Hypnosis in Treating Hot Flashes in Breast Cancer Survivors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00094133
First received: October 14, 2004
Last updated: September 19, 2013
Last verified: September 2007
  Purpose

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 Intervention
Breast Cancer
Cancer Survivor
Hot Flashes
Procedure: hot flashes attenuation
Procedure: hypnotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Hypnosis for Hot Flashes in Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment: 60
Study Start Date: April 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Gary Elkins, PhD Scott and White Hospital & Clinic
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00094133     History of Changes
Obsolete Identifiers: NCT00324337
Other Study ID Numbers: CDR0000481365, S-WHITE-8165
Study First Received: October 14, 2004
Last Updated: September 19, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

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

ClinicalTrials.gov processed this record on September 18, 2014