Back to resultsCan Alternative Treatment Have an Impact on Cervical Dysplasia?
Primary Purpose
Cervical Dysplasia
Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Mindfulness meditation
No meditation
Controls
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Dysplasia focused on measuring Screening, Cervical cancer, Cervical dysplasia, Adverse psychosocial effects, Alternative treatment
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
Sites / Locations
- Department and Research Unit of General Practice, Institute of Public Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Other
Other
Arm Label
Mindfulness meditation
No meditation
Controls
Arm Description
Women with mild dysplasia offered mindfulness meditation
Women with mild dysplasia offered health care services as usual
Women with normal cervical cells
Outcomes
Primary Outcome Measures
The degree of cervical dysplasia
Secondary Outcome Measures
Psychosocial consequences measured with the COS-CC questionnaire
Full Information
NCT ID
NCT00842738
First Posted
February 10, 2009
Last Updated
January 13, 2010
Sponsor
University of Copenhagen
Collaborators
Danish Cancer Society
1. Study Identification
Unique Protocol Identification Number
NCT00842738
Brief Title
Can Alternative Treatment Have an Impact on Cervical Dysplasia?
Official Title
Can Mindfulness Meditation Limit the Progression and/or Increase the Remission of Cervical Dysplasia?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Copenhagen
Collaborators
Danish Cancer Society
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dysplasia
Keywords
Screening, Cervical cancer, Cervical dysplasia, Adverse psychosocial effects, Alternative treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness meditation
Arm Type
Active Comparator
Arm Description
Women with mild dysplasia offered mindfulness meditation
Arm Title
No meditation
Arm Type
Other
Arm Description
Women with mild dysplasia offered health care services as usual
Arm Title
Controls
Arm Type
Other
Arm Description
Women with normal cervical cells
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness meditation
Intervention Description
Mindfulness meditation
Intervention Type
Other
Intervention Name(s)
No meditation
Intervention Description
Health care services as usual
Intervention Type
Other
Intervention Name(s)
Controls
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
The degree of cervical dysplasia
Time Frame
6 months after screening
Secondary Outcome Measure Information:
Title
Psychosocial consequences measured with the COS-CC questionnaire
Time Frame
1 week, 3 and 9 months after screening
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Department and Research Unit of General Practice, Institute of Public Health
City
Copenhagen
ZIP/Postal Code
1014
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Can Alternative Treatment Have an Impact on Cervical Dysplasia?
We'll reach out to this number within 24 hrs