Hypnosis in Treating Hot Flashes in Breast Cancer Survivors
|ClinicalTrials.gov Identifier: NCT00094133|
Recruitment Status : Unknown
Verified September 2007 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : October 15, 2004
Last Update Posted : September 20, 2013
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Cancer Survivor Hot Flashes||Procedure: hot flashes attenuation Procedure: hypnotherapy|
- 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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||Hypnosis for Hot Flashes in Breast Cancer Survivors|
|Study Start Date :||April 2006|
- Hot flash control by Hot Flash Daily Diary in week 6
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00094133
|United States, Texas|
|Scott and White Cancer Institute||Recruiting|
|Temple, Texas, United States, 76508|
|Contact: Clinical Trials Office - Scott and White Cancer Institute 800-882-4366|
|Principal Investigator:||Gary Elkins, PhD||Scott and White Hospital & Clinic|