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

Trial Summary

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 data supports the effectiveness of the treatment Communication About Sexual Health for gynecologic cancer patients?

Research shows that interventions like Starting the Conversation can help gynecologic cancer survivors talk more openly about sexual health with their doctors, which is important for improving their quality of life. Additionally, educational resources have been developed and tested to support patients in understanding how cancer treatment affects their sex life, highlighting the importance of addressing sexual health in patient care. ^{1 2 3 4 5}

Is the treatment 'Communication About Sexual Health' safe for humans?

The research does not provide specific safety data for the treatment 'Communication About Sexual Health,' but it focuses on improving communication about sexual health for gynecologic cancer survivors, which is generally considered safe as it involves discussions rather than medical interventions. ^{2 4 6 7 8}

How is the sexual health resource treatment for gynecologic cancers unique?

This treatment is unique because it focuses on addressing the often-overlooked aspect of sexual health in gynecologic cancer care, providing education and support to improve quality of life and relationships for patients. It is developed from patient-focused research and aims to integrate sexual health as an essential part of patient-centered care. ^{1 3 9 10 11}

What is the purpose of this trial?

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 sexual health concerns. The main questions it aims to answer are: 1. Do gynecologic cancer patients who take part in the educational program and get a resource booklet talk to their cancer clinicians more about sexual health concerns than patients who get a resource booklet alone? 2. Do gynecologic cancer patients who take part in the educational program and get a resource booklet have better sexual function and less anxiety and depression than patients who get a resource booklet alone? Researchers will compare those who get the educational program and the resource booklet to those who get the resource booklet alone. Participants will: 1. Fill out a consent form and survey 2. Have their next clinic visit audio recorded 3. Fill out another survey right after their clinic visit 4. Fill out a final survey 6 months after their clinic visit

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluating a Sexual Health Patient Education Resource. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Starting the Conversation: randomized pilot trial of an intervention to promote effective clinical communication about sexual health for gynecologic cancer survivors. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Sexual Health as Part of Gynecologic Cancer Care: What Do Patients Want? [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Gynecologic radiation oncology patients report unmet needs regarding sexual health communication with providers. [2020]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Sexuality and Menopause: Unique Issues in Gynecologic Cancer. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The association of sexual dysfunction with race in women with gynecologic malignancies. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical Practice Strategies to Address Sexual Health in Female Cancer Survivors. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Sexual dysfunction in patients with gynecologic neoplasms: a retrospective pilot study. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Sexual function after treatment for gynecological malignancy. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Development of a patient education resource for women with gynecologic cancers: cancer treatment and sexual health. [2014]