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

NCT02531997CompletedNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

University of Michigan

Enrollment

Start Date

2015-08-01

Completion Date

2017-12-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Hypnotic Relaxation TherapyProgressive Muscle Relaxation

Conditions

Breast CancerOvarian CancerUterine CancerCervical Cancer

Eligibility

Age Range

21 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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.

Time frame: Change from baseline at 6 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: End of study about 6 weeks

Locations

University of Michigan School of Nursing, Ann Arbor, United States