Nurse-led Mind-body Intervention on Sexual Health for Breast Cancer Survivors

March 18, 2024 updated by: University of Arkansas

Impact of a Nurse-led Mind-body Intervention on Sexual Health for Young Women

The goal of this clinical trial is to test the efficacy of a nurse-led psychoeducational sexual health intervention for young women breast cancer survivors. The main questions it aims to answer are:

  1. What is the feasibility of this intervention in an online, private setting?
  2. What is the effect of this intervention on reducing menopausal symptoms, improving sexual functioning, and enhancing body image?

Participants will participate in a nurse-led psychoeducational intervention for 8 sessions lasting approximately an hour each over the course of 8 - 10 weeks. Each participant will complete survey items at the beginning, end, and six-weeks after the last session. Participants will be compensated up to $150 in gift cards as a thank-you for their time.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Pearman D Parker, PhD, MPH, RN
  • Phone Number: 501-661-7901
  • Email: pparker@uams.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with breast cancer (stages I - III) between ages 18 - 50
  • Completed active treatment (chemotherapy and/or radiation) within the last five years
  • Can read/speak English
  • Access to talk in quiet, safe environment for privacy
  • On hormonal therapies (aromatase inhibitors, tamoxifen)
  • Currently partnered (i.e., in a relationship)

Exclusion Criteria:

  • Currently undergoing active treatment (chemotherapy and/or radiation)
  • More than five years have passed since completing active treatment (chemotherapy and/or radiation)
  • History of advanced breast cancer (stage IV) or a breast cancer recurrence
  • Women without access to the internet
  • Cannot read/speak in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMBRACE Group
Immediately following consent, participants randomized to the EMBRACE Group will begin with the EMBRACE intervention. Participants will meet with a registered nurse certified in sexuality and sex education once weekly for 8 - 10 weeks depending on scheduling. Each of the 8 sessions will last between 60 - 90 minutes. Participants will complete baseline measures, immediately following the intervention, and six weeks after the last session. Participants will be compensated for their time with a total up to $150.
Behavioral: EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience)
The intervention will be led by a registered nurse who holds certifications in sexuality counseling and sex education. The therapeutic, online environment will serve as a confidential, private space without judgement to encourage discussion to model safe sexuality communication for breast cancer survivors. The curriculum will include: i) psychoeducation: sexual body, mind-body connection, and sexual relationships; ii) physical-body education: physical response, safety, and navigating physical changes in survivorship; iii) solution-focused tools: tailored vaginal rehydration, lubrication, education; and iv) communication: internal, partnered, and patient-provider communication skills.
Active Comparator: Delayed EMBRACE Group
After consenting, participants randomized to the Delayed EMBRACE Group will begin with the EMBRACE intervention 8 weeks after enrollment. Participants will meet with a registered nurse certified in sexuality and sex education once weekly for 8 - 10 weeks depending on scheduling. Each of the 8 sessions will last between 60 - 90 minutes. Participants will complete baseline measures, immediately following the intervention, and six weeks after the last session. Participants will be compensated for their time with a total up to $150.
Behavioral: EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience)
The intervention will be led by a registered nurse who holds certifications in sexuality counseling and sex education. The therapeutic, online environment will serve as a confidential, private space without judgement to encourage discussion to model safe sexuality communication for breast cancer survivors. The curriculum will include: i) psychoeducation: sexual body, mind-body connection, and sexual relationships; ii) physical-body education: physical response, safety, and navigating physical changes in survivorship; iii) solution-focused tools: tailored vaginal rehydration, lubrication, education; and iv) communication: internal, partnered, and patient-provider communication skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vulvovaginal Symptoms Questionnaire (VSQ)
Time Frame: Week 1, Week 8, Week 14
A 21-item survey designed to measure vaginal symptoms, emotions, life impact due to vulvovaginal symptoms, and sexual impact of vulvovaginal symptoms. The scores range from 0 - 20 with the higher score meaning greater impact from vulvovaginal symptoms.
Week 1, Week 8, Week 14
Body Image Scale
Time Frame: Week 1, Week 8, Week 14
A 10-item survey designed to measure body image changes after cancer treatment. Scores range from 0 - 30 with the higher scores representing more body image disturbances related to cancer treatment.
Week 1, Week 8, Week 14
Female Sexual Functioning Index
Time Frame: Week 1, Week 8, Week 14
A 19-item survey measuring female sexual functioning. Scores range from 2 - 36 with the higher score representing greater sexual function.
Week 1, Week 8, Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Collaborators

Intimate Pathways Center for Sexual Health

Investigators

  • Principal Investigator: Pearman D Parker, PhD, MPH, RN, University of Arkansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 276879

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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