Hypnosis in Treating Hot Flashes in Breast Cancer Survivors
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|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||Phase|
|Breast Cancer Cancer Survivor Hot Flashes||Procedure: hot flashes attenuation Procedure: hypnotherapy||Not Applicable|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|