Support of the Sexual Health in Oncology | NCT03166774

Studies
Support of the Sexual Health in Oncology

NCT03166774

Sponsor

Fondation Hôpital Saint-Joseph

Status

Withdrawn

Last Update Posted

Aug 9, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Oncology
Sexual Health

Interventions

Program of support of the sexual health

Countries

Not provided

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

Aug 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study stopped because the the project was abandoned.

Expanded Access Info

Start Date

Jun 6, 2016Actual

Primary Completion Date

Jun 6, 2017Actual

Completion Date

Jun 6, 2017Estimated

First Submitted Date

May 24, 2017

First Submission Date that Met QC Criteria

May 24, 2017

First Posted Date

May 25, 2017Actual

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

Aug 8, 2018

Last Update Posted Date

Aug 9, 2018Actual

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

Implementation of sexual health support program in oncology department. This program is organized in 3 axes. One is to inform the side effects of treatment on sexual health.

There is a counselling team (nurse, esthetician,sexologue..etc) to raise the subject with patient and partner .

Finally, the oncologist continue during the treatment to evaluate the benefit of this program and adapt their counselling according to the needs

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patient consulting in oncology ervice		Program of support of the sexual health in oncology by questionnaire	Other: Program of support of the sexual health

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Program of support of the sexual health	Other	Patients included in the study have to answer to a questionnaire	patient consulting in oncology ervice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Benefit of the care measurement program	assessment of data recorded on questionnaire	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patient consulting in oncology service
age > 18 years
accepting to participate

Exclusion Criteria:

Age< 18 years
Refusing to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient followed in oncology

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexandra SCHULTZ, Psychologist	Fondation Hôpital Saint-Joseph	Principal Investigator

Locations

Not provided

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
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided