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Hypnosis for Hot Flashes in Breast Cancer Survivors


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Cancer Survivor, Hot Flashes

Thank you

Trial Information

Hypnosis for 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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Hot flash control by Hot Flash Daily Diary in week 6

Principal Investigator

Gary Elkins, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Scott and White Hospital & Clinic

Authority:

Unspecified

Study ID:

CDR0000481365

NCT ID:

NCT00094133

Start Date:

April 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Cancer Survivor
  • Hot Flashes
  • 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
  • Breast Neoplasms
  • Hot Flashes

Name

Location

Scott and White Cancer InstituteTemple, Texas  76508