Infections

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Rare Diseases

Papilloma

Uterine Cervical Neoplasms

Communicable Diseases

Virus Diseases

Papillomavirus Infections

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

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.

The Healthy Lifestyles Program includes information on nutrition and physical activity, and meets for 2 hours, once weekly for 8 weeks.

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.

Mindfulness-Based Stress Reduction

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.

Healthy Lifestyles

Carolyn Fang, PhD

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.

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

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

National Cancer Institute (NCI)

Fox Chase Cancer Center

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Effects of MBSR in Improving Immune Response to Human Papillomavirus in Patients With Cervical Dysplasia	NCT00653146	Cervical Cancer Precancerous Co...	Mindfulness-Bas... Healthy Lifesty...	18 Years -	Fox Chase Cancer Center
The Effects of MBSR in Improving Immune Response to Human Papillomavirus in Patients With Cervical Dysplasia	NCT00653146	Cervical Cancer Precancerous Co...	Mindfulness-Bas... Healthy Lifesty...	18 Years -	Fox Chase Cancer Center

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