CLINICAL TRIAL

Starting the Conversation for Gynecologic Cancers

Recruiting · 18+ · Female · Philadelphia, PA

Women's Health Communication Study

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About the trial for Gynecologic Cancers

Treatment Groups

This trial involves 2 different treatments. Starting The Conversation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Starting the Conversation
BEHAVIORAL
Sexual and Menopausal Health Resources Only
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Sexual and Menopausal Health Resources Only
BEHAVIORAL

Eligibility

This trial is for female patients aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You are attending a clinic visit in the course of follow-up care. show original
You have a diagnosis of any stage (I-IV) gynecologic cancer. show original
You have received treatment for gynecologic cancer or have completed treatment for gynecologic cancer < 10 years ago. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 months.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Starting the Conversation will improve 4 primary outcomes and 9 secondary outcomes in patients with Gynecologic Cancers. Measurement will happen over the course of Baseline.

Feasibility - Enrollment
BASELINE
Study enrollment, defined as the proportion of participants randomized out of the number of eligible patients approached for participants.
BASELINE
Clinical Communication - Discussion of Sexual Health
2 WEEKS
Proportion of patients who discuss sexual health concerns in a clinic visit.
2 WEEKS
Clinical Communication - Raising Topic of Sexual Health
2 WEEKS
Proportion of patients who raise the topic of sexual health concerns in a clinic visit.
2 WEEKS
Acceptability
2 WEEKS
The proportion of participants randomized to receive the Starting the Conversation intervention who endorse at least 6 of 8 core components of the Starting the Conversation Intervention (defined as satisfaction with the intervention, informativeness of the intervention, helpfulness of the intervention, relevance of the intervention, ease of participation, approval of the intervention format, likelihood of recommending the intervention to others, and perceived importance of the intervention for people with gynecologic cancer).
2 WEEKS
Feasibility - Intervention Completion
2 WEEKS
Proportion of participants randomized to receive the Starting the Conversation intervention who report having engaged at least somewhat with the video and/or accompanying workbook.
2 WEEKS
Clinical Communication - Asking a Question About Sexual Health
2 WEEKS
Proportion of patients who ask a question about sexual health concerns in a clinic visit.
2 WEEKS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for gynecologic cancers?

Therapies with strong evidence bases have been more extensively studied than treatments with minimal evidence supporting their use in the clinical routine (weakly supported treatments, such as endometrial ablation.) Therapies in which no clear evidence exists for their benefits (such as GnRH analog therapy and tamoxifen) are less frequently recommended, possibly due to poorer compliance with guidelines or the side effects of these therapies.

Anonymous Patient Answer

What causes gynecologic cancers?

Smoking is the single greatest cause of [cervical cancer](https://www.withpower.com/clinical-trials/cervical-cancer) and the primary cause of cervical cancer in women over 40 years. The primary cause of other gynecologic cancers, including endometrial cancers, fallopian tube cancer, uterine sarcomasia, and vulvar cancer is cigarette smoking.

Anonymous Patient Answer

How many people get gynecologic cancers a year in the United States?

There have been an increasing number of patients diagnosed with gynecologic cancers in the United States, driven by increasing longevity and increasing use of screening tests.

Anonymous Patient Answer

What is gynecologic cancers?

About 7 to 8 million women and girls in the US are diagnosed with gynecologic cancers annually. Although the most common cancers among both women and girls occur in young adulthood, gynecologic cancers are not part of the routine cancer screening recommended by the US Preventive Service Task Force.

Anonymous Patient Answer

Can gynecologic cancers be cured?

For those women with advanced disease, a cure is unlikely. However, for the small number of women who live long enough for cure, this goal is achievable.

Anonymous Patient Answer

What are the signs of gynecologic cancers?

Many women with pelvic, abdominal, or vaginal masses have associated symptoms. A systematic, comprehensive approach helps identify ovarian cancer or adenocarcinoma. The patient and her healthcare provider must be aware of these symptoms and use this information in planning the next steps.

Anonymous Patient Answer

What are the common side effects of sexual and menopausal health resources only?

The sexual and menopausal resources frequently provided in outpatient settings to patients in gynecological oncology can be viewed through a lens of gender stereotypes. In practice, the messages conveyed to the patient can often lead to unintended medical consequences for both patients, especially women; and for clinicians, such as decreased satisfaction of the patient and concern for patient risk. The present study offers a systematic analysis to inform clinicians and women considering sexual and menopausal resources.

Anonymous Patient Answer

Have there been other clinical trials involving sexual and menopausal health resources only?

There is a dearth of studies for MWHS, and almost no studies on the effect of any clinical trials on sexual health. This may be due to the difficulty of conducting research on sexual health. The quality of evidence regarding oral hormonal interventions is weak. Findings from a recent study suggest there may be a dearth of evidence to support the use of MWHS in menopausal women with sexual health problems.

Anonymous Patient Answer

Does gynecologic cancers run in families?

Although the proportion of colorectal or [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)s in family members has been described many times, this is the first study to compare the proportions between those with a family history and those without a family history of gynecological cancers. Although the data reflect a higher proportion of family members with gynecological cancers (i.e., 17.6%) compared with the reported population rate (9.3%), this difference was not statistically significant. This suggests that screening with colonoscopy and breast examination may be a reasonable approach in patients who have a family history of colorectal or breast cancers, but caution must be used in order to avoid a significant overdiagnosis of occult cancers in family members.

Anonymous Patient Answer

Is sexual and menopausal health resources only typically used in combination with any other treatments?

The majority of gynecology residents reported wanting to discuss sexual health resource utilization and had never had their desire met by a reproductive health provider. There could be an opportunity to recruit new providers with a focus on sexual health resources.

Anonymous Patient Answer

How does sexual and menopausal health resources only work?

There is more than adequate support for the provision of sexuality related information and counselling in UK clinics. In a recent study, findings have led us to conclude that there is a need for this counselling to encompass all types of women who are being examined with respect to their sexual and menopausal health-related concerns in an integrated, holistic way.

Anonymous Patient Answer

What is the primary cause of gynecologic cancers?

There appears to be a trend towards an association of [endometrial cancer](https://www.withpower.com/clinical-trials/endometrial-cancer) and colorectal neoplasia, although with a few exceptions including endometrial cancer in women with BRCA1 mutations. There also appears to be an association between Barrett's esophagus with stomach cancer and cervical or anal cancer in the setting of a history of cervical intraepithelial neoplasia or cervical cancer. It is notable that cervical cancer occurs at a high rate after treatment of low-grade lesions with trichomonas vaginalis. Thus, endometrial cancer is considered a "late-appearing" end colorectal cancer. Gastric cancer is an occupational cancer in H.

Anonymous Patient Answer
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