Effects of Mindfulness-Based Stress Reduction (MBSR) on Immune Response to HPV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Comparison of indices of psychosocial well-being between the mindfulness-based stress reduction (MBSR) and control groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Mindfulness-Based Stress Reduction (Behavioral)
Healthy Lifestyles Program
The Healthy Lifestyles Program includes information on nutrition and physical activity, and meets for 2 hours, once weekly for 8 weeks.
干预措施: Healthy Lifestyles (Behavioral)
结局指标
主要结局
Comparison of indices of psychosocial well-being between the mindfulness-based stress reduction (MBSR) and control groups
时间窗: baseline, post-intervention, 6 months, and 12 months
次要结局
- Effect of treatment group and process variables on psychosocial well-being(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(baseline, post-intervention, 6 months, and 12 months)
- Comparison of the MBSR and control groups on measures of HPV-specific immune response(baseline, post-intervention, 6 months, and 12 months)
研究者
Carolyn Fang, PhD
Principal Investigator
Fox Chase Cancer Center