|No phase specified||Behavioral study, Biomarker/Laboratory analysis, Educational/Counseling/Training||Active||18 and over||NCI, Other||CDR0000590603|
FCCC-06851, 06-851, NCT00653146
RATIONALE: Mindfulness-based stress reduction may affect a patient's feeling of stress and quality of life. It is not yet known whether mindfulness-based stress reduction or health education is effective in improving immune response to human papillomavirus in patients with cervical dysplasia.
PURPOSE: This randomized clinical trial is studying mindfulness-based stress reduction to see how well it works compared with general health education in improving immune response to human papillomavirus in patients with cervical dysplasia.
Further Study Information
- To evaluate the effects of a standardized mindfulness-based stress reduction (MBSR) intervention versus an attention control condition 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 an attention control condition 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 general health education on healthy lifestyles for 2 hours, once weekly for 8 weeks.
In both arms, questionnaire packets measuring psychosocial measures, 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.
- 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
- 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
Trial Lead Organizations/Sponsors
Fox Chase Cancer Center - PhiladelphiaNational Cancer Institute
|Carolyn Fang||Principal Investigator|
|Fox Chase Cancer Center - Philadelphia|
|Clinical Trials Office - Fox Chase Cancer Center - Philadelphi||Ph: 215-728-4790|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia|
|Contact Person||Ph: 215-955-1376|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00653146
Information obtained from ClinicalTrials.gov on November 20, 2012
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