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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

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