Can Alternative Treatment Have an Impact on Cervical Dysplasia?

This study is enrolling participants by invitation only.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842738

Locations
Denmark
Department and Research Unit of General Practice, Institute of Public Health
Copenhagen, Denmark, 1014
Sponsors and Collaborators
University of Copenhagen
Danish Cancer Society
  More 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
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 14, 2014