Clinical trial NCT02531997: A Mind-body Intervention to Improve Body and/or Self Image
Official title: A Mind-body Intervention to Improve Body and/or Self Image: a Phase II Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
hypnotic relaxation therapy
hypnosis
progressive muscle relaxation
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2015-08-25
Enrollment: 97
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Impact of Treatment Scale
timeFrame: Change from baseline at 6 weeks
Secondary outcomes:
measure: Sexual Self-Schema Scale for Women
timeFrame: Change from baseline at 6 weeks
measure: PROMIS Sexual Health Measure
timeFrame: Change from baseline at 6 weeks
measure: Positive/Negative Affect Scale (PANAS)
timeFrame: Change from baseline at 6 weeks
measure: Global Impression of Change, effort and satisfaction
timeFrame: End of study about 6 weeks
Other outcomes:
measure: Self-Report Side Effect Questionnaire
timeFrame: Weekly through end of study about 6 weeks
measure: Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
timeFrame: Weekly for 6 weeks
measure: Practice Log days
timeFrame: Daily through end of study about 6 weeks
measure: Practice Log minutes
timeFrame: Daily through end of study about 6 weeks
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Nursing
state: Michigan
Study officials:
affiliation: University of Michigan School of Nursing
name: Debra Barton, RN, PhD, FAAN
role: PRINCIPAL_INVESTIGATOR
References: