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A Mind-Body Intervention for Hot Flash Management

Primary Purpose

Hot Flashes, Postmenopausal Symptoms, Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Administered Hypnosis
Self-Administered White Noise Hypnosis
Sponsored by
Baylor University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hot Flashes focused on measuring Hot Flashes, Postmenopausal Symptoms, Hypnotic Relaxation Therapy, Mind Body, Hypnosis

Eligibility Criteria

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

Inclusion Criteria:

Postmenopausal as defined by one of the following criteria:

  • No menstrual period in the past 12 months
  • Chemical menopause (LHRH antagonists)
  • Surgical Menopause (bilateral oophorectomy)
  • Evidence of menopause status per FSH and estradiol levels per institutional guidelines. Self-reported history of a minimum of 4 hot flashes per day or 28 hot flashes per week at baseline.

Age over 18 years and able to give consent for participation in the study.

Have discontinued other putative therapies for hot flashes for at least one month prior to enrollment (Vitamin E will be allowed)

Women with a diagnosis of DCIS or invasive breast cancer stages 0-III are allowed to participate and may be on endocrine therapy of any kind. If on endocrine therapy, women must be on it for 4 weeks and not expected to stop it during the study. If not on endocrine therapy, participants should not be planning to start during the course of the study. However, unexpected treatment will not require study withdrawal but will be recorded and considered in the analysis.

Exclusion Criteria:

  • Currently receiving other simultaneous treatment for hot flashes (antidepressant use is allowed if being used for mood alterations and participant has been on the antidepressant for at least 3 months with no plans to change dose or antidepressant during this study)
  • Diagnosis of clinical depression or acute anxiety disorder
  • Currently using any Complementary and Alternative Medicine (CAM) treatments for vasomotor symptoms. (This would include soy products and other phytoestrogens, black cohosh, and any mind-body techniques including meditation, yoga, etc.). If any therapies are used for reasons other than hot flashes and hot flash frequency meets inclusion criteria, then woman is eligible)
  • Diagnosis of a serious psychological illness, specifically psychoses, schizophrenia or borderline personality disorder
  • Currently using hypnosis for any reason
  • PHQ-4 score ≥ 9
  • Non-English speaking
  • Women with stage IV breast cancer

Sites / Locations

  • University of Michigan
  • Baylor UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-Administered Hypnosis

Self-Administered White Noise Hypnosis

Arm Description

Self-administered hypnosis will be practiced daily using different audio recordings using the researcher's voice. Participants will practice hypnosis at home after completing the two study sessions.

Self-administered white noise hypnosis will be practiced daily using a white noise recording. Participants will practice hypnosis at home after completing the two consent and education sessions.

Outcomes

Primary Outcome Measures

Hot Flash Daily Diary
A Hot Flash Daily Diary will be used to measure the primary outcome of hot flash score. Participants will be asked to complete the Hot Flash Daily Diary every day for 8 weeks total to measure the daily frequency and severity (mild, moderate, severe, and very severe) of their hot flashes. Each level of severity is given a value and participants will rate the severity of each hot flash as they experience it and record it in their daily diary. A total hot flash score will be calculated for each participant.

Secondary Outcome Measures

Hot Flash Related Daily Interference Scale
This is a 10-item scale that measures hot flash interference. The Hot Flash Related Daily Interference Scale asks respondents to rate the degree on a 0 (not at all) - 10 (very much so) scale that the hot flashes interfere with various daily activities as well as overall enjoyment or quality of life. The total score will range from 0-100. The higher the total score, the more likely hot flashes are interfering with the daily activities.This measure has been shown to be valid and internally consistent with Cronbach's alpha of .96.
Patient-Reported Outcomes Measurement Information System Emotional Distress Anxiety Scale
This 29-item scale measures 5 domains of anxiety: 1) affective, 2)cognitive, 3) somatic, 4) behavioral, and 5) need for treatment. Items are scored on a scale from 1 (never) - 5 (always) with higher scores reflecting more severe anxiety. The total range for this scale is 0-145. This scale has shown excellent convergent and discriminate validity with other measures with a Cronbach's alpha .95.
Pittsburgh Sleep Quality Index
This is a 19-item self-report inventory designed to measure sleep disturbance. The 19 items are grouped into 7 sub-scales: 1) sleep quality; 2) sleep efficiency; 3) daytime dysfunction; 4) sleep latency; 5) sleep disturbances; 6) sleep duration; and 7) use of sleep medication.These seven sub-scales are scored on a scale of 0 (better) - 3 (worse) with higher scores indicating greater sleep pathology. The sub-scales are then added for a combined total score ranging from 0 (better) - 21 (worse). Alphas for the Pittsburgh Sleep Quality Index range from .70 to .80.
Subject Global Impression of Change
This is a 7-point item in which participants rate the change in hot flashes since beginning the study (ranging from 'very much better', 'moderately better', 'a little better', 'about the same', 'a little worse', 'moderately worse', to 'very much worse'). It has been used extensively for determination of minimally clinically significant differences in numerous oncology clinical trials.Four additional investigator-developed questions about satisfaction are included as well as two questions about the use of the audio recordings.
Diurnal Cortisol Rhythm
Saliva will be collected three times a day over two consecutive days at two time points during the study. Participants will be provided specific directions for the collection of saliva upon awakening (before getting out of bed), 30 minutes later (before eating, drinking, or tooth brushing), and finally at bedtime (around 10 pm, also before tooth brushing) and will be given a Saliva Collection Diary with questions to answer about their saliva collection. This procedure is well-established and considered valid for the measurement of diurnal cortisol rhythm.
Measures of Heart Rate Variability
The shift in autonomic balance from sympathetic dominance (stress response) to parasympathetic dominance (relaxation response) is a very likely candidate for the underlying mechanism of the effects of mind-body interventions on vasomotor symptoms. Relatedly, an increasing body of evidence indicates that hot flash events are associated with changes in heart rate variability. The Polar V800, a mobile HRV recording device, will be worn to collect data over a 24-hour natural ambulatory period as well as two supine standardized 6-minute recording during the two days of cortisol collection. The 24hr and 6 min measurements will be completed (each on separate days) at pre and post-trial.
Perceived Stress Scale
This is a 10-item scale that measures the degree to which situations in one's life are appraised as stressful. The scale provides the degree to which individuals find their lives to be unpredictable, uncontrollable, and overloaded, as well as measures the current levels of experienced stress. Items are scored on a scale from 0 (never) - 4(very often) for a total score ranging from 0-40. with higher scores reflecting more perceived stress. This measure has been shown to be valid and internally consistent, with an alpha of .83.
Self-Hypnosis Practice Log
Participants in both groups will be given a log that will be completed daily. The log will provide space to put the date, whether or not the participant listened to their audio recording, the number of times they practiced (with or without the audio recordings), and provide a space for comments about any interruptions or barriers to listening to their assigned recording.

Full Information

First Posted
June 17, 2018
Last Updated
July 30, 2023
Sponsor
Baylor University
Collaborators
National Center for Complementary and Integrative Health (NCCIH), University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03572153
Brief Title
A Mind-Body Intervention for Hot Flash Management
Official Title
Self-Administered Hypnosis Treatment for the Management of Hot Flashes in Women: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor University
Collaborators
National Center for Complementary and Integrative Health (NCCIH), University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The long-term goal of this program of research is to determine safe and effective non-hormonal interventions for menopausal symptoms. The main goal of this study is to evaluate whether self-administered hypnosis can be used to significantly reduce hot flashes more than self-administered white noise hypnosis over 6 weeks of home practice. The investigators are also examining the impact of each hypnosis group on sleep, anxiety, perceived and measured stress, heart rate variability, and daily activities.
Detailed Description
This randomized, two arm clinical trial will evaluate the efficacy of self-administered hypnosis for the treatment of hot flashes in postmenopausal women using a 1:1 randomization schedule. Primary Objective To evaluate the efficacy of the self-administered hypnosis intervention for hot flashes compared to the self-administered white noise hypnosis. Hypothesis 1: Self-administered hypnosis will significantly decrease vasomotor symptoms (hot flash score of frequency and severity) compared to the self-administered white noise hypnosis at 6 weeks. Secondary Objectives To evaluate the efficacy of the self-administered hypnosis compared to self-administered white noise hypnosis for hot flash activity interference, sleep disturbance, anxiety and perception of benefit; with the expectation that there will be significant improvements among participants in the self-administered hypnosis group when compared with the self-administered white noise hypnosis group at 6 weeks. The investigators will also evaluate the effects of self-administered hypnosis compared to the self-administered white noise hypnosis at 12 weeks for all secondary outcomes except perception of benefit. Additionally, mediators (perceived stress, cortisol, and heart rate variability (HRV)) and moderators (hypnotizability and practice adherence) of hot flash reduction will be explored. Hypothesis 2.1: Compared to self-administered white noise hypnosis, the self-administered hypnosis intervention will result in significant improvements in hot flash activity interference, sleep disturbance, and anxiety at 6 and 12 weeks, and perception of benefit at 6 weeks. Hypothesis 2.2 A decrease in perceived stress will be indicated in the self-administered hypnosis group due to the intervention, which will correspond and contribute to further decrease of the hot flash score at 6 and 12 weeks. Hypothesis 2.3 Diurnal salivary cortisol will demonstrate better circadian rhythms (steeper slopes) in those with larger hot flash reductions and in the self-administered hypnosis group compared to participants in the self-administered white noise hypnosis at 6 weeks. Hypothesis 2.4 Self-administration of hypnosis and greater hot flash reductions will result in higher resting and 24-hour parasympathetic activity, reflected as higher HRV at 6 weeks. Hypothesis 2.5 Higher hypnotizability scores and better adherence rates will be associated with greater reductions in hot flash scores in the self-administered hypnosis group. Hypothesis 2.6 Self-administered hypnosis will significantly decrease vasomotor symptoms (hot flash score of frequency and severity) compared to the self-administered white noise hypnosis at 12 weeks. Recruitment Plan Potential participants will be identified in three ways: postcard mailings and invitation letters; physician referrals and IRB approved chart screening; and flyers, advertisements and press releases. Physician referrals will come primarily from cancer centers at University of Michigan Cancer Center Breast Clinic in Ann Arbor, MI, and the Baylor Scott & White Health Center in Waco, TX. At Michigan, key eligibility criteria will be used to identify potential eligible women through the Honest Broker Office. Charts will be further screened, with IRB approval, for eligibility. If eligible, women will be sent an invitation letter where they can opt in or out of being contacted to learn more about the study. In addition, at Michigan, outreach will occur through obstetrics and gynecology, mammography, and internal medicine clinics to enable recruitment of women without a history of breast cancer. Mass mailings and local advertisement may also be used. At Baylor University, a successful and proven method of accrual has been the use of mass mailings and local advertisement (e.g. newspaper, magazines, flyers). Additionally, Dr. Elkins is a medical associate with Baylor Scott & White Health Center, which provides a direct connection with physicians and medical staff who will provide potential referrals. It is expected that each site (Baylor University and University of Michigan) will recruit approximately half of the participants. Accrual will be closely monitored and efforts to randomize an equal number at each site will be made. The study coordinators will provide education about the trial and a consent form for review both by phone and at the baseline/consent session. All other education beyond the baseline data collection will be provided at the second session 7-30 days later. Both sessions will be between 45-60 minutes. Sessions will be held at Dr. Barton's and Dr. Elkin's research offices, which each provide privacy, a recliner, a relaxing environment, and convenient parking.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes, Postmenopausal Symptoms, Breast Cancer
Keywords
Hot Flashes, Postmenopausal Symptoms, Hypnotic Relaxation Therapy, Mind Body, Hypnosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized and either be assigned to the self-hypnosis group or a self-administered white noise hypnosis group.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
232 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-Administered Hypnosis
Arm Type
Experimental
Arm Description
Self-administered hypnosis will be practiced daily using different audio recordings using the researcher's voice. Participants will practice hypnosis at home after completing the two study sessions.
Arm Title
Self-Administered White Noise Hypnosis
Arm Type
Active Comparator
Arm Description
Self-administered white noise hypnosis will be practiced daily using a white noise recording. Participants will practice hypnosis at home after completing the two consent and education sessions.
Intervention Type
Behavioral
Intervention Name(s)
Self-Administered Hypnosis
Intervention Description
Participants will be listening to six 20-minute hypnosis audio recordings with hypnotic induction. Participants will be encouraged to practice daily, and each recording will build on the content of the previous recordings. They will also be provided with booklets of information about hot flashes, including treatment options.
Intervention Type
Behavioral
Intervention Name(s)
Self-Administered White Noise Hypnosis
Intervention Description
Participants will be listening to the same 20-minute white noise audio recordings for 6 weeks and will be encouraged to practice daily.They will also be provided with booklets as well as an audio recording with information about hot flashes including treatment options.
Primary Outcome Measure Information:
Title
Hot Flash Daily Diary
Description
A Hot Flash Daily Diary will be used to measure the primary outcome of hot flash score. Participants will be asked to complete the Hot Flash Daily Diary every day for 8 weeks total to measure the daily frequency and severity (mild, moderate, severe, and very severe) of their hot flashes. Each level of severity is given a value and participants will rate the severity of each hot flash as they experience it and record it in their daily diary. A total hot flash score will be calculated for each participant.
Time Frame
Daily for 8 total weeks
Secondary Outcome Measure Information:
Title
Hot Flash Related Daily Interference Scale
Description
This is a 10-item scale that measures hot flash interference. The Hot Flash Related Daily Interference Scale asks respondents to rate the degree on a 0 (not at all) - 10 (very much so) scale that the hot flashes interfere with various daily activities as well as overall enjoyment or quality of life. The total score will range from 0-100. The higher the total score, the more likely hot flashes are interfering with the daily activities.This measure has been shown to be valid and internally consistent with Cronbach's alpha of .96.
Time Frame
Baseline, 6 & 12-Weeks
Title
Patient-Reported Outcomes Measurement Information System Emotional Distress Anxiety Scale
Description
This 29-item scale measures 5 domains of anxiety: 1) affective, 2)cognitive, 3) somatic, 4) behavioral, and 5) need for treatment. Items are scored on a scale from 1 (never) - 5 (always) with higher scores reflecting more severe anxiety. The total range for this scale is 0-145. This scale has shown excellent convergent and discriminate validity with other measures with a Cronbach's alpha .95.
Time Frame
Baseline, 6 & 12 Weeks
Title
Pittsburgh Sleep Quality Index
Description
This is a 19-item self-report inventory designed to measure sleep disturbance. The 19 items are grouped into 7 sub-scales: 1) sleep quality; 2) sleep efficiency; 3) daytime dysfunction; 4) sleep latency; 5) sleep disturbances; 6) sleep duration; and 7) use of sleep medication.These seven sub-scales are scored on a scale of 0 (better) - 3 (worse) with higher scores indicating greater sleep pathology. The sub-scales are then added for a combined total score ranging from 0 (better) - 21 (worse). Alphas for the Pittsburgh Sleep Quality Index range from .70 to .80.
Time Frame
Baseline, 6, & 12 weeks.
Title
Subject Global Impression of Change
Description
This is a 7-point item in which participants rate the change in hot flashes since beginning the study (ranging from 'very much better', 'moderately better', 'a little better', 'about the same', 'a little worse', 'moderately worse', to 'very much worse'). It has been used extensively for determination of minimally clinically significant differences in numerous oncology clinical trials.Four additional investigator-developed questions about satisfaction are included as well as two questions about the use of the audio recordings.
Time Frame
This will be completed only at 6 weeks.
Title
Diurnal Cortisol Rhythm
Description
Saliva will be collected three times a day over two consecutive days at two time points during the study. Participants will be provided specific directions for the collection of saliva upon awakening (before getting out of bed), 30 minutes later (before eating, drinking, or tooth brushing), and finally at bedtime (around 10 pm, also before tooth brushing) and will be given a Saliva Collection Diary with questions to answer about their saliva collection. This procedure is well-established and considered valid for the measurement of diurnal cortisol rhythm.
Time Frame
Baseline & 6 weeks.
Title
Measures of Heart Rate Variability
Description
The shift in autonomic balance from sympathetic dominance (stress response) to parasympathetic dominance (relaxation response) is a very likely candidate for the underlying mechanism of the effects of mind-body interventions on vasomotor symptoms. Relatedly, an increasing body of evidence indicates that hot flash events are associated with changes in heart rate variability. The Polar V800, a mobile HRV recording device, will be worn to collect data over a 24-hour natural ambulatory period as well as two supine standardized 6-minute recording during the two days of cortisol collection. The 24hr and 6 min measurements will be completed (each on separate days) at pre and post-trial.
Time Frame
Baseline & 6 weeks
Title
Perceived Stress Scale
Description
This is a 10-item scale that measures the degree to which situations in one's life are appraised as stressful. The scale provides the degree to which individuals find their lives to be unpredictable, uncontrollable, and overloaded, as well as measures the current levels of experienced stress. Items are scored on a scale from 0 (never) - 4(very often) for a total score ranging from 0-40. with higher scores reflecting more perceived stress. This measure has been shown to be valid and internally consistent, with an alpha of .83.
Time Frame
Baseline, 6, & 12 weeks
Title
Self-Hypnosis Practice Log
Description
Participants in both groups will be given a log that will be completed daily. The log will provide space to put the date, whether or not the participant listened to their audio recording, the number of times they practiced (with or without the audio recordings), and provide a space for comments about any interruptions or barriers to listening to their assigned recording.
Time Frame
Daily during weeks 1-6 of the intervention and during week 12.
Other Pre-specified Outcome Measures:
Title
Elkins Hypnotizability Scale
Description
This is a 12-item research assistant administered scale for rating hypnotizability in the general population. The total scale ranges from 0-12. Each item is rated pass/fail, with higher scores indicative of greater hypnotizability. This scale has an excellent reliability with a Cronbach's alpha of .94.
Time Frame
At Baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postmenopausal as defined by one of the following criteria: No menstrual period in the past 12 months Chemical menopause (LHRH antagonists) Surgical Menopause (bilateral oophorectomy) Evidence of menopause status per FSH and estradiol levels per institutional guidelines. Self-reported history of a minimum of 4 hot flashes per day or 28 hot flashes per week at baseline. Age over 18 years and able to give consent for participation in the study. Have discontinued other putative therapies for hot flashes for at least one month prior to enrollment (Vitamin E will be allowed) Women with a diagnosis of DCIS or invasive breast cancer stages 0-III are allowed to participate and may be on endocrine therapy of any kind. If on endocrine therapy, women must be on it for 4 weeks and not expected to stop it during the study. If not on endocrine therapy, participants should not be planning to start during the course of the study. However, unexpected treatment will not require study withdrawal but will be recorded and considered in the analysis. Exclusion Criteria: Currently receiving other simultaneous treatment for hot flashes (antidepressant use is allowed if being used for mood alterations and participant has been on the antidepressant for at least 3 months with no plans to change dose or antidepressant during this study) Diagnosis of clinical depression or acute anxiety disorder Currently using any Complementary and Alternative Medicine (CAM) treatments for vasomotor symptoms. (This would include soy products and other phytoestrogens, black cohosh, and any mind-body techniques including meditation, yoga, etc.). If any therapies are used for reasons other than hot flashes and hot flash frequency meets inclusion criteria, then woman is eligible) Diagnosis of a serious psychological illness, specifically psychoses, schizophrenia or borderline personality disorder Currently using hypnosis for any reason PHQ-4 score ≥ 9 Non-English speaking Women with stage IV breast cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Whitney Williams, M.S.
Phone
254-296-0824
Email
Whitney_Williams@baylor.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Gary Elkins, Ph.D.
Phone
254-296-0643
Email
Gary_Elkins@baylor.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Elkins, Ph.D.
Organizational Affiliation
Baylor University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Debra Barton, RN,PhD,FAAN
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Baylor University
City
Waco
State/Province
Texas
ZIP/Postal Code
76798
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Whitney Williams, M.S.
Phone
254-296-0824
Email
Whitney_Williams@baylor.edu
First Name & Middle Initial & Last Name & Degree
Gary Elkins, PhD
Phone
254-296-0643
Email
Gary_Elkins@baylor.edu
First Name & Middle Initial & Last Name & Degree
Gary Elkins, Ph.D.

12. IPD Sharing Statement

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A Mind-Body Intervention for Hot Flash Management

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