Advanced CancerINTIMI-KNCT06229158
Assessment of the Quality and Sexual Health Needs of Patients with Advanced-stage Cancer
An observational study of Advanced Cancer and Sexual Satisfaction, run by Hospices Civils de Lyon at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Sexual Satisfaction
- What is being tested?
- Sexual satisfaction questionnaire for patients and Sexual satisfaction questionnaire for patients' life partner
- How many people
- 120 participants
- Where
- 3 sitesFrance
- Study dates
- 5 Feb 2024to Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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) and their partner of life.
Who may be able to join
- 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,
Show all 16Show fewer
- 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.
Who cannot join
- Individuals unable to complete the entire questionnaire due to their clinical condition.
- Individuals under guardians, curators, or legal protection.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Centre hospitalier de la Croix Rousse, Hospices Civils de Lyon
Lyon
Roxane MD DONZ
- Recruiting
Centre Hospitalier Edouard Herriot, Hospices Civils de Lyon
Lyon
Sophie MD FRANCIONI
- Recruiting
Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Lyon
Roxane MD DONZ
About this study
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.
Read more
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
- Being tested
- Sexual satisfaction questionnaire for patients, Sexual satisfaction questionnaire for patients' life partner
- Keywords
- sexual health, palliative cancer patients, identification of needs
- Medical subject headings
- Orgasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual satisfaction questionnaire for patientsOther
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 partnerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Sexual satisfaction questionnaire for patients | |
| 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). Receives: Other: Sexual satisfaction questionnaire for patients' life partner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Health satisfaction assessment
Average scores for the various questions from the different developed ad-hoc questionnaire to assess satisfaction related to sexual health
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start5 Feb 2024
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229158
- Sponsor's protocol ID
- 69HCL23_0695
- Acronym
- INTIMI-K
- Status last verified
- Nov 2024
- First submitted
- 19 Jan 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Quality and Sexual Health Needs of Patients with Advanced-stage Cancer
- ClinicalTrials.gov ID
- NCT06229158
- Acronym / sponsor ID
- INTIMI-K / 69HCL23_0695
- Conditions
- Advanced Cancer, Sexual Satisfaction
- Keywords
- sexual health, palliative cancer patients, identification of needs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients' group | – | Other: Sexual satisfaction questionnaire for patientsPatients 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). |
| Partners' of life group | – | Other: Sexual satisfaction questionnaire for patients' life partnerPartners' 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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) and their partner of life.
Key inclusion criteria (16 listed)
- 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,
Key exclusion criteria (2 listed)
- Individuals unable to complete the entire questionnaire due to their clinical condition.
- Individuals under guardians, curators, or legal protection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sexual satisfaction questionnaire for patientsCompletion 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 | Patients' group |
| Sexual satisfaction questionnaire for patients' life partnerCompletion 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. | Other | Partners' of life group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer and Sexual Satisfaction, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roxane MD DONZ (4 78 86 41 48 ext. +33, roxane.donz@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Health satisfaction assessment (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.