Nurse-Led Program for Gynecologic Cancers

Overseen By Corina P Hernandez, MSN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Severe psychiatric, Neurological, Sexual violence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a nurse-led program can improve sexual health care for individuals with gynecological cancer. The program aims to boost screening and referral rates for sexual issues and enhance the treatment of sexual dysfunction. Participants will work with advanced practice providers, complete a sexual health survey, and allow researchers to review their medical records. It suits those who have had gynecologic cancer, completed treatment within the past year, and are experiencing sexual health concerns. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies that could enhance sexual health support for future patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that patients may be on maintenance therapy, which suggests you might be able to continue some treatments.

What prior data suggests that this nurse-led program is safe for individuals with gynecological cancer?

Research shows that programs led by nurses are generally safe and well-received. Studies have found that these nurse-led programs can effectively improve sexual health care without harming participants. They focus on education and support, which usually carry a low risk of side effects.

A review of several studies found that nurse-led sexual health programs increased awareness and treatment for sexual issues in patients with gynecological cancer. The goal is to improve quality of life, and no reports of serious negative effects have emerged from these programs.

Since this trial does not test a new drug or medical procedure, but rather an educational and supportive program, safety concerns are minimal. Participants can expect a supportive environment aimed at enhancing their sexual health and overall well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nurse Led Sexual Health Clinical Program Intervention because it addresses the often-overlooked aspect of sexual health for gynecologic cancer survivors. Unlike traditional treatment options that focus primarily on cancer eradication, this program offers a comprehensive approach to sexual wellness, including personalized assessments and tailored plans. By incorporating pelvic exams, sexual health education, and specialty referrals, it provides a holistic support system that can significantly enhance the quality of life for these patients. This novel approach highlights the importance of integrating sexual health into cancer aftercare, promising a more complete recovery experience.

What evidence suggests that this nurse-led program is effective for improving sexual health care in individuals with gynecological cancer?

Research has shown that programs led by nurses can improve sexual health for women who have survived gynecological cancer. In this trial, participants will receive a Nurse-Led Sexual Health Clinical Program Intervention. This includes a pelvic exam, focused sexual health assessment, sexual health plan of care, sexual health education, and specialty referrals as needed. One study found that women in similar programs reported better sexual function and felt less upset, indicating that a nurse's guidance can address their concerns more effectively. Another study found that these programs helped women return to sexual activity after treatments like radiotherapy. Overall, strong evidence supports that nurse-led programs can enhance sexual health and improve the quality of life for women affected by gynecological cancers. ^{1 6 7 8 9}

Who Is on the Research Team?

Leah Spiro, DNP

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with gynecological cancer experiencing sexual dysfunction. Participants will engage in a nurse-led program, complete surveys on sexual function, and permit medical record reviews by the research team.

Inclusion Criteria

I am between 30 and 65 years old.

I have a history of cancer in my reproductive organs.

I finished my cancer treatment within the last year.

Exclusion Criteria

Patients with a history of sexual violence or sexual assault

Any records flagged 'break the glass' or 'research opt-out'

Patients with severe psychiatric disorders that would impair consent or participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Nurse-Led Intervention

Participants receive a nurse-led intervention including a pelvic exam, focused sexual health assessment, sexual health plan of care, sexual health education, and specialty referrals as needed

12 weeks

Follow-up visits with advanced practice provider

Follow-up

Participants are monitored for improvement in sexual dysfunction using the Female Sexual Function Index

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nurse Led Sexual Health Clinical Program Intervention

Trial Overview The study tests a nurse-led sexual health clinical program aimed at improving treatment for sexual dysfunction in gynecological cancer patients by increasing screenings and referrals.

How Is the Trial Designed?

Group I: Nurse Led Sexual Health Intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10867355/

Gynecological cancer survivors' experiences with sexual ... A mixed method study showed that a nurse‐led intervention helped GC survivors resume sexual activity after radiotherapy.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07144566

Improving Sexual Health in Gynecological Cancer Patients 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 ...

3. nature.com nature.com/articles/s41416-024-02775-8

Efficacy of a nurse-led sexual rehabilitation intervention for ... Results indicated that such interventions can lead to improved sexual functioning, reduced sexual distress, and when the partner was actively ...

4. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)04345-7/fulltext

Cost-effectiveness of a nurse-led sexual rehabilitation ... A nurse-led sexual rehabilitation intervention for women treated with radiotherapy for gynaecological cancer in a randomized trial

5. journals.lww.com journals.lww.com/cancernursingonline/fulltext/9900/self_reported_sexual_health_related_outcomes_in.393.aspx

Self-reported Sexual Health-Related Outcomes in... The aim of this study was to investigate changes in sexual health–related outcomes among gynecological cancer survivors comparing 2 different follow-up models.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301625062030

Sexual Health and Quality of Life Outcomes in Recent ... This review examines the following 4 contemporary trials that address sexual health and PROs in women with gynecologic cancers: 1. A nurse-led sexual ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11330549/

Effect of Sexual Counseling Training in Gynecological ... The results showed that sexual counseling training in gynecological cancer according to the PLISSIT Model was effective in the formation of awareness and ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/66/NCT07144566/Prot_000.pdf

Implementation of a Nurse-Led Program to Decrease Sexual ... • Chart review to count the number of referrals and treatments for sexual dysfunction before and after the nurse led sexual health clinical program intervention.

9. mdpi.com mdpi.com/1718-7729/32/8/457

A Narrative Review of the Roles of Nursing in Addressing ... Sexual dysfunction affects an estimated 50–70% of cancer survivors but remains underrecognized and undertreated, impacting quality of life ...