Hypnosis in Treating Hot Flashes in Breast Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hypnosis for Hot Flashes in Breast Cancer Survivors

Conditions
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Breast Cancer, Cancer Survivor, Hot Flashes

Intervention / Treatment
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* Procedure: hot flashes attenuation
* Procedure: hypnotherapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: hot flashes attenuation|nan|
|Procedure: hypnotherapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot flash control by Hot Flash Daily Diary in week 6 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer survivor, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, breast cancer in situ, inflammatory breast cancer, hot flashes