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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00653146
First received: April 3, 2008
Last updated: September 2, 2015
Last verified: September 2015
  Purpose

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.


Condition Intervention
Cervical Cancer
Precancerous Condition
Behavioral: Mindfulness-Based Stress Reduction
Behavioral: Healthy Lifestyles

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Mindfulness-Based Stress Reduction (MBSR) on Immune Response to HPV

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of the MBSR and control groups on measures of HPV-specific immune response [ Time Frame: 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 [ Time Frame: baseline, post-intervention, 6 months, and 12 months ] [ Designated as safety issue: No ]
  • Effect of treatment group and process variables on psychosocial well-being [ Time Frame: baseline, post-intervention, 6 months, and 12 months ] [ Designated as safety issue: No ]

Enrollment: 186
Study Start Date: September 2007
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653146

Locations
United States, Pennsylvania
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Carolyn Fang, PhD Fox Chase Cancer Center
  More Information

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00653146     History of Changes
Other Study ID Numbers: CDR0000590603  06851  R01CA125069 
Study First Received: April 3, 2008
Last Updated: September 2, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Fox Chase Cancer Center:
cervical cancer
psychosocial effects of cancer and its treatment
human papilloma virus infection
atypical squamous cells of undetermined significance
low-grade squamous intraepithelial lesion

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Precancerous Conditions
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 25, 2016