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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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Cancer-Related Problem/Condition Cervical Cancer Precancerous/Nonmalignant Condition |
Procedure: behavioral dietary intervention Procedure: biomarker analysis Procedure: educational intervention Procedure: exercise intervention Procedure: flow cytometry Procedure: immunological diagnostic method Procedure: meditation therapy Procedure: mind-body intervention procedure Procedure: polymerase chain reaction Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: questionnaire administration 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.
In both arms, questionnaire packets measuring psychosocial measures, demographics, and behavioral risk factors are administered to patients at baseline, within 2 weeks of completing the 8-week programs, and then at 6 and 12 months. Treatment continues in the absence of developing cervical cancer.
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: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00653146 |
Health Authority: | Unspecified |
cervical cancer psychosocial effects/treatment human papilloma virus infection atypical squamous cells of undetermined significance low-grade squamous intraepithelial lesion |
Virus Diseases Precancerous Conditions Cervical intraepithelial neoplasia Stress |
Papillomavirus Infections Papilloma Uterine Cervical Dysplasia Cervical Intraepithelial Neoplasia |
Neoplasms |