Hot flashes attenuation and hypnotherapy in Breast Cancer and Hot Flashes and Cancer Survivor - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Determine the efficacy of hypnosis in controlling hot flashes in women who are breast cancer survivors.
Determine the extent to which hypnotizability is related to the success of the hypnotherapy intervention.

OUTLINE: This is a randomized, controlled study. Patients are stratified according to age, gender, race, and educational background. All patients complete a Hot Flash Daily Diary to record frequency and severity of hot flashes for 1 week. Patients are then randomized to 1 of 2 treatment arms.

Arm I (hypnotherapy): Patients undergo hypnotherapy once a week for 5 weeks. Patients complete the Hot Flash-Related Daily Interference Scale, the Hospital Depression and Anxiety Sub-scale, the CES Depression Scale, and the MOS-Sleep and Sexual Function Scales in week 5 after the last hypnotherapy intervention. Patients also complete another Hot Flash Daily Diary for 1 week in week 6 and are administered the Stanford Hypnotic Clinical Scale in week 7.
Arm II (control): Patients receive no contact for 4 weeks. Patients complete the questionnaires as in arm I in week 5. Patients also complete another Hot Flash Daily Diary for 1 week in week 6 and are administered the Stanford Hypnotic Clinical Scale in week 7.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Texas
  - Temple, Texas, United States, 76508
    - Recruiting
    - Scott and White Cancer Institute
    - Contact:
      
      Clinical Trials Office - Scott and White Cancer Institute
      
      Phone Number: 800-882-4366

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

History of primary breast cancer
- No evidence of detectable disease
At least 14 hot flashes per week for ≥ 1 month by self-reporting
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Female
Life expectancy > 6 months
Menopausal status not specified
Outpatient status
No medical or psychiatric condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Concurrent antihormonal agents for breast cancer (e.g., tamoxifen or raloxifene) allowed provided the patient has been on them for ≥ 1 month
No other concurrent hormonal therapy
No other putative therapies for hot flashes ≥ 1 month prior to study entry
- Concurrent vitamin E allowed
No other concurrent treatment for hot flashes
No concurrent cytotoxic chemotherapy
Not concurrently using hypnosis for any reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Hot flash control by Hot Flash Daily Diary in week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scott and White Hospital & Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Gary Elkins, PhD, Scott and White Hospital & Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Elkins G, Marcus J, Stearns V, Perfect M, Rajab MH, Ruud C, Palamara L, Keith T. Randomized trial of a hypnosis intervention for treatment of hot flashes among breast cancer survivors. J Clin Oncol. 2008 Nov 1;26(31):5022-6. doi: 10.1200/JCO.2008.16.6389. Epub 2008 Sep 22.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Registration Dates

First Submitted

October 14, 2004

First Submitted That Met QC Criteria