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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer, Precancerous Condition

Intervention / Treatment
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* Behavioral: Mindfulness-Based Stress Reduction
* Behavioral: Healthy Lifestyles


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based stress reduction<br>The MBSR program includes meditation techniques, body scan, awareness of breathing, mindful yoga, eating meditation, and walking meditation, and meets for 2 hours, once weekly for 8 weeks. | Behavioral: Mindfulness-Based Stress Reduction<br>* 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.<br>* Other names: MBSR;|
| Placebo Comparator: Healthy Lifestyles Program<br>The Healthy Lifestyles Program includes information on nutrition and physical activity, and meets for 2 hours, once weekly for 8 weeks. | Behavioral: Healthy Lifestyles<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of indices of psychosocial well-being between the mindfulness-based stress reduction (MBSR) and control groups |  | baseline, post-intervention, 6 months, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the MBSR and control groups on measures of HPV-specific immune response |  | baseline, post-intervention, 6 months, and 12 months | 
| Correlation of variations in psychosocial factors (e.g., perceived stress, cancer-related distress, QOL) between treatment group (MBSR vs. attention control) and immunologic outcomes |  | baseline, post-intervention, 6 months, and 12 months | 
| Effect of treatment group and process variables on psychosocial well-being |  | baseline, post-intervention, 6 months, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, psychosocial effects of cancer and its treatment, human papilloma virus infection, atypical squamous cells of undetermined significance, low-grade squamous intraepithelial lesion