Clinical trial NCT00653146: The Effects of MBSR in Improving Immune Response to Human Papillomavirus in Patients With Cervical Dysplasia
Official title: Effects of Mindfulness-Based Stress Reduction (MBSR) on Immune Response to HPV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Precancerous Condition
Keywords: cervical cancer
psychosocial effects of cancer and its treatment
human papilloma virus infection
atypical squamous cells of undetermined significance
low-grade squamous intraepithelial lesion
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-04-04
Enrollment: 186
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of indices of psychosocial well-being between the mindfulness-based stress reduction (MBSR) and control groups
timeFrame: baseline, post-intervention, 6 months, and 12 months
Secondary outcomes:
measure: Comparison of the MBSR and control groups on measures of HPV-specific immune response
timeFrame: baseline, post-intervention, 6 months, and 12 months
measure: Correlation of variations in psychosocial factors (e.g., perceived stress, cancer-related distress, QOL) between treatment group (MBSR vs. attention control) and immunologic outcomes
timeFrame: baseline, post-intervention, 6 months, and 12 months
measure: Effect of treatment group and process variables on psychosocial well-being
timeFrame: baseline, post-intervention, 6 months, and 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Carolyn Fang, PhD
role: PRINCIPAL_INVESTIGATOR
References: