Assessment of the Quality and Sexual Health Needs of Patients with Advanced-stage Cancer
NCT ID: NCT06229158
Last Updated: 2024-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2024-02-05
2025-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients' group
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).
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.
Partners' of life group
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 under guardians, curators, or legal protection.
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Roxane MD DONZ
Role: primary
Sophie MD FRANCIONI
Role: primary
Roxane MD DONZ
Role: primary
Other Identifiers
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69HCL23_0695
Identifier Type: -
Identifier Source: org_study_id
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