NCT06508411

Brief 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,661

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 17, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2025

Completed
Last Updated

July 16, 2025

Status Verified

September 1, 2024

Enrollment Period

9 months

First QC Date

July 8, 2024

Last Update Submit

July 15, 2025

Conditions

Keywords

painneuropathic painsexual healthcancer patientscancer survivors

Outcome Measures

Primary Outcomes (2)

  • presence of pain

    BPI-SF questionnaire - Brief Pain Inventory short from (scores from 0 to 10 worse)

    day 1

  • Sexual satisfaction

    SHQ-C22 questionnaire - Sexual Health Questionnaire (Scores from 0 to 100 better)

    day 1

Secondary Outcomes (19)

  • Sexual satisfaction

    day 1

  • Quality of the sexual health

    day 1

  • Pain severity and characteristics

    day 1

  • Presence of neuropathic pain

    day 1

  • Presence of migraine

    day 1

  • +14 more secondary outcomes

Study Arms (1)

cancer patients and survivors

Individuals who self-identify as cancer patients or cancer survivors

Other: Pain screening

Interventions

exploration of the relationship between pain and sexual health

cancer patients and survivors

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsmale, female, non-binary
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients and cancer survivors recruited via cancer patient associations

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

PainNeoplasmsNeuralgia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • David BALAYSSAC

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 18, 2024

Study Start

September 17, 2024

Primary Completion

June 27, 2025

Study Completion

June 27, 2025

Last Updated

July 16, 2025

Record last verified: 2024-09

Locations