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Trial Title:
Nurse-led Mind-body Intervention on Sexual Health for Breast Cancer Survivors
NCT ID:
NCT06307470
Condition:
Women's Health: Neoplasm of Breast
Menopause, Premature
Body Image
Sexual Dysfunction
Cancer, Breast
Conditions: Official terms:
Breast Neoplasms
Menopause, Premature
Primary Ovarian Insufficiency
Conditions: Keywords:
breast cancer
young women
cancer survivorship
sexual functioning
body image
premature menopause
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience)
Description:
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.
The solution-focused tools will include vaginal rehydration and dilation products with
vaginal lubrication. Tools will be distributed via mail by Session 2.
Arm group label:
Delayed EMBRACE Group
Arm group label:
EMBRACE Group
Summary:
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 16 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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Gender description:
Participant eligibility is based on gender at birth.
Minimum age:
18 Years
Maximum age:
50 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Arkansas for Medical Sciences
Address:
City:
Little Rock
Zip:
72205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brooklyn Tody, BS
Email:
EMBRACE@uams.edu
Start date:
October 15, 2024
Completion date:
May 30, 2025
Lead sponsor:
Agency:
University of Arkansas
Agency class:
Other
Collaborator:
Agency:
Intimate Pathways Center for Sexual Health
Agency class:
Other
Source:
University of Arkansas
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06307470