Cervical Cancer Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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