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Passionflower

Hypnotic relaxation will be performed in three sessions, two weeks apart, over 6 weeks. The hypnosis sessions will build on each other in terms of content.

The PMR will consist of progressive tensing and relaxing of the muscles from head to toe to a soothing sound of the participant's choosing.

There are 3 induction scripts that build upon each other, each about 20 minutes in length. The first focuses on relaxation, feelings of wellness, wholeness, strength, and confidence. The second focuses more on body image related to sexuality, sexual desire, passion, and romanticism. The third includes suggestions from the previous inductions, but adds a behavior that the woman chooses to incorporate for the last 2 weeks of the intervention. A digital recording will be provided of the intervention content for home practice.

Hypnotic Relaxation Therapy

Women will be instructed how to do progressive relaxation and will be given the opportunity to ask questions and express concerns. The research therapist will utilize a script to focus the conversation on relaxation and planning the implementation of the behavior. Participants will be given a digital recording of 4 pleasant background sounds to facilitate their relaxation practice. Home practice will be encouraged.

Progressive Muscle Relaxation

Debra Barton, RN, PhD, FAAN

The purpose of this study is to determine if hypnotic relaxation therapy is a more effective intervention for improving self-image in women who have been diagnosed with breast or gynecologic cancer when compared to progressive muscle relaxation therapy.

This will be a phase II randomized controlled trial involving two arms: hypnotic relaxation and progressive muscle relaxation (PMR), using a 2:1 randomization schedule.

1. Evaluate the impact of a hypnotic relaxation intervention compared to progressive muscle relaxation on body image distress.

   Hypothesis 1: Women randomized to the hypnotic relaxation will have significantly more improvement in body image distress as measured by the Impact of Treatment Scale than women randomized to receive progressive muscle relaxation at 6 weeks.
2. Evaluate the impact of a hypnotic relaxation intervention compared to progressive relaxation on sexual self-image, sexual health, and mood.

   Hypothesis 2: Women randomized to hypnotic relaxation will show significantly more improvement on the Sexual Self-Schema Scale, the Patient Reported Outcomes Measurement Information System (PROMIS) sexual health scale and the Positive-Negative Affect Scale (PANAS) than women receiving progressive relaxation at 6 weeks.
3. Evaluate the side effects of hypnotic and progressive muscle relaxation. Hypothesis 3a: Hypnotic relaxation will not be associated with significantly more negative side effects than progressive muscle relaxation.

   Hypothesis 3b: Neither hypnotic nor progressive muscle relaxation will be associated with negative side effects.
4. Explore the physiologic effects of hypnotic relaxation compared to progressive muscle relaxation by evaluating cortisol slopes and comparing am/pm cortisol values.

Hypothesis 4a: Women receiving hypnotic relaxation will have a steeper cortisol slope, higher am and lower pm cortisol concentrations at the end of 6 weeks compared with women receiving progressive muscle relaxation.

Women will be referred from providers in the Breast and Gynecology Clinics of the University of Michigan Cancer Center as well as the Symptom Management, Sexual Health and Psycho-Oncology clinics. The study coordinator will provide education about the trial and a consent form will be provided for review. If a woman decides to participate, she will sign the consent form. Sessions will be held at Dr. Barton's behavioral research office located on Washtenaw Avenue in Ann Arbor, where there is privacy, a recliner, a relaxing environment, and convenient parking.

Both intervention arms will involve three sessions that will occur at 2 week intervals. Each visit will last about 40 minutes to an hour.

A Mind-body Intervention to Improve Body and/or Self Image

A Mind-body Intervention to Improve Body and/or Self Image: a Phase II Randomized Trial

Small pilot study for feasibility and effect size. Data would not be helpful to others; too small for secondary analysis.

Using the numeric analog scale of 0 (none) to 10 (as bad as it can be), women will be asked to answer a number of questions about potential negative experiences related to the intervention.

This is a provider grading scale used in National Cancer Institute Clinical Trials. The adverse events that will be assessed and graded in this trial based on relevancy are the psychiatric disorders: agitation, anxiety, insomnia, restlessness personality change and psychoses.

A daily log that was developed by the investigator to measure days of practice.

A daily log that was developed by the investigator to measure minutes of practice.

This scale is a measure of body change stress and was developed by investigators at The Ohio State University. It was developed and tested specifically in women with breast cancer and then edited a little and tested in women with gynecologic cancer. It has demonstrated good reliability and validity in both samples, with Cronbach alphas over .90, and was able to discriminate between women with lower and higher satisfaction with their sexual life.

This scale was developed by investigators from The Ohio State University (OSU) in female undergraduates at OSU and was later tested in a group of community women and subsequently in women with gynecologic cancer and breast cancer. It is a measure of 26 trait adjectives that are self-rated from 0 (not descriptive of me) to 6 (very much descriptive of me). Three dimensions have been demonstrated: passionate/romantic; open/direct and embarrassed/conservative. Cronbach's alpha has been demonstrated to be .76.

The PROMIS initiative is a large effort supported by the National Institute of Health and was created in such a way that investigators can use items that are relevant to the population and research question while maintaining validity. Most of the measures were developed in the cancer population. The sexual function and satisfaction measure is one tool that has good content, face, discriminant, and convergent validity, and is, therefore, ready to be incorporated into clinical trials. It demonstrates good convergent validity with the Female Sexual Function Index (FSFI), which is considered the gold standard measure in sexual function, but PROMIS is shorter and easier to score. The global satisfaction domain with 7 items (correlation of 0.76 with the FSFI satisfaction subscale) and interest domain with 4 items (correlation of 0.84 with the FSFI desire subscale) with two questions about interfering factors (hot flashes and fatigue) for a total of 13 items are being used.

The PANAS was developed as a brief measure to evaluate self-reported mood, focusing on positive and negative affect. Conceptually, positive affect represents a state of high engagement and enthusiasm whereas negative affect represents a state of distress and lack of engagement. It contains 20 items, 10 measuring positive affect and 10 measuring negative affect. It has high internal consistency (.88 PA and .85 NA) when participants answer about their feelings in the past few days. The scale was developed in an undergraduate student population, but since development, it has been used in a wide range of populations including women with breast cancer.

The Subject Global Impression of Change is a 7-point item in which the participant rates the change in the overall status 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. This tool measures perception of benefit from the study intervention by the participant.

Breast Cancer Research Foundation

University of Michigan

Professor

Symptoms and General Pathology

Hot Flashes

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.

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.

Self-Administered Hypnosis

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.

Self-Administered White Noise Hypnosis

Gary Elkins, Ph.D.

Debra Barton, RN,PhD,FAAN

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.

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.

Participants will be randomized and either be assigned to the self-hypnosis group or a self-administered white noise hypnosis group.

A Mind-Body Intervention for Hot Flash Management

Self-Administered Hypnosis Treatment for the Management of Hot Flashes in Women: A Randomized Clinical Trial

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Mind-body Intervention to Improve Body and/or Self Image	NCT02531997	Breast Cancer Ovarian Cancer Uterine Cancer Cervical Cancer	Hypnotic Relaxa... Progressive Mus...	21 Years -	University of Michigan
A Mind-Body Intervention for Hot Flash Management	NCT03572153	Hot Flashes Postmenopausal ... Breast Cancer	Self-Administer... Self-Administer...	18 Years -	Baylor University

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