SHAM COMPARATOR

cohort without specific care by a sexologist

Other: standart of care

Cohort called "here"

EXPERIMENTAL

cohort with an intervention by a sexologist

Other: sexologist consult

Interventions

sexologist consultOTHER

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.

Cohort called "here"
standart of careOTHER

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

Cohort called "elsewhere"

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Current pregnancy
  • Significant cognitive/psychiatric disorders
  • Guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Brive Hospital

Brive-la-Gaillarde, 19100, France

RECRUITING

Les cedres Clinical

Brive-la-Gaillarde, 19316, France

RECRUITING

Gueret Hospital

Guéret, 23000, France

RECRUITING

Chenieux clinical

Limoges, 87039, France

NOT YET RECRUITING

Limoges University Hospital

Limoges, 87042, France

RECRUITING

Saint Junien Hospital

Saint-Junien, 87200, France

RECRUITING

MeSH Terms

Conditions

Rectal NeoplasmsSexuality

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesSexual BehaviorBehavior

Central Study Contacts

Niki Christou, MD

CONTACT

+335 55 05 67 30christou.niki19@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: * Cohort called "elsewhere" = cohort without specific care by a sexologist * Cohort called "here" = cohort with an intervention by a sexologist
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2023

First Posted

July 6, 2023

Study Start

April 3, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

December 2, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)