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

Sexual Dysfunction Clinical Trial

Official title:

Impact of a Nurse-led Mind-body Intervention on Sexual Health for Young Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06307470
• Other study ID #: 276879
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2024
• Est. completion date: May 30, 2025

Study information

• Verified date: March 2024
• Source: University of Arkansas
• Contact: Pearman D Parker, PhD, MPH, RN
• Phone: 501-661-7901
• Email: pparker[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 8 - 10 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Image
• Breast Neoplasms
• Cancer, Breast
• Menopause, Premature
• Primary Ovarian Insufficiency
• Sexual Dysfunction
• Women's Health: Neoplasm of Breast

Intervention

Behavioral:
• EMBRACE (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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	Intimate Pathways Center for Sexual Health

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 8, Week 14
Primary	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 8, Week 14
Primary	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 8, Week 14