Can Alternative Treatment Have an Impact on Cervical Dysplasia?
This study is enrolling participants by invitation only.
Sponsor:
University of Copenhagen
Collaborator:
Danish Cancer Society
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00842738
First received: February 10, 2009
Last updated: January 13, 2010
Last verified: February 2009
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Purpose
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?
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Dysplasia |
Behavioral: Mindfulness meditation Other: No meditation Other: Controls |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Can Mindfulness Meditation Limit the Progression and/or Increase the Remission of Cervical Dysplasia? |
Resource links provided by NLM:
Further study details as provided by University of Copenhagen:
Primary Outcome Measures:
- The degree of cervical dysplasia [ Time Frame: 6 months after screening ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Psychosocial consequences measured with the COS-CC questionnaire [ Time Frame: 1 week, 3 and 9 months after screening ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Mindfulness meditation
Women with mild dysplasia offered mindfulness meditation
|
Behavioral: Mindfulness meditation
Mindfulness meditation
|
|
No meditation
Women with mild dysplasia offered health care services as usual
|
Other: No meditation
Health care services as usual
|
|
Controls
Women with normal cervical cells
|
Other: Controls
No intervention
|
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.
Eligibility| Ages Eligible for Study: | 23 Years to 29 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | John Brodersen, MD, GP, PhD, Associate Professor, Department and Research Unit of G.P., Institute of Public Health, Uni of Copenhagen |
| ClinicalTrials.gov Identifier: | NCT00842738 History of Changes |
| Other Study ID Numbers: | UP05010 |
| Study First Received: | February 10, 2009 |
| Last Updated: | January 13, 2010 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
Keywords provided by University of Copenhagen:
|
Screening Cervical cancer Cervical dysplasia Adverse psychosocial effects Alternative treatment |
Additional relevant MeSH terms:
|
Uterine Cervical Dysplasia Cervical Intraepithelial Neoplasia Hyperplasia Precancerous Conditions Neoplasms Uterine Cervical Diseases Uterine Diseases |
Genital Diseases, Female Carcinoma in Situ Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013