NCT03946579

Brief Summary

The purpose of this study is to assess the quality of life and sexuality during adjuvant chemotherapy in over 65 years old patients with breast cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

October 16, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2022

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

3.2 years

First QC Date

May 7, 2019

Last Update Submit

December 22, 2022

Conditions

Breast Cancer

Keywords

sexual healthquality of lifeadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Assessment of Sexual Health

    assessment with Female sexual functionnal index (FSFI) self questionnaire

    one year

Secondary Outcomes (5)

  • Assessment of Quality of life

    one year

  • Assessment of Body Image

    one year

  • Assessment ofTiredness

    one year

  • Assessment of Anxiety

    one year

  • Assessment of Depression

    one year

Study Arms (1)

Patient treated by adjuvant therapy

OTHER

Self questionnaires of sexual health and quality of life (FSFI, QLQ-C30, BR23, ELD 15, HADS, GDS 15, BIS, FACIT)

Other: self questionnaires

Interventions

self questionnairesOTHER

FSFI, QLQ-C30, BR23, ELD15, HADS, GDS 15, FACIT, BIS

Patient treated by adjuvant therapy

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Women over 65 years of age
  • treatment by adjuvant therapy for breast cancer
  • pTxNxM0
  • in couple or not

You may not qualify if:

  • Inflammatory breast cancer
  • Not sexually active before breast cancer diagnosis
  • Opposition to fill sel questionnaire and collection of the data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU Amiens

Amiens, France

Location

Centre François Baclesse

Caen, France

Location

Centre Henri Becquerel

Rouen, 76000, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Olivier Rigal, MD

    Centre Henri Becquerel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 10, 2019

Study Start

October 16, 2018

Primary Completion

January 14, 2022

Study Completion

January 14, 2022

Last Updated

December 23, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)