Hypnosis in Treating Hot Flashes in Breast Cancer Survivors
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer, Cancer, Cancer, Hot Flash |
Therapuetic Areas: | Oncology, Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/2/2016 |
Start Date: | April 2006 |
Hypnosis for Hot Flashes in Breast Cancer Survivors
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.
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.
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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