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Mindfulness-Based Stress Reduction or General Health Education in Improving Immune Response to Human Papillomavirus in Patients With Cervical Dysplasia
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: April 3, 2008   Last Updated: July 14, 2009   History of Changes
Sponsors and Collaborators: Fox Chase Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00653146
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Comparison of indices of psychosocial well-being between the mindfulness-based stress reduction (MBSR) and control groups at baseline, post-intervention, 6 months, and 12 months [ Designated as safety issue: No ]
  • Comparison of the MBSR and control groups on measures of HPV-specific immune response at baseline, post-intervention, 6 months, and 12 months [ Designated as safety issue: No ]
  • Correlation of variations in psychosocial factors (e.g., perceived stress, cancer-related distress, QOL) between treatment group (MBSR vs. attention control) and immunologic outcomes [ Designated as safety issue: No ]
  • Effect of treatment group and process variables on psychosocial well-being [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2007
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To evaluate the effects of a standardized mindfulness-based stress reduction (MBSR) intervention versus an attention control condition on psychosocial well-being (e.g., perceived stress and quality of life) at post-intervention and subsequent follow-up time points.
  • To evaluate the effects of an MBSR intervention versus an attention control condition on specific immune response to HPV (i.e., T-cell proliferative response to HPV16 and intracellular cytokine expression of HPV-stimulated T-cells) at post-intervention and follow-up time points.
  • To examine the extent to which changes in psychosocial well-being mediate the effects of the intervention on HPV-specific immune response.
  • To explore potential mechanisms of action (e.g., self-regulation, expectancies) that are proposed to be responsible for producing intervention effects on psychosocial well-being.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo a mindfulness-based stress reduction intervention (including meditation techniques, body scan, awareness of breathing, mindful yoga, eating meditation, and walking meditation) for 2 hours, once weekly for 8 weeks.
  • Arm II: Patients undergo general health education on healthy lifestyles for 2 hours, once weekly for 8 weeks. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Referred for a colposcopy following an abnormal Pap smear test result

    • Atypical squamous cells of undetermined significance/positive for human papilloma virus or mild to moderate dysplasia
    • Referred for a second opinion OR patient of record within the medical practice who is undergoing routine recommended follow-up
  • Recruited from Fox Chase Cancer Center or Thomas Jefferson University Hospital
  • No history of cervical cancer
  • No evidence of present invasive carcinoma

PATIENT CHARACTERISTICS:

  • Must be able to read and/or communicate in English
  • Not pregnant
  • No known HIV positivity
  • No psychiatric disorder or other disorder that would preclude informed consent

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653146

Locations
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    
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Principal Investigator: Carolyn Fang, PhD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
cervical cancer
psychosocial effects of cancer and its treatment
human papilloma virus infection
atypical squamous cells of undetermined significance
low-grade squamous intraepithelial lesion

Study placed in the following topic categories:
Virus Diseases
Precancerous Conditions
Stress
Papillomavirus Infections
Papilloma
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:
Neoplasms
Precancerous Conditions

ClinicalTrials.gov processed this record on September 10, 2009