Improving Sexual Health in Gynecological Cancer Patients
Implementation of a Nurse-Led Clinical Program to Decrease Sexual Dysfunction Among Gynecological Cancer Patient
1 other identifier
interventional
35
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2025
CompletedFirst Posted
Study publicly available on registry
August 27, 2025
CompletedStudy Start
First participant enrolled
September 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedAugust 27, 2025
August 1, 2025
4 months
August 17, 2025
August 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
Nurse Led Sexual Health Intervention
EXPERIMENTALGynecologic 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients with a gynecologic cancer history
- Patients ages 30-65 years old
- Patients must have completed cancer treatment within the past 12 months
- Patients may be on maintenance therapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cedars Sinai Medical Center
Los Angeles, California, 900048, United States
Related Publications (8)
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.
PMID: 36800552RESULTSitlinger 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.
PMID: 30213412RESULTHungr 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.
PMID: 31167551RESULTWang 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.
PMID: 32820237RESULTSeaborne 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.
PMID: 33552660RESULTChow 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.
PMID: 37690804RESULTSousa 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.
PMID: 36231221RESULTKaufman 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.
PMID: 39269314RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leah Spiro, DNP
Cedars-Sinai Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Research Nurse Scientist, Nurse Practitioner, Brawerman Nursing Institute, Principal Investigator
Study Record Dates
First Submitted
August 17, 2025
First Posted
August 27, 2025
Study Start
September 2, 2025
Primary Completion
December 31, 2025
Study Completion
April 30, 2026
Last Updated
August 27, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share