Exploration of the Relationship Between Sexual Health and Pain in the Context of Cancer in France (CASEXPA)

July 15, 2025 updated by: University Hospital, Clermont-Ferrand

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1661

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Clermont-Ferrand, France
        • CHU clermont-ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Cancer patients and cancer survivors recruited via cancer patient associations

Description

Inclusion Criteria:

- Declaring themselves to be suffering from or having suffered from cancer recruited as such via appropriate communication systems (patient associations and social networks, etc.)

Exclusion Criteria:

  • No command of the French language
  • Residence outside France (verified with the department of residence in the questionnaire)
  • Patient Companion
  • Protected adult

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
cancer patients and survivors
Individuals who self-identify as cancer patients or cancer survivors
Other: Pain screening
exploration of the relationship between pain and sexual health

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
presence of pain
Time Frame: day 1
BPI-SF questionnaire - Brief Pain Inventory short from (scores from 0 to 10 worse)
day 1
Sexual satisfaction
Time Frame: day 1
SHQ-C22 questionnaire - Sexual Health Questionnaire (Scores from 0 to 100 better)
day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sexual satisfaction
Time Frame: day 1
Visual analog scale (Scores from 0 to 10 better)
day 1
Quality of the sexual health
Time Frame: day 1
SHQ-C22 questionnaire - Sexual Health Questionnaire (Scores from 0 to 100 better to worse depending of the items)
day 1
Pain severity and characteristics
Time Frame: day 1
BPI-SF questionnaire - Brief Pain Inventory short from (scores from 0 to 10 worse)
day 1
Presence of neuropathic pain
Time Frame: day 1
DN4 interview questionnaire - neuropathique pain 4 questions (scores from 0 to 7 worse)
day 1
Presence of migraine
Time Frame: day 1
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))
day 1
Severity of chemotherapy-induced peripheral neuropathy (sensory and motor)
Time Frame: day 1
QLQ-CIPN20 questionnaire - chemotherapy-induced peripheral neuropathy (scores from 0 to 100 worse)
day 1
Assessment of the quality of life
Time Frame: day 1
QLQ-C30 questionnaire - quality of life questionnaire (scores from 0 to 100 better)
day 1
Assessment of the functioning dimensions
Time Frame: day 1
QLQ-C30 questionnaire - quality of life questionnaire (scores from 0 to 100 better)
day 1
Assessment of the severity of symptoms
Time Frame: day 1
QLQ-C30 questionnaire - quality of life questionnaire (scores from 0 to 100 worse)
day 1
Sociodemographic characteristics - age of patients
Time Frame: day 1
age (years)
day 1
Sociodemographic characteristics - gender
Time Frame: day 1
male, female, non binary
day 1
Sociodemographic characteristics - body mass index
Time Frame: day 1
body mass index (kg/m²)
day 1
Sociodemographic characteristics - use of alcohol, tobacco, e-cigarette, cannabis;
Time Frame: day 1
use of alcohol, tobacco, e-cigarette, cannabis (yes / no, yearly, monthly, weekly, daily)
day 1
Sociodemographic characteristics - marital status
Time Frame: day 1
married; Single with occasional partner; Single without occasional partner
day 1
Sociodemographic characteristics - socioprofesional status
Time Frame: day 1
Farmer ; Artisan ; Merchants/entrepreneurs ; White-collar professionals ; Intermediate professions ; Employees ; Workers ; Retirees ; Unemployed individuals
day 1
Sociodemographic characteristics - living area
Time Frame: day 1
French department of living
day 1
Oncological characteristics - past and/or ongoing treatment
Time Frame: day 1
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)
day 1
Oncological characteristics - type of cancer
Time Frame: day 1
Breast ; Prostate ; Pulmonary ; Blood ; Gynecological ; Kidney ; Colorectal ; Others
day 1
Oncological characteristics - date of cancer diagnosis
Time Frame: day 1
date (mm/yyyy)
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David BALAYSSAC, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 27, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RNI 2024 BALAYSSAC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings