search
Back to results

Hypnosis in Treating Hot Flashes in Breast Cancer Survivors

Primary Purpose

Breast Cancer, Cancer Survivor, Hot Flashes

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hot flashes attenuation
hypnotherapy
Sponsored by
Scott and White Hospital & Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Scott and White Cancer InstituteRecruiting

Outcomes

Primary Outcome Measures

Hot flash control by Hot Flash Daily Diary in week 6

Secondary Outcome Measures

Full Information

First Posted
October 14, 2004
Last Updated
September 19, 2013
Sponsor
Scott and White Hospital & Clinic
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00094133
Brief Title
Hypnosis in Treating Hot Flashes in Breast Cancer Survivors
Official Title
Hypnosis for Hot Flashes in Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Scott and White Hospital & Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cancer Survivor, Hot Flashes
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
hot flashes attenuation
Intervention Type
Procedure
Intervention Name(s)
hypnotherapy
Primary Outcome Measure Information:
Title
Hot flash control by Hot Flash Daily Diary in week 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Elkins, PhD
Organizational Affiliation
Scott and White Hospital & Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scott and White Cancer Institute
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Scott and White Cancer Institute
Phone
800-882-4366

12. IPD Sharing Statement

Citations:
PubMed Identifier
18809612
Citation
Elkins G, Marcus J, Stearns V, Perfect M, Rajab MH, Ruud C, Palamara L, Keith T. Randomized trial of a hypnosis intervention for treatment of hot flashes among breast cancer survivors. J Clin Oncol. 2008 Nov 1;26(31):5022-6. doi: 10.1200/JCO.2008.16.6389. Epub 2008 Sep 22.
Results Reference
result

Learn more about this trial

Hypnosis in Treating Hot Flashes in Breast Cancer Survivors

We'll reach out to this number within 24 hrs