Improving Sexual Health in Gynecological Cancer Patients
NCT ID: NCT07144566
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
35 participants
INTERVENTIONAL
2025-09-02
2026-04-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Nurse Led Sexual Health Intervention
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.
Nurse Led Sexual Health Clinical Program Intervention
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.
Interventions
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Nurse Led Sexual Health Clinical Program Intervention
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients ages 30-65 years old
* Patients must have completed cancer treatment within the past 12 months
* Patients may be on maintenance therapy
Exclusion:
* Any records flagged "break the glass" or "research opt-out."
* Patients with severe psychiatric disorders that would impair consent or participation
* Patients with neurological disorders affecting sexual function
* Patients with a history of sexual violence or sexual assault
30 Years
65 Years
FEMALE
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Leah Spiro
Clinical Research Nurse Scientist, Nurse Practitioner, Brawerman Nursing Institute, Principal Investigator
Principal Investigators
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Leah Spiro, DNP
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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00004279
Identifier Type: -
Identifier Source: org_study_id
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