Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-03-02 @ 3:48 PM
Study NCT ID:
NCT00094133
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2004-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypnosis in Treating Hot Flashes in Breast Cancer Survivors
Sponsor:
Scott and White Hospital & Clinic
Organization:
Study Overview
Official Title:
Hypnosis for Hot Flashes in Breast Cancer Survivors
Status:
UNKNOWN
Status Verified Date:
2007-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| S-WHITE-8165 | None | None | View |