Clinical trial · Interventional
Nurse-led Mind-body Intervention on Sexual Health for Breast Cancer Survivors
Impact of a Nurse-led Mind-body Intervention on Sexual Health for Young Women
NCT06307470CI-TRIAL-00099706completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Body Image | — | UNRESOLVED | — |
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Menopause, Premature | — | UNRESOLVED | — |
| Sexual Dysfunction | — | UNRESOLVED | — |
| Women's Health: Neoplasm of Breast | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EMBRACE 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.
- interventionNames
- Behavioral: EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience)
- type
- ACTIVE_COMPARATOR
- label
- Delayed EMBRACE 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (12)
- BACKGROUNDJuraskova 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
- BACKGROUNDWettergren 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
- BACKGROUNDMarsh 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
- BACKGROUNDRash 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
- BACKGROUNDEsplen 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
- BACKGROUNDMifsud 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