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

University of Arkansas

Status: Active, not recruiting

Conditions: Menopause, Premature; Cancer, Breast; Body Image; Sexual Dysfunction; Women's Health: Neoplasm of Breast

Treatments: Behavioral: EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience)

Study type: Interventional

Funder types: Other

Identifiers

NCT06307470

276879

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

43 participants in 2 patient groups

EMBRACE Group

Experimental group

Description:

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 for 8 sessions every two weeks depending on scheduling. Each of the 8 sessions will last between 60 - 90 minutes. By session 2, participants will receive vaginal rehydration (Hyalo-Gyn suppositories), vaginal dilation (CalExotics Dr. Berman Dilator), and vaginal lubrication (Good Clean Love BioNude). These products will be mailed to participants at no cost to the participants. 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.

Treatment:

Behavioral: EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience)

Delayed EMBRACE Group

Active Comparator group

Description:

After consenting, participants randomized to the Delayed EMBRACE Group will begin with the EMBRACE intervention 16 weeks after enrollment. Participants will meet with a registered nurse certified in sexuality and sex education for 8 sessions every two weeks depending on scheduling. Each of the 8 sessions will last between 60 - 90 minutes. By session 2, participants will receive vaginal rehydration (Hyalo-Gyn suppositories), vaginal dilation (CalExotics Dr. Berman Dilator), and vaginal lubrication (Good Clean Love BioNude). These products will be mailed to participants at no cost to the participants. 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.

Treatment:

Behavioral: EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience)