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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531997
• Other study ID #: HUM00100709
• Status: Completed
• Phase: N/A
• First received: August 19, 2015
• Last updated: December 10, 2017
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Cervical Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Uterine Cancer
• Uterine Cervical Neoplasms
• Uterine Neoplasms

Intervention

Behavioral:
• Hypnotic Relaxation Therapy
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 Relaxation
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.

Locations

Country	Name	City	State
United States	University of Michigan School of Nursing	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Breast Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-Report Side Effect Questionnaire	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.	Weekly through end of study about 6 weeks
Other	Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	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.	Weekly for 6 weeks
Other	Practice Log days	A daily log that was developed by the investigator to measure days of practice.	Daily through end of study about 6 weeks
Other	Practice Log minutes	A daily log that was developed by the investigator to measure minutes of practice.	Daily through end of study about 6 weeks
Primary	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.	Change from baseline at 6 weeks
Secondary	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.	Change from baseline at 6 weeks
Secondary	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.	Change from baseline at 6 weeks
Secondary	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.	Change from baseline at 6 weeks
Secondary	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.	End of study about 6 weeks