Can Alternative Treatment Have an Impact on Cervical Dysp... | NCT00842738

Studies
Can Alternative Treatment Have an Impact on Cervical Dysplasia?

NCT00842738

Sponsor

University of Copenhagen

Status

Unknown status

Last Update Posted

Jan 14, 2010Estimated

Enrollment

200Estimated

Phase

Phase 4

Conditions

Cervical Dysplasia

Interventions

Mindfulness meditation
No meditation
Controls

Countries

Denmark

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

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Jun 2010Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Feb 10, 2009

First Submission Date that Met QC Criteria

Feb 11, 2009

First Posted Date

Feb 12, 2009Estimated

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

Jan 13, 2010

Last Update Posted Date

Jan 14, 2010Estimated

Name	Class
Danish Cancer Society	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

In this study two questions will be answered:

can mindfulness meditation help cell-changed on the cervix to disappear?
can mindfulness meditation lower the psychological distress when women have abnormal cervical cancer screening results?

Detailed Description

200 women, who have participated in cervical cancer screening and have mild dysplasia, will be randomized into two groups; an intervention group and a control group. The intervention group will be asked to do mindfulness meditation twice a week listening to instructions from a CD. 200 additional women having normal cervical screening results will also be included in the project.

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

Phase 4

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
Mindfulness meditation	Active Comparator	Women with mild dysplasia offered mindfulness meditation	Behavioral: Mindfulness meditation
No meditation	Other	Women with mild dysplasia offered health care services as usual	Other: No meditation
Controls	Other	Women with normal cervical cells	Other: Controls

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness meditation	Behavioral	Mindfulness meditation	Mindfulness meditation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The degree of cervical dysplasia		6 months after screening

Secondary Outcomes

Measure	Description	Time Frame
Psychosocial consequences measured with the COS-CC questionnaire		1 week, 3 and 9 months after screening

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women aged 23-29 years
Participated in cervical cancer screening
Having mild dysplasia and normal screening results

Exclusion Criteria:

Women who have previously had dysplasia

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

23 Years

Maximum Age

29 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department and Research Unit of General Practice, Institute of Public Health		Copenhagen		1014	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D002578	Uterine Cervical Dysplasia
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D002577	Uterine Cervical Diseases
D014591	Uterine Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064866	Mindfulness

Ancestor Terms

ID	Term
D015928	Cognitive Behavioral Therapy
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided