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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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 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

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
Intervention / Treatment
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

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

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

University Hospital, Clermont-Ferrand

Investigators

  • 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)

September 17, 2024

Primary Completion (Actual)

June 27, 2025

Study Completion (Actual)

June 27, 2025

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 12, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID 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.

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