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

December 1, 2016 updated by: Carolyn Fang, PhD, Fox Chase Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Philadelphia, Pennsylvania, United States, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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.
Other Names:
  • MBSR
PLACEBO_COMPARATOR: Healthy Lifestyles Program
The Healthy Lifestyles Program includes information on nutrition and physical activity, and meets for 2 hours, once weekly for 8 weeks.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fox Chase Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

April 3, 2008

First Submitted That Met QC Criteria

April 3, 2008

First Posted (ESTIMATE)

April 4, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 5, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000590603
  • 06851 (OTHER: Fox Chase Cancer Center)
  • R01CA125069 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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