Sexual Health Resources for Gynecologic Cancers

Overseen By Kristen A Sorice

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Fox Chase Cancer Center

Disqualifiers: Non-English, ECOG > 2, cognitive, others

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

Compensation: Varies

Number of Visits: 3

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an educational video and workbook can help gynecologic cancer patients communicate more openly with their doctors about sexual health concerns. Researchers seek to assess whether this program, which includes communication about sexual health, improves sexual function and reduces anxiety and depression compared to receiving only a resource booklet. Participants will receive either a booklet alone or a booklet plus the video and workbook. The trial seeks individuals with gynecologic cancer who are currently receiving treatment or completed treatment within the last 10 years and have ongoing sexual health concerns. As an unphased trial, this study offers a unique opportunity to contribute to valuable research that could enhance communication and sexual health outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on educational resources rather than medication changes.

What prior data suggests that this educational program is safe for gynecologic cancer patients?

Research shows that programs like the educational one in this trial are generally easy for participants to handle. Previous studies have tested similar programs that help cancer survivors discuss sexual health, and these studies found no major safety issues or negative effects.

Since this trial focuses on education and communication, not on drugs or medical procedures, the risks remain very low. Participants will watch a video, complete a workbook, and have some discussions recorded. These activities are safe and have no known harmful effects.

Overall, the educational method used in this trial poses a low risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on improving communication around sexual health for individuals with gynecologic cancers, an area often overlooked in standard care. Unlike typical treatments that might not address sexual well-being directly, this trial provides a comprehensive resource guide and introduces a unique communication strategy through a video and workbook. These tools aim to empower patients to effectively discuss sexual health concerns with their care providers, potentially leading to better overall quality of life and more personalized care. By addressing this critical aspect of patient health, the trial could fill a significant gap in current gynecologic cancer management.

What evidence suggests that this educational program and resource booklet could be effective for gynecologic cancer patients?

Research has shown that survivors of gynecologic cancer can benefit from programs that facilitate discussions about sexual health. In this trial, one group of participants will receive a resource guide on sexual health and gynecologic cancer. Another group will receive the same guide, along with the "Starting the Conversation" video and workbook, designed to assist patients in discussing sexual health with their doctors. Participants in similar programs have improved communication skills with healthcare providers and felt more comfortable discussing sexual health topics. Additionally, discussions with trained nurses about sexual health concerns have helped women who have undergone gynecologic cancer treatment. These findings suggest that educational programs and resources can effectively assist patients in discussing sexual health issues with their care team. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with gynecologic cancers who are interested in improving communication about sexual health with their cancer care providers. Participants must be willing to have their clinic visits recorded and complete several surveys, including one 6 months after the visit.

Inclusion Criteria

Score of at least 3 on a sexual concerns screener question

I am currently being treated for or finished treatment for gynecologic cancer within the last 10 years.

Attending visits in follow-up care at Fox Chase Cancer Center

Exclusion Criteria

I do not consent to have my clinic visits audio recorded.

Overt cognitive dysfunction or psychiatric disturbance

My condition limits my ability to care for myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either a resource guide alone or a resource guide plus an educational video and workbook to improve communication about sexual health

2 weeks

1 visit (in-person)

Follow-up

Participants complete surveys to assess communication, anxiety, and sexual function at multiple time points

6 months

Surveys at baseline, 2 weeks, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Communication About Sexual Health

Trial Overview The study is testing whether an educational video and workbook can enhance discussions between patients with gynecologic cancers and their clinicians regarding sexual health, compared to just receiving a resource booklet. It also examines the impact on sexual function, anxiety, and depression.

How Is the Trial Designed?

Group I: Sexual Health Resources + Starting the Conversation Video/Workbook Experimental Treatment 2 Interventions

Participants will receive a resource guide on sexual health and gynecologic cancer and will be asked to watch a 25-minute video with information about sexual health and gynecologic cancer and learn ways to talk to their cancer care provider effectively about sexual health concerns. Participants will also fill out a workbook with activities to help them practice communication skills and plan their discussion.

Group II: Sexual Health Resources Alone Active Control 1 Intervention

Participants will receive a resource guide with information on sexual health and gynecologic cancer. The guide will include organizational resources and links to websites with information about sexual health and gynecologic cancer.

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 155 gynecologic cancer survivors, 44.5% reported experiencing sexual dysfunction, highlighting a significant concern for this population.

Black survivors were found to be three times more likely to experience sexual dysfunction compared to white survivors, and those who underwent chemotherapy and radiation therapy had an increased risk of sexual dysfunction as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of sexual dysfunction with race in women with gynecologic malignancies. Frimer, ., Turker, LB., Shankar, V., et al.[2022]

The study evaluates the efficacy of a virtual couple-based intervention called Opening the Conversation (OC) for young adult couples dealing with reproductive and sexual health concerns after breast or gynecologic cancer, involving 100 couples aged 18-44.

The primary outcomes focus on reducing reproductive and sexual distress, with secondary outcomes assessing communication, relationship quality, and overall quality of life, highlighting the need for effective interventions in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opening the Conversation: study protocol for a Phase III trial to evaluate a couple-based intervention to reduce reproductive and sexual distress among young adult breast and gynecologic cancer survivor couples. Gorman, JR., Lyons, KS., Harvey, SM., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06904339

Communication About Sexual Health in Gynecologic Cancer The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36604391/

randomized pilot trial of an intervention to promote effective ... We pilot tested Starting the Conversation (STC), a theory-guided intervention aimed at facilitating survivors' clinical communication about sexual health.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24043834

Sexual Health as Part of Gynecologic Cancer Care Thirty-seven percent received treatment within the last month, 55% were in a relationship, and 35% were sexuality active. Thirty-four percent reported sexuality ...

4. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1111/aogs.14749

Gynecological cancer survivors' experiences with sexual ... Women who have undergone treatment for gynecological cancer benefited from communicating with trained nurses about sexual health concerns.

5. prevention.cancer.gov prevention.cancer.gov/funding-and-grants/funded-grants/R01CA285674

Funded Grants | Division of Cancer Prevention Promoting Effective Clinical Communication about Sexual Health after Gynecologic Cancer: A Randomized Controlled Trial of a Patient-Focused Intervention. Sexual ...

6. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct06904339

Communication About Sexual Health in Gynecologic Cancer The goal of this clinical trial is to learn if an educational video and workbook can help gynecologic cancer patients talk to their cancer providers about ...

7. ascopubs.org ascopubs.org/doi/10.1200/EDBK-25-472856

Enhancing Sexual Health for Cancer Survivors Sexual health concerns are reported in up to 90% of gynecologic cancer survivors, 75%-90% of breast cancer survivors, 77% of female lung cancer ...