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Not yet recruiting NCT07144566

Improving Sexual Health in Gynecological Cancer Patients

No phase Interventional Gynaecologic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nurse Led Sexual Health Clinical Program Intervention.
Who it may be relevant to
Registry conditions: Gynaecologic Cancer. Basic parameters: 30 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Implementation of a Nurse-Led Clinical Program to Decrease Sexual Dysfunction Among Gynecological Cancer Patient

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • Effectiveness of the nurse led clinical sexual health dysfunction program [Time frame: 12 weeks]
  • Effectiveness of the nurse led clinical sexual health dysfunction program [Time frame: 12 weeks]

Eligibility criteria

Inclusion:

  • 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:

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Cedars Sinai Medical Center — Los Angeles

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 39269314

Identifiers

NCT: NCT07144566 · 00004279

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗