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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00653146
• Other study ID #: CDR0000590603
• Secondary ID: 06851R01CA125069
• Status: Completed
• Phase: N/A
• First received: April 3, 2008
• Last updated: December 1, 2016
• Start date: September 2007
• Est. completion date: July 2014

Study information

• Verified date: December 2016
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cervical Cancer
• Precancerous Condition
• Precancerous Conditions
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of indices of psychosocial well-being between the mindfulness-based stress reduction (MBSR) and control groups		baseline, post-intervention, 6 months, and 12 months	No
Secondary	Comparison of the MBSR and control groups on measures of HPV-specific immune response		baseline, post-intervention, 6 months, and 12 months	No
Secondary	Correlation of variations in psychosocial factors (e.g., perceived stress, cancer-related distress, QOL) between treatment group (MBSR vs. attention control) and immunologic outcomes		baseline, post-intervention, 6 months, and 12 months	No
Secondary	Effect of treatment group and process variables on psychosocial well-being		baseline, post-intervention, 6 months, and 12 months	No