Hypnosis in Treating Hot Flashes in Breast Cancer Survivors

Not Applicable

• Conditions: Breast Cancer; Cancer Survivor; Hot Flashes

• Registration Number: NCT00094133
• Lead Sponsor: Scott and White Hospital & Clinic

Brief Summary

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.

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 Timeline

• Study First Submitted: 2004-10-14
• Study First Submitted QC: 2004-10-14
• Study First Posted: 2004-10-15
• Study Start: 2006-04
• Status Verified: 2007-09
• Last Update Submitted: 2013-09-19
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hot flash control by Hot Flash Daily Diary in week 6

Trial Locations

Locations (1)

Scott and White Cancer Institute; 🇺🇸 Temple, Texas, United States