Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094133
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2004-10-14
Brief Title:
Hypnosis in Treating Hot Flashes in Breast Cancer Survivors
Sponsor:
Scott and White Hospital Clinic
Organization:
National Cancer Institute NCI
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 IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S-WHITE-8165 | None | None | None |