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NCT Number: NCT06229158

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Edouard Herriot, Hospices Civils de Lyon, Lyon, France

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Sexual satisfaction questionnaire for patients

Other

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

Other

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.

Primary outcomes

  1. Sexual Health satisfaction assessment

    Time frame: Day 1

    Average scores for the various questions from the different developed ad-hoc questionnaire to assess satisfaction related to sexual health

Study contacts

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

Anne-Sophie BELMONT

CONTACT

[email protected]

4 78 86 41 95 ext. +33

Roxane MD DONZ

CONTACT

[email protected]

4 78 86 41 48 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: INTIMI-K

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2024
Registry last updated
Nov 7, 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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