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

Temple University Health System (TUHS)

Status: Completed

Conditions: Precancerous Condition; Cervical Cancer

Treatments: Behavioral: Healthy Lifestyles; Behavioral: Mindfulness-Based Stress Reduction

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00653146

06851 (Other Identifier)

R01CA125069 (U.S. NIH Grant/Contract)

CDR0000590603

Details and patient eligibility

About

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.

Full 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.

Enrollment: 186 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 2 patient groups, including a placebo group

Mindfulness-based stress reduction

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-Based Stress Reduction

Healthy Lifestyles Program

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Healthy Lifestyles