Mindfulness-Based Stress Reduction or General Health Education in Improving Immune Response to Human Papillomavirus in Patients With Cervical Dysplasia
Recruitment status was Recruiting
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.
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
|Official Title:||Effects of Mindfulness-Based Stress Reduction (MBSR) on Immune Response to HPV|
- 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 ]
|Study Start Date:||September 2007|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
- 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.
|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|