Body Image, Cancer, Breast, Menopause, Premature, Sexual Dysfunction, Women's Health: Neoplasm of Breast
Conditions
Keywords
breast cancer, young women, cancer survivorship, sexual functioning, body image, premature menopause
Brief 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.
Interventions
BEHAVIORALEMBRACE (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. The solution-focused tools will include vaginal rehydration and dilation products with vaginal lubrication. Tools will be distributed via mail by Session 2.
Sponsors
Intimate Pathways Center for Sexual Health
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vulvovaginal Symptoms Questionnaire (VSQ) | Week 1, Week 16, Week 22 | 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. |
| Body Image Scale | Week 1, Week 16, Week 22 | 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. |
| Female Sexual Functioning Index | Week 1, Week 16, Week 22 | A 19-item survey measuring female sexual functioning. Scores range from 2 - 36 with the higher score representing greater sexual function. |
Countries
United States
Outcome results
None listed