Can Alternative Treatment Have an Impact on Cervical Dysplasia?

Overview

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?

Full Title of Study: “Can Mindfulness Meditation Limit the Progression and/or Increase the Remission of Cervical Dysplasia?”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: June 2010

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.

Interventions

• Behavioral: Mindfulness meditation
  • Mindfulness meditation
• Other: No meditation
  • Health care services as usual
• Other: Controls
  • No intervention

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

• The degree of cervical dysplasia
  • Time Frame: 6 months after screening

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 23 Years

Maximum Age: 29 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • University of Copenhagen
• Collaborator
  • Danish Cancer Society
• Provider of Information About this Clinical Study
  • John Brodersen, MD, GP, PhD, Associate Professor, Department and Research Unit of G.P., Institute of Public Health, Uni of Copenhagen