Rectal TumorRectSexQolNCT05933122
Study of the Prevalence of Sexual Dysfunction in Women After Rectal Cancer Surgery and Analysis of the Impact of a Sexologist Intervention
A study testing sexologist consult and standart of care in people with Rectal Tumor and Women, run by University Hospital, Limoges at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rectal Tumor, Women, Sexuality
- What is being tested?
- sexologist consult and standart of care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 6 sitesFrance
- Study dates
- 3 Apr 2024to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current pregnancy
- Significant cognitive/psychiatric disorders
- Guardianship
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Brive Hospital
Brive-la-Gaillarde, 19100
Ali Abdeh, MD, Ali.abdeh@ch-brive.fr
Ali Abdeh, MD
- Recruiting
Les cedres Clinical
Brive-la-Gaillarde, 19316
Frederic Bretagnol, MD, frederic.bretagnol@gmail.com
Frederic Bretagnol, MD
- Recruiting
Gueret Hospital
Guéret, 23000
Youssef Souliman, MD, y.souliman@ch-gueret.fr
Youssef Souliman, MD
- Not yet recruiting
Chenieux clinical
Limoges, 87039
Etienne Chuffart, MD, e.chuffart@polyclinique-limoges.fr
Etienne Chuffart, MD
- Recruiting
Limoges University Hospital
Limoges, 87042
Niki Christou, MD, +335 55 05 67 30, christou.niki19@gmail.com
Niki Christou, MD
- Recruiting
Saint Junien Hospital
Saint-Junien, 87200
Denis Valleix, MD, denis.valleix@unilim.fr
Denis Valleix, MD
About this study
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.
Read the 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".
- Conditions
- Rectal Tumor, Women, Sexuality, Life Quality
- Being tested
- sexologist consult, standart of care
- Keywords
- rectal cancer, women, sexuality, quality of life
- Medical subject headings
- Rectal Neoplasms, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
standart of careOther
in the cohort called "elsewhere" , patients will be treated according to standards of care, without specific care by a sexologist
| Study group | Role | What they receive |
|---|---|---|
| Cohort called "elsewhere" | Sham comparator | cohort without specific care by a sexologist Receives: Other: standart of care |
| Cohort called "here" | Experimental | cohort with an intervention by a sexologist Receives: Other: sexologist consult |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: Month 12
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
Measured: 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)
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start3 Apr 2024
- Primary completionMay 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal TumorStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933122
- Sponsor's protocol ID
- 87RI22_0006
- Acronym
- RectSexQol
- Status last verified
- Nov 2024
- First submitted
- 9 Jun 2023
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prevalence of Sexual Dysfunction in Women After Rectal Cancer Surgery and Analysis of the Impact of a Sexologist Intervention
- ClinicalTrials.gov ID
- NCT05933122
- Acronym / sponsor ID
- RectSexQol / 87RI22_0006
- Conditions
- Rectal Tumor, Women, Sexuality, Life Quality
- Keywords
- rectal cancer, women, sexuality, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Cohort called "elsewhere" = cohort without specific care by a sexologist * Cohort called "here" = cohort with an intervention by a sexologist
| Arm | Type | Receives |
|---|---|---|
| Cohort called "elsewhere" | Sham comparator | Other: standart of carecohort without specific care by a sexologist |
| Cohort called "here" | Experimental | Other: sexologist consultcohort with an intervention by a sexologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Current pregnancy
- Significant cognitive/psychiatric disorders
- Guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sexologist consultin 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. | Other | Cohort called "here" |
| standart of carein the cohort called "elsewhere" , patients will be treated according to standards of care, without specific care by a sexologist | Other | Cohort called "elsewhere" |
Primary outcome
Number and proportion of women with sexual dysfunction defined as a total FSFI
Time frame: Month -1
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
3 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
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sexologist consult and standart of care in people with Rectal Tumor and Women, run by University Hospital, Limoges at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niki Christou, MD (+335 55 05 67 30, christou.niki19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and proportion of women with sexual dysfunction defined as a total FSFI (time frame: Month -1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.