NCT03395327

Brief Summary

The 2014-2019 cancer plan emphasizes the need to "reduce the impact of cancer on personal life". The impact of cancer on sexuality is multifactorial: fatigue, anxiety, impaired body image, chemotherapy treatment. None of these studies specifically assessed the early impact on the quality of sexual life of patients. The purpose of this study is to describe to describe the early evolution of the quality of sexual life of patients receiving adjuvant hormone therapy for breast cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 4, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 20, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

January 4, 2018

Last Update Submit

March 28, 2019

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • score FSFI (Female Sexual Function Index)

    3 month after adjuvant hormone therapy

Interventions

quality of life questionnaireOTHER

QLQ-C30 and BR23 (Quality of Life Questionnaire and Breast 23) Questionnaire FSFI (Female Sexual Function Index)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients managed for localized hormone-sensitive breast cancer but not receiving adjuvant chemotherapy.

You may qualify if:

  • Age greater than or equal to 18 years
  • Female gender
  • Histologically proven non-metastatic breast cancer
  • Indication of adjuvant hormone therapy
  • Patient able to understand a newsletter and to agree to participate

You may not qualify if:

  • Age under 18 years
  • Pregnant woman
  • Adjuvant chemotherapy
  • Patient followed for heavy psychiatric pathology (requiring guardianship or trusteeship)
  • Persons protected or deprived of their liberty
  • Male

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHD Vendée

La Roche-sur-Yon, 85925, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Lucie AUZANNEAU

CONTACT

02 51 44 63 80lucie.auzanneau@chd-vendee.fr

Study Design

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

Study Record Dates

First Submitted

January 4, 2018

First Posted

January 10, 2018

Study Start

February 20, 2018

Primary Completion

February 19, 2020

Study Completion

May 15, 2020

Last Updated

March 29, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)