Breast CancerNCT02531997
A Mind-body Intervention to Improve Body and/or Self Image
A study testing Hypnotic Relaxation Therapy and Progressive Muscle Relaxation in people with Breast Cancer and Ovarian Cancer, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer, Ovarian Cancer, Uterine Cancer
- What is being tested?
- Hypnotic Relaxation Therapy and Progressive Muscle Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a history of any stage of breast or gynecologic cancer
- reported a change in body/self-image since diagnosis and wish to improve it. Two screening questions will be used: Has body image or self-image changed in an unwanted way since the cancer diagnosis? (Answer must be yes.) Would the potential participant like to be able to do something to improve body image or self-image? (Answer must be yes.)
- Concurrent cancer treatment of any kind is allowed, but the participant can also have completed all treatment
- Performance status of 2 or better
Who cannot join
- Diagnosis of a major depressive episode, an acute anxiety disorder, psychosis, or schizophrenia as listed in the patient's medical history per Diagnostic and Statistical Manual for Mental Health-IV criteria in the chart and/or by self-report
- Past history of sexual abuse.
- Currently on 2 or more antidepressant therapies for mood disturbance of any kind. Past use is allowed, just not current use.
- Currently on 2 or more anti-anxiety therapies. Past use is allowed, just not current use.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Nursing
Ann Arbor, Michigan, 48109
About this study
Official title: A Mind-body Intervention to Improve Body and/or Self Image: a Phase II Randomized Trial
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.
Read the detailed description
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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Breast Cancer, Ovarian Cancer, Uterine Cancer, Cervical Cancer
- Being tested
- Hypnotic Relaxation Therapy, Progressive Muscle Relaxation
- Keywords
- self-image, sexual health, breast cancer, gynecologic cancer, ovarian cancer, cervical cancer, uterine cancer, mind body, hypnotic relaxation therapy, hypnosis, progressive muscle relaxation
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Uterine Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnotic Relaxation TherapyBehavioural
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.
Progressive Muscle RelaxationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypnotic Relaxation Therapy | Active comparator | 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. Receives: Behavioral: Hypnotic Relaxation Therapy |
| Progressive Muscle Relaxation (PMR) | Other | 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. Receives: Behavioral: Progressive Muscle Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Treatment Scale
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.
Measured: Change from baseline at 6 weeks
Secondary outcomes (4)
Sexual Self-Schema Scale for Women
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.
Measured: Change from baseline at 6 weeks
PROMIS Sexual Health Measure
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.
Measured: Change from baseline at 6 weeks
Positive/Negative Affect Scale (PANAS)
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.
Measured: Change from baseline at 6 weeks
Global Impression of Change, effort and satisfaction
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.
Measured: End of study about 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Principal investigator, Debra L. Barton, University of Michigan
- Investigators
- Debra Barton, RN, PhD, FAAN, Principal investigator, University of Michigan School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531997
- Sponsor's protocol ID
- HUM00100709
- Status last verified
- Dec 2017
- First submitted
- 19 Aug 2015
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Small pilot study for feasibility and effect size. Data would not be helpful to others; too small for secondary analysis.
Publications
Arring NM, Lafferty CK, Clark PM, Barton DL. The experience of women in a phase II trial of hypnosis and progressive muscle relaxation for body image: informing future research questions. J Psychosoc Oncol. 2024;42(1):148-158. doi: 10.1080/07347332.2023.2206406. Epub 2023 Apr 28.
PubMed 37114974
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mind-body Intervention to Improve Body and/or Self Image: a Phase II Randomized Trial
- ClinicalTrials.gov ID
- NCT02531997
- Acronym / sponsor ID
- HUM00100709
- Conditions
- Breast Cancer, Ovarian Cancer, Uterine Cancer, Cervical Cancer
- Keywords
- self-image, sexual health, breast cancer, gynecologic cancer, ovarian cancer, cervical cancer, uterine cancer, mind body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnotic Relaxation Therapy | Active comparator | Behavioral: Hypnotic Relaxation TherapyHypnotic 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. |
| Progressive Muscle Relaxation (PMR) | Other | Behavioral: Progressive Muscle RelaxationThe PMR will consist of progressive tensing and relaxing of the muscles from head to toe to a soothing sound of the participant's choosing. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a history of any stage of breast or gynecologic cancer
- reported a change in body/self-image since diagnosis and wish to improve it. Two screening questions will be used: Has body image or self-image changed in an unwanted way since the cancer diagnosis? (Answer must be yes.) Would the potential participant like to be able to do something to improve body image or self-image? (Answer must be yes.)
- Concurrent cancer treatment of any kind is allowed, but the participant can also have completed all treatment
- Performance status of 2 or better
Key exclusion criteria (4 listed)
- Diagnosis of a major depressive episode, an acute anxiety disorder, psychosis, or schizophrenia as listed in the patient's medical history per Diagnostic and Statistical Manual for Mental Health-IV criteria in the chart and/or by self-report
- Past history of sexual abuse.
- Currently on 2 or more antidepressant therapies for mood disturbance of any kind. Past use is allowed, just not current use.
- Currently on 2 or more anti-anxiety therapies. Past use is allowed, just not current use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnotic Relaxation TherapyThere 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. | Behavioural | Hypnotic Relaxation Therapy |
| Progressive Muscle RelaxationWomen 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. | Behavioural | Progressive Muscle Relaxation (PMR) |
Primary outcome
Impact of Treatment Scale
Time frame: Change from baseline at 6 weeks
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.
4 secondary outcomes
Sexual Self-Schema Scale for Women
Time frame: Change from baseline at 6 weeks
PROMIS Sexual Health Measure
Time frame: Change from baseline at 6 weeks
Positive/Negative Affect Scale (PANAS)
Time frame: Change from baseline at 6 weeks
Global Impression of Change, effort and satisfaction
Time frame: End of study about 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Derived from this study: PubMed 37114974Arring NM, Lafferty CK, Clark PM, Barton DL. The experience of women in a phase II trial of hypnosis and progressive muscle relaxation for body image: informing future research questions. J Psychosoc Oncol. 2024;42(1):148-158. doi: 10.1080/07347332.2023.2206406. Epub 2023 Apr 28.
- Individual participant dataSharing planned: No. Small pilot study for feasibility and effect size. Data would not be helpful to others; too small for secondary analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Barton, RN, PhD, FAAN principal investigator
University of Michigan School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotic Relaxation Therapy and Progressive Muscle Relaxation in people with Breast Cancer and Ovarian Cancer, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Treatment Scale (time frame: Change from baseline at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02531997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.