Hypnosis in Treating Hot Flashes in Breast Cancer Survivors
NCT ID: NCT00094133
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2006-04-30
Brief Summary
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PURPOSE: This randomized clinical trial is studying how well hypnosis works in treating hot flashes in breast cancer survivors.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
Interventions
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hot flashes attenuation
hypnotherapy
Eligibility Criteria
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Inclusion Criteria
* History of primary breast cancer
* No evidence of detectable disease
* At least 14 hot flashes per week for ≥ 1 month by self-reporting
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Female
* Life expectancy \> 6 months
* Menopausal status not specified
* Outpatient status
* No medical or psychiatric condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
* Concurrent antihormonal agents for breast cancer (e.g., tamoxifen or raloxifene) allowed provided the patient has been on them for ≥ 1 month
* No other concurrent hormonal therapy
* No other putative therapies for hot flashes ≥ 1 month prior to study entry
* Concurrent vitamin E allowed
* No other concurrent treatment for hot flashes
* No concurrent cytotoxic chemotherapy
* Not concurrently using hypnosis for any reason
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Scott and White Hospital & Clinic
OTHER
Principal Investigators
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Gary Elkins, PhD
Role: PRINCIPAL_INVESTIGATOR
Scott and White Hospital & Clinic
Locations
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Scott and White Cancer Institute
Temple, Texas, United States
Countries
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Facility Contacts
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Clinical Trials Office - Scott and White Cancer Institute
Role: primary
References
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Elkins G, Marcus J, Stearns V, Perfect M, Rajab MH, Ruud C, Palamara L, Keith T. Randomized trial of a hypnosis intervention for treatment of hot flashes among breast cancer survivors. J Clin Oncol. 2008 Nov 1;26(31):5022-6. doi: 10.1200/JCO.2008.16.6389. Epub 2008 Sep 22.
Other Identifiers
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S-WHITE-8165
Identifier Type: -
Identifier Source: secondary_id
CDR0000481365
Identifier Type: -
Identifier Source: org_study_id
NCT00324337
Identifier Type: -
Identifier Source: nct_alias