Assessment of the Quality and Sexual Health Needs of Patients with Advanced-stage Cancer

Recruiting

• Conditions: Sexual Satisfaction; Advanced Cancer
• Interventions: Other: Sexual satisfaction questionnaire for patients' life partner; Other: Sexual satisfaction questionnaire for patients

• Registration Number: NCT06229158
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Sexual health is an important determinant of the overall health of a population, as addressed in the French National Strategy 2017-2030. For a long time neglected in oncology, sexual health is now part of clinical assessments in cancer support care and is fully integrated into practice recommendations. However, existing evidences, though limited, are still suggesting unmet needs during the palliative phase of the disease.

Current literature focuses on the assessment and management of potential issues related to genital cancers - primarily gynecological, breast, and prostate cancers - but also on post-cancer experiences. The sexual health needs of patients in palliative care are understudied, except one study that reports how patients are considering sexuality as an important aspect of their lives, even during the last weeks to days of life.

In the aim of developing an efficient complex intervention for the population of patients with cancer in palliative situations, it is necessary to identify the needs, facilitators, and modalities required for promoting sexual health in this population (beyond the extensively studied cases of genital cancers). A solely patient-centred approach would be limiting, and this objective requires an approach dedicated to the life partners as well.

To assess satisfaction related to sexual health and gain insights regarding the expectations of patients and their partners towards the healthcare system, the study INTIMI-K will utilize a mixed methodology involving the use of a questionnaire, including validated scales, and semi-structured interviews. Patients aged 18 and older, diagnosed with advanced solid or hematological cancers, along with their life partner will be included.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-29
• Study Start: 2024-02-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

For patients:

• Individuals aged 18 and older,
• Patients diagnosed with advanced solid or hematological cancers,
• Whether or not undergoing specific treatment for the ongoing oncological condition,
• Having a cancer diagnosis for more than 3 months (baseline diagnosis consultation),
• Capable of understanding study-related documents,
• Capable of completing questionnaires,
• Fluent in French,
• Individuals who have not objected to participating in the study.

For partners:

• Individuals aged 18 and older,
• Individuals whose life partner has been diagnosed with advanced solid or hematological cancer for more than 3 months, whether or not they have received treatment,
• Capable of understanding study-related documents,
• Capable of completing questionnaires,
• Fluent in French,
• Individuals who have not objected to participating in the study.

Exclusion Criteria

• Individuals unable to complete the entire questionnaire due to their clinical condition.
• Individuals under guardians, curators, or legal protection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Partners' of life group	Sexual satisfaction questionnaire for patients' life partner	Partners' of life group of patients' diagnosed with advanced solid or hematological cancers, whether or not undergoing specific treatment for the ongoing oncological condition and having a cancer diagnosis for more than 3 months (baseline diagnosis consultation).
Patients' group	Sexual satisfaction questionnaire for patients	Patients diagnosed with advanced solid or hematological cancers, whether or not undergoing specific treatment for the ongoing oncological condition and having a cancer diagnosis for more than 3 months (baseline diagnosis consultation).

Primary Outcome Measures

Name	Time	Method
Sexual Health satisfaction assessment	Day 1	Average scores for the various questions from the different developed ad-hoc questionnaire to assess satisfaction related to sexual health

Trial Locations

Locations (3)

Centre hospitalier de la Croix Rousse, Hospices Civils de Lyon; 🇫🇷 Lyon, France

Centre Hospitalier Edouard Herriot, Hospices Civils de Lyon; 🇫🇷 Lyon, France

Centre Hospitalier Lyon Sud, Hospices Civils de Lyon; 🇫🇷 Lyon, France