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The goal of this clinical trial is to test whether a nurse-led program can improve screening and referral rates for sexual dysfunction and improve sexual health care in individuals with gynecological cancer. The main questions it aims to answer are:
Does participation in a nurse-led program improve the treatment of sexual dysfunction in individuals with gynecological cancer?
Does the program increase the frequency of screenings and referrals for sexual dysfunction?
Participants will:
Complete a visit with an advanced practice provider.
Fill out the Female Sexual Function Index survey.
Allow the research team to review medical records.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse Led Sexual Health Intervention | Experimental | Gynecologic Cancer patients ages 30-65yo who completed treatment within 12 months will be offered a sexual health nurse led intervention during follow up visits to include a pelvic exam, focused sexual health assessment, sexual health plan of care, sexual health education, and specialty referrals as needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse Led Sexual Health Clinical Program Intervention | Other | In person visit with Advanced Practice Provider (APP) whom is an Advanced Practice Nurse Practitioner in Oncology. Visit will include a focused pelvic exam, sexual health treatment plan, sexual health education, and referrals that follow the current Sexual Health Survivorship NCCN guidelines. A post visit telephone will be provided by the APP 8 weeks after APP visit for follow up questions and further education if needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of the nurse led clinical sexual health dysfunction program | Assess improvement in sexual dysfunction in gynecologic cancer survivors via the Female Sexual Function Index (FSFI). | 12 weeks |
| Effectiveness of the nurse led clinical sexual health dysfunction program | Assess effectiveness of the nurse led clinical sexual dysfunction program via number of referrals and treatments in the chart before and after the intervention in gynecologic cancer patients. | 12 weeks |
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Inclusion:
Exclusion:
Female born
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Corina P Hernandez, MSN | Contact | 310-423-6074 | corina.hernandez@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Leah Spiro, DNP | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 900048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36800552 | Result | Birch K, Chung S, Zion SR, MacEwan JP, Malecki MJ. Incremental Health Care Costs of Anxiety and Depression Among Medicare Beneficiaries With Cancer. JCO Oncol Pract. 2023 May;19(5):e660-e671. doi: 10.1200/OP.22.00555. Epub 2023 Feb 17. | |
| 30213412 | Result | Sitlinger A, Zafar SY. Health-Related Quality of Life: The Impact on Morbidity and Mortality. Surg Oncol Clin N Am. 2018 Oct;27(4):675-684. doi: 10.1016/j.soc.2018.05.008. Epub 2018 Jul 21. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 11, 2025 | Aug 17, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 13, 2025 | Aug 17, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D012736 | Sex Education |
| ID | Term |
|---|---|
| D044347 | Sexology |
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
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|
| 31167551 | Result | Hungr C, Recklitis CJ, Wright AA, Bober SL. How does a single session group intervention improve sexual function in ovarian cancer survivors? A secondary analysis of effects of self-efficacy, knowledge and emotional distress. Psychol Health Med. 2020 Jan;25(1):110-120. doi: 10.1080/13548506.2019.1626452. Epub 2019 Jun 5. |
| 32820237 | Result | Wang X, Wang N, Zhong L, Wang S, Zheng Y, Yang B, Zhang J, Lin Y, Wang Z. Prognostic value of depression and anxiety on breast cancer recurrence and mortality: a systematic review and meta-analysis of 282,203 patients. Mol Psychiatry. 2020 Dec;25(12):3186-3197. doi: 10.1038/s41380-020-00865-6. Epub 2020 Aug 20. |
| 33552660 | Result | Seaborne LA, Peterson M, Kushner DM, Sobecki J, Rash JK. Development, Implementation, and Patient Perspectives of the Women's Integrative Sexual Health Program: A Program Designed to Address the Sexual Side Effects of Cancer Treatment. J Adv Pract Oncol. 2021 Jan-Feb;12(1):32-38. doi: 10.6004/jadpro.2021.12.1.3. Epub 2021 Jan 1. |
| 37690804 | Result | Chow KM, Chan Yip WHC, Porter-Steele J, Siu KY, Choi KC. Nurse-led sexual rehabilitation to rebuild sexuality and intimacy after treatment for gynaecological cancer: a randomised controlled trial (abridged secondary publication). Hong Kong Med J. 2023 Aug;29 Suppl 4(4):26-30. No abstract available. |
| 36231221 | Result | Sousa Rodrigues Guedes T, Barbosa Otoni Goncalves Guedes M, de Castro Santana R, Costa da Silva JF, Almeida Gomes Dantas A, Ochandorena-Acha M, Terradas-Monllor M, Jerez-Roig J, Bezerra de Souza DL. Sexual Dysfunction in Women with Cancer: A Systematic Review of Longitudinal Studies. Int J Environ Res Public Health. 2022 Sep 21;19(19):11921. doi: 10.3390/ijerph191911921. |
| 39269314 | Result | Kaufman R, Agrawal L, Teplinsky E, Kiel L, Abioye O, Florez N. From diagnosis to survivorship addressing the sexuality of women during cancer. Oncologist. 2024 Dec 6;29(12):1014-1023. doi: 10.1093/oncolo/oyae242. |