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

18 Years
Open (Enrolling)
Cervical Cancer, Precancerous Condition, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

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


- To evaluate the effects of a standardized mindfulness-based stress reduction (MBSR)
intervention versus an attention control condition 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 an attention control condition
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

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 general health education on healthy lifestyles for 2 hours,
once weekly for 8 weeks.

In both arms, questionnaire packets measuring psychosocial measures, 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.

Inclusion Criteria


- 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


- 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


- Not specified

Type of Study:


Study Design:


Outcome Measure:

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

Safety Issue:


Principal Investigator

Carolyn Fang, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center



Study ID:




Start Date:

September 2007

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Precancerous Condition
  • Psychosocial Effects of Cancer and Its Treatment
  • cervical cancer
  • psychosocial effects of cancer and its treatment
  • human papilloma virus infection
  • atypical squamous cells of undetermined significance
  • low-grade squamous intraepithelial lesion
  • Uterine Cervical Neoplasms
  • Precancerous Conditions



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