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Clinical Trial 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.


Clinical Trial 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 Design

Allocation: Randomized, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT00094133
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Recruiting
Phase N/A
Start date April 2006

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