ClinicalTrials.gg
Not yet recruitingNCT07144566Updated Aug 27, 2025

Improving Sexual Health in Gynecological Cancer Patients

An interventional study of Nurse Led Sexual Health Clinical Program Intervention in Gynaecologic Cancer, sponsored by Cedars-Sinai Medical Center. Not yet recruiting at 1 site in United States. Open to female participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-27.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
30 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Gynaecologic Cancer

Keywords

  • Survivorship
  • Sexual Health
  • Sexual Dysfunction
  • Gynecologic Cancer
03

In context

Sexual Dysfunction, Physiological

385 studies on the registry are indexed under Sexual Dysfunction, Physiological; 72 are open to participants now.

This study's planned enrollment of 35 is below the median of 72 across 263 interventional studies indexed under Sexual Dysfunction, Physiological.

Browse Sexual Dysfunction, Physiological studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 456 studies on the registry; 107 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 49 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    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.

    Other: Nurse Led Sexual Health Clinical Program Intervention

Interventions

  • OtherNurse 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.

    Also known as: Sexual health education, Sexual health treatment plan, Sexual Health Referrals, Sexual health focused pelvic exam

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 36800552 ↗
  • 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. PubMed 30213412 ↗
  • 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. PubMed 31167551 ↗
  • 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. PubMed 32820237 ↗
  • 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. PubMed 33552660 ↗
  • 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. PubMed 37690804 ↗
  • 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. PubMed 36231221 ↗
  • 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. PubMed 39269314 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07144566
Responsible party
Leah Spiro (Clinical Research Nurse Scientist, Nurse Practitioner, Brawerman Nursing Institute, Principal Investigator, Cedars-Sinai Medical Center) — Principal investigator
First posted
Aug 27, 2025
Start date
Sep 2, 2025 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Apr 30, 2026 (estimated)
Last update
Aug 27, 2025

Study contacts

Corina P Hernandez, MSN
Contact
corina.hernandez@cshs.org
310-423-6074
Leah Spiro, DNP
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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