Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT00094133
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:
NCT00094133
Study Brief:
Protocol Section:
NCT00094133