Quality of Life and Sexuality in Women With Gynaecologica... | NCT01589406

Studies
Quality of Life and Sexuality in Women With Gynaecological Cancer

NCT01589406

Sponsor

Rambam Health Care Campus

Status

Unknown status

Last Update Posted

May 2, 2012Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Cancer

Interventions

Not provided

Countries

Israel

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

Apr 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

May 2014Estimated

Completion Date

May 2014Estimated

First Submitted Date

Apr 29, 2012

First Submission Date that Met QC Criteria

May 1, 2012

First Posted Date

May 2, 2012Estimated

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

May 1, 2012

Last Update Posted Date

May 2, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Patients with premalignant (CIN3) and malignant cervical cancer will asked to complete questionnaires regarding intimacy (ENRICH) and life adaptation (PAIS) before treatment (surgery or radiotherapy) and after completion of treatment in order to estimate the influence of disease and treatment on quality of life indices.

Detailed Description

no additional information. see above

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group A group B		A:Patients for surgical intervention B:Patients for radiotherapy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life	longitudinal describtion of quality of life during treatment	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women with Gynaecological cancer intended to undergo chemotherapy or surgery

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

women with Gynaecological cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amnon Amit, MD	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Medical Center		Haifa			Israel

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D019529	Sexuality

Ancestor Terms

ID	Term
D012725	Sexual Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided