View Clinical Trial (Medical Research Study)
Hypnosis in Treating Hot Flashes in Breast Cancer Survivors - NCT00094133-76508(Clinical Trial 122048)
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| City: |
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Temple |
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State:
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TX |
| Zip Code: |
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76508 |
| Conditions: |
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Breast Cancer - Cancer Survivor - Hot Flashes |
| Purpose: |
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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.
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| Study summary: |
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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. |
| 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 |
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| Study is available at: |
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Scott and White Cancer Institute
Temple, TX 76508
United States
Primary Contact:
Clinical Trials Office - Scott and White Cancer Institute
Phone: 800-882-4366 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
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