NCT06229158

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Cancer
• Sexual Satisfaction

Interventions

Type	Name	Description
OTHER	Sexual satisfaction questionnaire for patients	Completion by patients of a 28-item ad-hoc questionnaire evaluating their sexual satisfaction, alone or with the help of one of the researchers. Each item is rated using a Likert-type scale from 1 to 5. The maximum score is 140, the minimum score is 28. A low score reflects a good level of sexual satisfaction. Participants who have agreed to take part in the qualitative part of the study will be contacted within a few days of inclusion to arrange an appointment for a semi-structured individual interview.
OTHER	Sexual satisfaction questionnaire for patients' life partner	Completion by the patients' life partner of a 30-item ad-hoc questionnaire evaluating their sexual satisfaction, alone or with the help of one of the researchers. Each item is rated using a Likert-type scale from 1 to 5. The maximum score is 140, the minimum score is 28. A low score reflects a good level of sexual satisfaction. Participants who have agreed to take part in the qualitative part of the study will be contacted within a few days of inclusion to arrange an appointment for a semi-structured individual interview.

Timeline

• Start date: 2024-02-05
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2024-01-29
• Last updated: 2024-11-07

Locations

3 sites across 1 country: France