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

Not Applicable

Completed

• Conditions: Precancerous Condition; Cervical Cancer
• Interventions: Behavioral: Mindfulness-Based Stress Reduction; Behavioral: Healthy Lifestyles

• Registration Number: NCT00653146
• Lead Sponsor: Fox Chase Cancer Center

Brief 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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 186

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-based stress reduction	Mindfulness-Based Stress Reduction	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.
Healthy Lifestyles Program	Healthy Lifestyles	The Healthy Lifestyles Program includes information on nutrition and physical activity, and meets for 2 hours, once weekly for 8 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Effect of treatment group and process variables on psychosocial well-being	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
Comparison of the MBSR and control groups on measures of HPV-specific immune response	baseline, post-intervention, 6 months, and 12 months

Trial Locations

Locations (2)

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center - Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States