Hypnosis in Reducing Pain and Other Side Effects in Women Undergoing Surgery for Breast Cancer

NCT00748267 | Completed DMC

• 4 other identifiers: 08029P30CA033572CHNMC-08029CDR0000612523
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Hypnosis may be effective in reducing pain and other side effects in women undergoing surgery for breast cancer. PURPOSE: This clinical trial is studying how well hypnosis works in reducing pain and other side effects in women undergoing surgery for breast cancer.

Conditions

Anxiety Disorder; Breast Cancer; Nausea and Vomiting; Pain

Keywords

anxiety disorder; pain; nausea and vomiting; breast cancer

Outcome Measures

Primary Outcomes (12)

• Pain as measured by the Condensed Memorial Symptom Assessment Scale (CMSAS)-Modified at baseline (pre-intervention) and prior to discharge from the Post Anesthesia Care Unit

• Nausea as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit

• Vomiting as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit

• Generalized distress as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit

• Anxiety as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit

• Surgical and anesthesia time

• Recovery time

• Medications

• Levels of consciousness

• Standard clinical measures of levels of anesthesia

• Significant surgical events

• Patient satisfaction

Interventions

questionnaire administration OTHER

hypnotherapy PROCEDURE

therapeutic conventional surgery PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of breast cancer * Scheduled for breast surgery (i.e., lumpectomy with sentinel node biopsy, mastectomy, or mastectomy with lymph node dissection) with Dr. Garbaroglio * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * Able to speak and read English * Able to follow instruction * No uncontrolled major comorbid mental conditions (i.e., thought disorders) * No uncontrolled major physical conditions (i.e., untreated congestive heart failure) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent reconstruction surgery

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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Breast Neoplasms; Nausea; Vomiting; Pain

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Michael Lew, MD

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 8, 2008
• Study Start: August 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 7, 2011

Record last verified: 2011-03

Locations

US (1)