NCT00653146

The Effects of MBSR in Improving Immune Response to Human Papillomavirus in Patients With Cervical Dysplasia

Effects of Mindfulness-Based Stress Reduction (MBSR) on Immune Response to HPV

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Mindfulness-based stress reduction (MBSR) may reduce patient stress and improve quality of life. It is not yet known whether mindfulness-based stress reduction is effective in improving immune response to human papillomavirus in patients with cervical dysplasia. PURPOSE: This randomized clinical trial is studying whether mindfulness-based stress reduction (MBSR) or a general diet and physical activity program has any effects on immune response to human papillomavirus in patients with cervical dysplasia.

Detailed description

OBJECTIVES: * To evaluate the effects of a standardized mindfulness-based stress reduction (MBSR) intervention versus a diet and physical activity program 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 a diet and physical activity program 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 a diet and physical activity program for 2 hours, once weekly for 8 weeks. In both arms, questionnaires measuring psychosocial factors, 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.

Conditions

• Cervical Cancer
• Precancerous Condition

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness-Based Stress Reduction	In the intervention program, a variety of mindfulness meditation techniques will be taught, including the body scan, awareness of breathing, mindful yoga, eating meditation and walking meditation.
BEHAVIORAL	Healthy Lifestyles	In the control condition, information on healthy lifestyles will be presented in a didactic fashion. Session topics include diet and nutrition, physical activity, and healthy behaviors to prevent cardiovascular disease and cancer.

Timeline

• Start date: 2007-09-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2008-04-04
• Last updated: 2016-12-05

Locations

2 sites across 1 country: United States