Hypnosis in Treating Hot Flashes in Breast Cancer Survivors

Scott and White Hospital & Clinic

Status: Unknown

Conditions: Breast Cancer; Hot Flashes; Cancer Survivor

Treatments: Procedure: hypnotherapy; Procedure: hot flashes attenuation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00094133

S-WHITE-8165

CDR0000481365

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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