Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Supportive care	Active	18 and over	NCI	CHNMC-08029 08029, NCT00748267

Objectives

1. To test the feasibility of hypnosis as a pre-operative intervention for the reduction of surgical- and anesthesia-related symptoms in women undergoing lumpectomy with sentinel node biopsy, mastectomy, or mastectomy with lymph node dissection for locally recurrent breast cancer.
2. To identify the physical symptoms (i.e., pain, nausea, and vomiting) and psychological symptoms (i.e., anxiety and distress) of patients undergoing hypnosis.
3. To determine the length of stay in the Post Anesthesia Care Unit of patients undergoing adjunct hypnosis.
4. To describe patient satisfaction with the hypnosis experience.
5. To determine the effect size and calculate the sample needed for a randomized clinical trial using the results of this study.

Entry Criteria

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

Prior/Concurrent Therapy:

• See Disease Characteristics
• No concurrent reconstruction surgery

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)

Expected Enrollment

Outcomes

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

Outline

Patients undergo a scripted hypnotic intervention over 15 minutes within 1 hour prior to their planned surgical procedure. Upon completion of the intervention, patients proceed to the Preoperative Holding Area of the Surgery and Post Anesthesia Care Unit where they receive the standard of care for lumpectomy with sentinel node biopsy, mastectomy, or mastectomy with lymph node dissection.

Patients undergo collection of demographic information (i.e., age; gender; ethnicity; marital/partnered status; spiritual practice; family members in the home; stress management history; experience with the continuum of imagery/hypnosis practices; perceptions of concentration abilities; and favorite aromas, colors, and scenes from nature) at the time of consent using the Demographic Survey Questionnaire. They also undergo assessment of physical and psychological symptoms (i.e., pain, nausea, vomiting, anxiety, and generalized distress) at baseline (immediately prior to hypnotic induction) and after the intervention (prior to discharge from the Post Anesthesia Care Unit).

Trial Contact Information

Trial Lead Organizations

City of Hope Comprehensive Cancer Center

Michael Lew, MD, Principal investigator		Ph: 626-359-8111; 800-826-4673

U.S.A.
California
	Duarte
	City of Hope Comprehensive Cancer Center
		Kate Kravits, RN, MA	Ph:  800-826-4673

See All Trial Sites

Registry Information
Official Title		Use of Pre-Operative Hypnosis to Reduce Post-Operative Pain and Anesthesia Related Side-Effects
Trial Start Date		2008-08-11
Trial Completion Date		2009-08-11 (estimated)
Registered in ClinicalTrials.gov		NCT00748267
Date Submitted to PDQ		2008-08-15
Information Last Verified		2008-12-07
NCI Grant/Contract Number		CA33572