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

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.

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