Breast Cancer, Cancer Survivor, Hot Flashes
Conditions
Keywords
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
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.
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.
Interventions
PROCEDUREhot flashes attenuation
PROCEDUREhypnotherapy
Sponsors
National Cancer Institute (NCI)
Scott and White Hospital & Clinic
Study design
Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hot flash control by Hot Flash Daily Diary in week 6 | — |
Countries
United States
Outcome results
None listed