Pilot Study Describing the Early Evolution of the Sexual... | NCT03395327

Studies
Pilot Study Describing the Early Evolution of the Sexual Function of Patients Receiving Adjuvant Hormone Therapy for Breast Cancer

NCT03395327

Sponsor

Centre Hospitalier Departemental Vendee

Status

Unknown status

Last Update Posted

Mar 29, 2019Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

quality of life questionnaire

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2018Actual

Primary Completion Date

Feb 19, 2020Estimated

Completion Date

May 15, 2020Estimated

First Submitted Date

Jan 4, 2018

First Submission Date that Met QC Criteria

Jan 4, 2018

First Posted Date

Jan 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2019

Last Update Posted Date

Mar 29, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
quality of life questionnaire	Other	QLQ-C30 and BR23 (Quality of Life Questionnaire and Breast 23) Questionnaire FSFI (Female Sexual Function Index)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
score FSFI (Female Sexual Function Index)		3 month after adjuvant hormone therapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lucie AUZANNEAU	Contact	02 51 44 63 80	+33	lucie.auzanneau@chd-vendee.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHD Vendée	Recruiting	La Roche-sur-Yon		85925	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided