Psychosocial Effect of HPV Positivity | NCT01459289

Studies
Psychosocial Effect of HPV Positivity

NCT01459289

Sponsor

The University of Hong Kong

Status

Unknown status

Last Update Posted

Oct 25, 2011Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Human Papillomavirus

Interventions

leaflet
counseling and leaflet

Countries

China

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

Oct 2011

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

Oct 2011

Primary Completion Date

Oct 2013Estimated

Completion Date

Oct 2013Estimated

First Submitted Date

Sep 15, 2011

First Submission Date that Met QC Criteria

Oct 21, 2011

First Posted Date

Oct 25, 2011Estimated

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

Oct 21, 2011

Last Update Posted Date

Oct 25, 2011Estimated

Name	Class
Queen Mary Hospital, Hong Kong	OTHER

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

The use of HPV testing in cervical screening has raised concerns about the effect of a positive HPV result on women's psychological well being. This is a nested psychosocial study of the COCY trial (IRB No. UW 09-377; PI: Prof Hextan Ngan), with the aim to evaluate the psychosocial impact of HPV positivity on Hong Kong Chinese women and the modulating effects of educational intervention on such impact. Potential participants are identified among those who have joint the COCY trial. Participants will be randomized into two groups, namely the control group or intervention group. The control group participants will receive their smear results and an HPV leaflet by post. The intervention group will receive the leaflet and a counseling session on HPV. Self-administered questionnaires will be used to assess participants' psychological condition at the receipt of the smear results and at two months afterward. It is hypothesized that the level of emotional distress measured at smear result notification will be greater than that at two months afterward for all participants. Furthermore, participants in the intervention group will have lower psychological distress than those in the control group at two months after the receipt of their smear results.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
leaflet	Active Comparator		Other: leaflet
counseling	Active Comparator		Other: counseling and leaflet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
leaflet	Other		leaflet
counseling and leaflet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in anxiety to 6 months	Anxiety meausred by the Hospital Anxiety and Depression Scale	Level of anxiety will be measured at the receipt of cervical smear results, and at 2-months and 6-months afterward.

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in depression to 6 months	Depression will be measured by the Hospital Anxiety and Depression Scale	Level of depression will be measured at the receipt of cervical smear results, and at 2-months and 6-months afterward.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ethnic Chinese women who have enrolled in the COCY trial, and whose smear results are normal cytology with HPV positivity
Women who are willing to attend colposcopy
Literate in the Chinese language
Have given a verbal consent to participate in this study

Exclusion Criteria:

Women who are unable to provide a consent to participation.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hextan YS Ngan, MD	Contact	(852)22554265		hysngan@hku.hk

Overall Officials

Name	Affiliation	Role
Hextan YS Ngan, MD	The University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics & Gynaecology, The University of Hong Kong	Recruiting	Hong Kong			China

Intervention Browse Module

MeSH Terms

ID	Term
D003376	Counseling

Ancestor Terms

ID	Term
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities
D003153	Community Health Services
D006296	Health Services

Browse Leaves

Not provided

Browse Branches

Not provided