PainCASEXPANCT06508411
Exploration of the Relationship Between Sexual Health and Pain in the Context of Cancer in France
An observational study of Pain and Cancer, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The goal of this observational study is to explore the relationship between pain and sexual health in the context of cancer (cancer patients and cancer survivors). The main question it aims to answer is: Does pain interfere with sexual health in cancer patients and cancer survivors? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Cancer, Survivorship
- What is being tested?
- Pain screening
- How many people
- 1,661 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2024to 27 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Cancer patients and cancer survivors recruited via cancer patient associations
Who may be able to join
- Declaring themselves to be suffering from or having suffered from cancer recruited as such via appropriate communication systems (patient associations and social networks, etc.)
Who cannot join
- No command of the French language
- Residence outside France (verified with the department of residence in the questionnaire)
- Patient Companion
- Protected adult
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploration of the Relationship Between Sexual Health and Pain in the Context of Cancer in France: Cross-sectional Study
The goal of this observational study is to explore the relationship between pain and sexual health in the context of cancer (cancer patients and cancer survivors). The main question it aims to answer is:
- Does pain interfere with sexual health in cancer patients and cancer survivors?
Read the detailed description
Participants will be recruited through French cancer patient associations and will be invited to complete an online survey questionnaire, exploring:
- Sexual health and sexual satisfaction
- Pain severity and impact on daily activities
- Neuropathic pain
- Migraine
- Chemotherapy-induced peripheral neuropathy
- Quality of life, functioning, and symptoms
- Anxiety and depression
- Sociodemographic characteristics of patients
- Oncological characteristics
- Conditions
- Pain, Cancer, Survivorship
- Being tested
- Pain screening
- Keywords
- pain, neuropathic pain, sexual health, cancer patients, cancer survivors
- Medical subject headings
- Pain, Neoplasms, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain screeningOther
exploration of the relationship between pain and sexual health
| Study group | Role | What they receive |
|---|---|---|
| cancer patients and survivors | Individuals who self-identify as cancer patients or cancer survivors Receives: Other: Pain screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of pain
BPI-SF questionnaire - Brief Pain Inventory short from (scores from 0 to 10 worse)
Measured: day 1
Sexual satisfaction
SHQ-C22 questionnaire - Sexual Health Questionnaire (Scores from 0 to 100 better)
Measured: day 1
Secondary outcomes (19)
Sexual satisfaction
Visual analog scale (Scores from 0 to 10 better)
Measured: day 1
Quality of the sexual health
SHQ-C22 questionnaire - Sexual Health Questionnaire (Scores from 0 to 100 better to worse depending of the items)
Measured: day 1
Pain severity and characteristics
BPI-SF questionnaire - Brief Pain Inventory short from (scores from 0 to 10 worse)
Measured: day 1
Presence of neuropathic pain
DN4 interview questionnaire - neuropathique pain 4 questions (scores from 0 to 7 worse)
Measured: day 1
Presence of migraine
Items of the International Classification of Headache Disorders (typical headache that lasted 4-72 h without treatment, at least two of four typical headache characteristics (unilateral, pulsatile, pain intensity ≥4/10 on the visual analogue scale for pain, increase in pain with physical activity), at least one of two types of non pain-associated symptoms (nausea and/or vomiting, photophobia, and phonophobia))
Measured: day 1
Severity of chemotherapy-induced peripheral neuropathy (sensory and motor)
QLQ-CIPN20 questionnaire - chemotherapy-induced peripheral neuropathy (scores from 0 to 100 worse)
Measured: day 1
Assessment of the quality of life
QLQ-C30 questionnaire - quality of life questionnaire (scores from 0 to 100 better)
Measured: day 1
Assessment of the functioning dimensions
QLQ-C30 questionnaire - quality of life questionnaire (scores from 0 to 100 better)
Measured: day 1
Assessment of the severity of symptoms
QLQ-C30 questionnaire - quality of life questionnaire (scores from 0 to 100 worse)
Measured: day 1
Sociodemographic characteristics - age of patients
age (years)
Measured: day 1
Sociodemographic characteristics - gender
male, female, non binary
Measured: day 1
Sociodemographic characteristics - body mass index
body mass index (kg/m²)
Measured: day 1
Sociodemographic characteristics - use of alcohol, tobacco, e-cigarette, cannabis;
use of alcohol, tobacco, e-cigarette, cannabis (yes / no, yearly, monthly, weekly, daily)
Measured: day 1
Sociodemographic characteristics - marital status
married; Single with occasional partner; Single without occasional partner
Measured: day 1
Sociodemographic characteristics - socioprofesional status
Farmer ; Artisan ; Merchants/entrepreneurs ; White-collar professionals ; Intermediate professions ; Employees ; Workers ; Retirees ; Unemployed individuals
Measured: day 1
Sociodemographic characteristics - living area
French department of living
Measured: day 1
Oncological characteristics - past and/or ongoing treatment
currently being treated for cancer ; treated for cancer (today in remission and completed cancer treatments) ; treated for cancer (today cancer still present and treatments against cancer stopped)
Measured: day 1
Oncological characteristics - type of cancer
Breast ; Prostate ; Pulmonary ; Blood ; Gynecological ; Kidney ; Colorectal ; Others
Measured: day 1
Oncological characteristics - date of cancer diagnosis
date (mm/yyyy)
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 posted18 Jul 2024
- Study start17 Sep 2024
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Cross-sectional
- Enrolment
- 1,661 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David BALAYSSAC, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508411
- Sponsor's protocol ID
- RNI 2024 BALAYSSAC
- Acronym
- CASEXPA
- Status last verified
- Sep 2024
- First submitted
- 8 Jul 2024
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Relationship Between Sexual Health and Pain in the Context of Cancer in France: Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06508411
- Acronym / sponsor ID
- CASEXPA / RNI 2024 BALAYSSAC
- Conditions
- Pain, Cancer, Survivorship
- Keywords
- pain, neuropathic pain, sexual health, cancer patients, cancer survivors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,661 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 18 Jul 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.
The goal of this observational study is to explore the relationship between pain and sexual health in the context of cancer (cancer patients and cancer survivors). The main question it aims to answer is:
- Does pain interfere with sexual health in cancer patients and cancer survivors?
Detailed description
Participants will be recruited through French cancer patient associations and will be invited to complete an online survey questionnaire, exploring:
- Sexual health and sexual satisfaction
- Pain severity and impact on daily activities
- Neuropathic pain
- Migraine
- Chemotherapy-induced peripheral neuropathy
- Quality of life, functioning, and symptoms
- Anxiety and depression
- Sociodemographic characteristics of patients
- Oncological characteristics
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cancer patients and survivors | – | Other: Pain screeningIndividuals who self-identify as cancer patients or cancer survivors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients and cancer survivors recruited via cancer patient associations
Key inclusion criteria (1 listed)
- Declaring themselves to be suffering from or having suffered from cancer recruited as such via appropriate communication systems (patient associations and social networks, etc.)
Key exclusion criteria (4 listed)
- No command of the French language
- Residence outside France (verified with the department of residence in the questionnaire)
- Patient Companion
- Protected adult
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 |
|---|---|---|
| Pain screeningexploration of the relationship between pain and sexual health | Other | cancer patients and survivors |
Primary outcome
presence of pain
Time frame: day 1
BPI-SF questionnaire - Brief Pain Inventory short from (scores from 0 to 10 worse)
Sexual satisfaction
Time frame: day 1
SHQ-C22 questionnaire - Sexual Health Questionnaire (Scores from 0 to 100 better)
19 secondary outcomes
Sexual satisfaction
Time frame: day 1
Quality of the sexual health
Time frame: day 1
Pain severity and characteristics
Time frame: day 1
Presence of neuropathic pain
Time frame: day 1
Presence of migraine
Time frame: day 1
Severity of chemotherapy-induced peripheral neuropathy (sensory and motor)
Time frame: day 1
Assessment of the quality of life
Time frame: day 1
Assessment of the functioning dimensions
Time frame: day 1
Assessment of the severity of symptoms
Time frame: day 1
Sociodemographic characteristics - age of patients
Time frame: day 1
Sociodemographic characteristics - gender
Time frame: day 1
Sociodemographic characteristics - body mass index
Time frame: day 1
Sociodemographic characteristics - use of alcohol, tobacco, e-cigarette, cannabis;
Time frame: day 1
Sociodemographic characteristics - marital status
Time frame: day 1
Sociodemographic characteristics - socioprofesional status
Time frame: day 1
Sociodemographic characteristics - living area
Time frame: day 1
Oncological characteristics - past and/or ongoing treatment
Time frame: day 1
Oncological characteristics - type of cancer
Time frame: day 1
Oncological characteristics - date of cancer diagnosis
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
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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. This study is not recruiting at the moment.
David BALAYSSAC principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Cancer, run by University Hospital, Clermont-Ferrand at 1 site 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of pain (time frame: day 1). The study lists 2 primary outcomes in all. 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 16 Jul 2025.