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NCT Number: NCT05933122

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

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.

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Key information

Conditions

Rectal Tumor Behavior Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Life Quality Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms Sexual Behavior Sexuality Women

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brive Hospital, Brive-la-Gaillarde, France

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About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sexologist consult

Other

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

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

Primary outcomes

  1. 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

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

    Time frame: Month 12

    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

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

    Time frame: Month 12

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

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Niki Christou, MD

CONTACT

[email protected]

+335 55 05 67 30

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: RectSexQol

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2023
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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