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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06229158
Other study ID # 69HCL23_0695
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 5, 2024
Est. completion date September 13, 2024

Study information

Verified date January 2024
Source Hospices Civils de Lyon
Contact Roxane MD DONZ
Phone 4 78 86 41 48
Email roxane.donz@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date September 13, 2024
Est. primary completion date September 13, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
France 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

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sexual Health satisfaction assessment Average scores for the various questions from the different developed ad-hoc questionnaire to assess satisfaction related to sexual health Day 1
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