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

NCT00653146 | Completed

• 3 other identifiers: CDR000059060306851R01CA125069
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Comparison of the MBSR and control groups on measures of HPV-specific immune response

  baseline, post-intervention, 6 months, and 12 months

• 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

• Effect of treatment group and process variables on psychosocial well-being

  baseline, post-intervention, 6 months, and 12 months

Study Arms (2)

Mindfulness-based stress reduction

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based Stress Reduction

Healthy Lifestyles Program

PLACEBO COMPARATOR

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

Behavioral: Healthy Lifestyles

Interventions

Mindfulness-Based Stress Reduction BEHAVIORAL

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.

Also known as: MBSR

Mindfulness-based stress reduction

Healthy Lifestyles BEHAVIORAL

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.

Healthy Lifestyles Program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Precancerous Conditions; Papillomavirus Infections; Atypical Squamous Cells of the Cervix; Squamous Intraepithelial Lesions

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Cervical Dysplasia; Morphological and Microscopic Findings

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Carolyn Fang, PhD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 4, 2008
• Study Start: September 1, 2007
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 5, 2016

Record last verified: 2016-12

Locations

US (2)