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

NCT06307470 | Completed

• 1 other identifier: 276879
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

breast cancer; young women; cancer survivorship; sexual functioning; body image; premature menopause

Outcome Measures

Primary Outcomes (3)

• Vulvovaginal Symptoms Questionnaire (VSQ)

  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 16, Week 22

• Body Image Scale

  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 16, Week 22

• Female Sexual Functioning Index

  A 19-item survey measuring female sexual functioning. Scores range from 2 - 36 with the higher score representing greater sexual function.

  Week 1, Week 16, Week 22

Study Arms (2)

EMBRACE Group

EXPERIMENTAL

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.

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

Delayed EMBRACE Group

ACTIVE COMPARATOR

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.

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

Interventions

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

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.

Delayed EMBRACE Group; EMBRACE Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Participant eligibility is based on gender at birth.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead
• Intimate Pathways Center for Sexual Health: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (12)

• Juraskova I, Jarvis S, Mok K, Peate M, Meiser B, Cheah BC, Mireskandari S, Friedlander M. The acceptability, feasibility, and efficacy (phase I/II study) of the OVERcome (Olive Oil, Vaginal Exercise, and MoisturizeR) intervention to improve dyspareunia and alleviate sexual problems in women with breast cancer. J Sex Med. 2013 Oct;10(10):2549-58. doi: 10.1111/jsm.12156. Epub 2013 May 1.

  PMID: 23635341 BACKGROUND

• Wettergren L, Eriksson LE, Bergstrom C, Hedman C, Ahlgren J, Smedby KE, Hellman K, Henriksson R, Lampic C. Prevalence and risk factors for sexual dysfunction in young women following a cancer diagnosis - a population-based study. Acta Oncol. 2022 Oct;61(10):1165-1172. doi: 10.1080/0284186X.2022.2112283. Epub 2022 Sep 29.

  PMID: 36176069 BACKGROUND

• Marsh S, Borges VF, Coons HL, Afghahi A. Sexual health after a breast cancer diagnosis in young women: clinical implications for patients and providers. Breast Cancer Res Treat. 2020 Dec;184(3):655-663. doi: 10.1007/s10549-020-05880-3. Epub 2020 Sep 23.

  PMID: 32968951 BACKGROUND

• Rash JK, Seaborne LA, Peterson M, Kushner DM, Sobecki JN. Patient reported improvement in sexual health outcomes following care in a sexual health clinic for women with cancer. Support Care Cancer. 2023 Feb 16;31(3):171. doi: 10.1007/s00520-023-07635-4.

  PMID: 36795172 BACKGROUND

• Esplen MJ, Wong J, Warner E, Toner B. Restoring Body Image After Cancer (ReBIC): Results of a Randomized Controlled Trial. J Clin Oncol. 2018 Mar 10;36(8):749-756. doi: 10.1200/JCO.2017.74.8244. Epub 2018 Jan 22.

  PMID: 29356610 BACKGROUND

• Mifsud A, Pehlivan MJ, Fam P, O'Grady M, van Steensel A, Elder E, Gilchrist J, Sherman KA. Feasibility and pilot study of a brief self-compassion intervention addressing body image distress in breast cancer survivors. Health Psychol Behav Med. 2021 May 21;9(1):498-526. doi: 10.1080/21642850.2021.1929236.

  PMID: 34104572 BACKGROUND

• Jun EY, Kim S, Chang SB, Oh K, Kang HS, Kang SS. The effect of a sexual life reframing program on marital intimacy, body image, and sexual function among breast cancer survivors. Cancer Nurs. 2011 Mar-Apr;34(2):142-9. doi: 10.1097/NCC.0b013e3181f1ab7a.

  PMID: 20885305 BACKGROUND

• Panjari M, Bell RJ, Davis SR. Sexual function after breast cancer. J Sex Med. 2011 Jan;8(1):294-302. doi: 10.1111/j.1743-6109.2010.02034.x. Epub 2010 Sep 23.

  PMID: 21199377 BACKGROUND

• Rosenberg SM, Vaz-Luis I, Gong J, Rajagopal PS, Ruddy KJ, Tamimi RM, Schapira L, Come S, Borges V, de Moor JS, Partridge AH. Employment trends in young women following a breast cancer diagnosis. Breast Cancer Res Treat. 2019 Aug;177(1):207-214. doi: 10.1007/s10549-019-05293-x. Epub 2019 May 30.

  PMID: 31147983 BACKGROUND

• Ruddy KJ, Greaney ML, Sprunck-Harrild K, Meyer ME, Emmons KM, Partridge AH. A qualitative exploration of supports and unmet needs of diverse young women with breast cancer. J Community Support Oncol. 2015 Sep;13(9):323-9. doi: 10.12788/jcso.0169.

  PMID: 26859752 BACKGROUND

• Vegunta S, Kuhle CL, Vencill JA, Lucas PH, Mussallem DM. Sexual Health after a Breast Cancer Diagnosis: Addressing a Forgotten Aspect of Survivorship. J Clin Med. 2022 Nov 14;11(22):6723. doi: 10.3390/jcm11226723.

  PMID: 36431200 BACKGROUND

• Gorman JR, Drizin JH, Smith E, Flores-Sanchez Y, Harvey SM. Patient-Centered Communication to Address Young Adult Breast Cancer Survivors' Reproductive and Sexual Health Concerns. Health Commun. 2021 Nov;36(13):1743-1758. doi: 10.1080/10410236.2020.1794550. Epub 2020 Jul 23.

  PMID: 32703034 BACKGROUND

MeSH Terms

Conditions

Menopause, Premature; Sexual Dysfunction, Physiological; Breast Neoplasms

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pearman D Parker, PhD, MPH, RN

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: October 15, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)