The Effects of MBSR in Improving Immune Response to Human Papillomavirus in Patients With Cervical Dysplasia
NCT ID: NCT00653146
Last Updated: 2016-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
186 participants
INTERVENTIONAL
2007-09-30
2014-07-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
Healthy Lifestyles Program
The Healthy Lifestyles Program includes information on nutrition and physical activity, and meets for 2 hours, once weekly for 8 weeks.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fox Chase Cancer Center
OTHER
Responsible Party
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Carolyn Fang, PhD
Principal Investigator
Principal Investigators
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Carolyn Fang, PhD
Role: PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center
Locations
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Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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06851
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000590603
Identifier Type: -
Identifier Source: org_study_id