NCT02531997

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

2.3 years

First QC Date

August 19, 2015

Last Update Submit

December 10, 2017

Conditions

Breast CancerOvarian CancerUterine CancerCervical Cancer

Keywords

self-imagesexual healthbreast cancergynecologic cancerovarian cancercervical canceruterine cancermind bodyhypnotic relaxation therapyhypnosisprogressive muscle relaxation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Sexual Self-Schema Scale for Women

    Change from baseline at 6 weeks

  • PROMIS Sexual Health Measure

    Change from baseline at 6 weeks

  • Positive/Negative Affect Scale (PANAS)

    Change from baseline at 6 weeks

  • Global Impression of Change, effort and satisfaction

    End of study about 6 weeks

Other Outcomes (4)

  • Self-Report Side Effect Questionnaire

    Weekly through end of study about 6 weeks

  • Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

    Weekly for 6 weeks

  • Practice Log days

    Daily through end of study about 6 weeks

  • +1 more other outcomes

Study Arms (2)

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.

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.

Behavioral: Progressive Muscle Relaxation

Interventions

Hypnotic Relaxation TherapyBEHAVIORAL

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
Progressive Muscle RelaxationBEHAVIORAL

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 (PMR)

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan School of Nursing

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • 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.

    PMID: 37114974DERIVED

MeSH Terms

Conditions

Breast NeoplasmsOvarian NeoplasmsUterine NeoplasmsUterine Cervical Neoplasms

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine DiseasesUterine Cervical Diseases

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Debra Barton, RN, PhD, FAAN

    University of Michigan School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 19, 2015

First Posted

August 25, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 12, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

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

Locations

US(1)