Gynaecologic CancerNCT07144566
Improving Sexual Health in Gynecological Cancer Patients
A study testing Nurse Led Sexual Health Clinical Program Intervention in people with Gynaecologic Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Gynaecologic Cancer
- What is being tested?
- Nurse Led Sexual Health Clinical Program Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 900048
Corina P Hernandez, MSN, 310-423-6074, corina.hernandez@cshs.org
Leah Spiro, DNP
About this study
Official title: Implementation of a Nurse-Led Clinical Program to Decrease Sexual Dysfunction Among Gynecological Cancer Patient
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.
- Conditions
- Gynaecologic Cancer
- Being tested
- Nurse Led Sexual Health Clinical Program Intervention
- Keywords
- Survivorship, Sexual Health, Sexual Dysfunction, Gynecologic Cancer
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Led Sexual Health Clinical Program InterventionOther
Also called Sexual health education, Sexual health treatment plan, Sexual Health Referrals, Sexual health focused pelvic exam
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Nurse Led Sexual Health Clinical Program Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start2 Sep 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gynaecologic CancerStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leah Spiro, Cedars-Sinai Medical Center
- Investigators
- Leah Spiro, DNP, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144566
- Sponsor's protocol ID
- 00004279
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 36800552Sitlinger 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 30213412Hungr 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 31167551Wang 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 32820237Seaborne 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 33552660Chow 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 37690804Sousa 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 36231221Kaufman 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 at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Nurse-Led Clinical Program to Decrease Sexual Dysfunction Among Gynecological Cancer Patient
- ClinicalTrials.gov ID
- NCT07144566
- Acronym / sponsor ID
- 00004279
- Conditions
- Gynaecologic Cancer
- Keywords
- Survivorship, Sexual Health, Sexual Dysfunction, Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 2 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nurse Led Sexual Health Intervention | Experimental | Other: Nurse Led Sexual Health Clinical Program InterventionGynecologic 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse Led Sexual Health Clinical Program InterventionAlso: Sexual health education, Sexual health treatment plan, Sexual Health Referrals, Sexual health focused pelvic examIn 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 | Nurse Led Sexual Health Intervention |
Primary outcome
Effectiveness of the nurse led clinical sexual health dysfunction program
Time frame: 12 weeks
Assess improvement in sexual dysfunction in gynecologic cancer survivors via the Female Sexual Function Index (FSFI).
Effectiveness of the nurse led clinical sexual health dysfunction program
Time frame: 12 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Results publication: PubMed 36800552Birch 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.
- Results publication: PubMed 30213412Sitlinger 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.
- Results publication: PubMed 31167551Hungr 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.
- Results publication: PubMed 32820237Wang 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.
- Results publication: PubMed 33552660Seaborne 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.
- Results publication: PubMed 37690804Chow 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.
- Results publication: PubMed 36231221Sousa 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.
- Results publication: PubMed 39269314Kaufman 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.
- Individual participant dataSharing planned: No
Related trials for Gynaecologic Cancer
RecruitingPhase 2
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
Breast Cancer, Corpus Uteri Cancer
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
Enrolling by invitation
Peer Ambassador in Gyn Onc Trials
Ovarian Cancer
Active, not recruitingPhase 2
Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer
Ovarian Clear Cell Carcinoma, Gynecologic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leah Spiro, DNP principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Led Sexual Health Clinical Program Intervention in people with Gynaecologic Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corina P Hernandez, MSN (310-423-6074, corina.hernandez@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the nurse led clinical sexual health dysfunction program (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07144566, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.