The Effects of MBSR in Improving Immune Response to Human Papillomavirus in Patients With Cervical Dysplasia
|ClinicalTrials.gov Identifier: NCT00653146|
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : December 5, 2016
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 or disease||Intervention/treatment||Phase|
|Cervical Cancer Precancerous Condition||Behavioral: Mindfulness-Based Stress Reduction Behavioral: Healthy Lifestyles||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effects of Mindfulness-Based Stress Reduction (MBSR) on Immune Response to HPV|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
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.
- 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 ]
- Comparison of the MBSR and control groups on measures of HPV-specific immune response [ Time Frame: 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 [ Time Frame: baseline, post-intervention, 6 months, and 12 months ]
- Effect of treatment group and process variables on psychosocial well-being [ Time Frame: baseline, post-intervention, 6 months, and 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653146
|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|
|Principal Investigator:||Carolyn Fang, PhD||Fox Chase Cancer Center|