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Hypnosis in Treating Hot Flashes in Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT00094133
Recruitment Status : Unknown
Verified September 2007 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : October 15, 2004
Last Update Posted : September 20, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Cancer Survivor Hot Flashes Procedure: hot flashes attenuation Procedure: hypnotherapy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Hypnosis for Hot Flashes in Breast Cancer Survivors
Study Start Date : April 2006





Primary Outcome Measures :
  1. Hot flash control by Hot Flash Daily Diary in week 6


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00094133


Locations
United States, Texas
Scott and White Cancer Institute Recruiting
Temple, Texas, United States, 76508
Contact: Clinical Trials Office - Scott and White Cancer Institute    800-882-4366      
Sponsors and Collaborators
Scott and White Hospital & Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Gary Elkins, PhD Scott and White Hospital & Clinic

Publications of Results:
ClinicalTrials.gov Identifier: NCT00094133     History of Changes
Obsolete Identifiers: NCT00324337
Other Study ID Numbers: CDR0000481365
S-WHITE-8165
First Posted: October 15, 2004    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: September 2007

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Breast Neoplasms
Hot Flashes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms