Temple, Texas 76508


Purpose:

RATIONALE: Hypnosis may be effective in decreasing hot flashes in breast cancer survivors. PURPOSE: This randomized clinical trial is studying how well hypnosis works in treating hot flashes in breast cancer survivors.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00094133


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Temple, Texas 76508
United States

Clinical Trials Office - Scott and White Cancer Institute
Phone: 800-882-4366

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.