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Sponsors and Collaborators: |
Fox Chase Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00653146 |
RATIONALE: Mindfulness-based stress reduction may affect a patient's feeling of stress and quality of life. It is not yet known whether mindfulness-based stress reduction or health education is effective in improving immune response to human papillomavirus in patients with cervical dysplasia.
PURPOSE: This randomized clinical trial is studying mindfulness-based stress reduction to see how well it works compared with general health education in improving immune response to human papillomavirus in patients with cervical dysplasia.
Condition | Intervention |
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Cervical Cancer Precancerous/Nonmalignant Condition Psychosocial Effects of Cancer and Its Treatment |
Behavioral: behavioral dietary intervention Behavioral: exercise intervention Genetic: polymerase chain reaction Other: biomarker analysis Other: educational intervention Other: flow cytometry Other: immunological diagnostic method Other: questionnaire administration Procedure: meditation therapy Procedure: mind-body intervention procedure Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: yoga therapy |
Study Type: | Observational |
Official Title: | Effects of Mindfulness-Based Stress Reduction (MBSR) on Immune Response to HPV |
Estimated Enrollment: | 300 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Blood is collected for immunologic assays. HPV status and subtype is evaluated in cervical specimens using standard and real-time PCR techniques. Quality of Life is evaluated at baseline, post-intervention, and at 6 and 12 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Referred for a colposcopy following an abnormal Pap smear test result
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Pennsylvania | |
Fox Chase Cancer Center - Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19111-2497 | |
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi 215-728-4790 | |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19107-5541 | |
Contact: Contact Person 215-955-1376 DianeReibel9@aol.com |
Principal Investigator: | Carolyn Fang, PhD | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000590603, FCCC-06851 |
Study First Received: | April 3, 2008 |
Last Updated: | July 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00653146 History of Changes |
Health Authority: | Unspecified |
cervical cancer psychosocial effects of cancer and its treatment human papilloma virus infection atypical squamous cells of undetermined significance low-grade squamous intraepithelial lesion |
Virus Diseases Precancerous Conditions Stress Papillomavirus Infections |
Papilloma Uterine Cervical Dysplasia Cervical Intraepithelial Neoplasia |
Neoplasms Precancerous Conditions |