Pelvic Exam Tool for Gynecologic Cancer Survivors

No longer recruiting at 1 trial location

Overseen By Tyler McKinnish, M.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must be taking: Radiosensitizing platinum

Must not be taking: Anti-estrogenic hormonal

Disqualifiers: Pelvic radiation, Interstitial cystitis, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks a better method to examine the pelvic floor in patients who have undergone pelvic radiation for cervical cancer. Researchers aim to determine if a hands-on exam, specifically a single-digit pelvic exam (also known as a digital pelvic exam), provides more detailed information on radiation injuries than patient-reported symptoms alone. This approach could influence future treatments by potentially avoiding certain areas during radiation. Eligible participants are English-speaking women currently receiving treatment for locally advanced cervical cancer with a specific type of chemotherapy and without other pelvic conditions like irritable bowel syndrome. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future treatment strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking anti-estrogenic hormonal therapy or being treated for a chronic non-cancer pain condition.

What prior data suggests that this pelvic exam tool is safe for gynecologic cancer survivors?

Research has shown that pelvic exams, such as the single-finger exam in this study, are generally safe for patients. During these exams, a doctor uses one finger to check the pelvic area. Studies have found that most people tolerate these exams well, and serious side effects are rare. However, some patients may experience discomfort or stress, especially if they have undergone many exams before. Patients should inform the healthcare provider of any discomfort during the exam. Overall, the single-finger pelvic exam is considered low-risk when performed by a qualified professional. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the single-digit pelvic exam for gynecologic cancer survivors because it offers a less invasive approach to assessing pelvic floor health. Unlike traditional methods that can be more uncomfortable and intimidating, this technique involves a simpler, more patient-friendly exam. Additionally, by integrating evaluations like the Pelvic Floor Impact Questionnaire and MRI, this method promises a comprehensive look at the patient's condition over time, potentially leading to better-tailored treatments and improved quality of life for survivors.

What evidence suggests that this pelvic exam tool is effective for gynecologic cancer survivors?

Research has shown that pelvic exams can identify issues in the pelvic floor, particularly for those receiving pelvic radiation. Some studies have successfully detected problems in up to 8.7% of cases through these exams. This trial will assess the effectiveness of the single-digit pelvic exam, which participants will undergo at various stages of their treatment. These exams can offer important insights into areas affected by radiation. However, experts continue to debate the exams' effectiveness in reducing cancer-related issues. The exams might help pinpoint specific areas to avoid during treatment, potentially reducing pain and improving outcomes. ^{2 6 7 8 9}

Who Is on the Research Team?

Premal Thaker, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adult English-speaking women undergoing primary treatment for advanced cervical cancer with specific chemotherapy and radiation intended to cure. They must be willing to consent to the study's procedures.

Inclusion Criteria

Prospective Cohort: Able to understand and willing to sign an IRB approved written informed consent document

I am receiving my first treatment for advanced cervical cancer with specific chemotherapy and radiation aimed at curing it.

I had chemoradiotherapy with a platinum agent for advanced cervical cancer.

Exclusion Criteria

I have received pelvic radiation treatment.

I was diagnosed with interstitial cystitis, IBS, or IBD at the start of treatment.

I am not planning to take any anti-estrogenic hormonal therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants undergo pelvic radiation treatment with assessments at multiple time points

6 weeks

3 visits (in-person) at treatment start, mid-point, and end

Follow-up

Participants are monitored for pelvic floor dysfunction and other outcomes after treatment

6 months

1 visit (in-person) at 6 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Single digit pelvic exam

Trial Overview The study aims to create a standard method for assessing pelvic floor health in patients receiving pelvic radiation, using an exam-based tool and MRI planning, which may help avoid radiating sensitive areas.

How Is the Trial Designed?

Group I: Single-digit pelvic exam Experimental Treatment 1 Intervention

* Patients will have a pelvic floor muscle exam performed by their gynecologic radiation oncologist prior to treatment, at treatment mid-point (after 3 weeks of treatment), at the end of treatment (after 6 weeks of treatment), and at a follow-up visit 6 months after the end of treatment. Patients will also complete the Pelvic Floor Impact Questionnaire 7 (PFIQ-7), Pelvic Floor Disability Index (PFDI-20), and the EORTC QLQ-CX24 at these time points. * The patient will also undergo a standard of care MRI prior to starting treatment.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

Gynecological cancer survivors report a wide range of sexual concerns, including physical issues like pain during intercourse and changes in sexual activity, as well as psychological concerns such as decreased libido and anxiety about sexual performance.

While some interventions showed improvements in physical aspects of sexual function, most studies focused primarily on physical issues, highlighting the need for more comprehensive research that addresses psychological and social dimensions of sexual health in these survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of sexual concerns reported by gynecological cancer survivors. Abbott-Anderson, K., Kwekkeboom, KL.[2022]

The Gynea digital support program significantly helped 20 women cancer survivors redefine their sexual health, emphasizing empowerment and communication with partners rather than just sexual function.

Participation in Gynea enhanced women's understanding of their sexual needs, which was crucial for regaining intimacy and sexual integrity in their relationships after gynaecological cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Redefining sexual health after gynaecological cancer: Lived experiences from Gynea, a digital rehabilitation programme. Breistig, S., Thorkildsen, KM., Werner, HMJ., et al.[2023]

Gynecologic cancer survivors commonly experience sexuality complaints such as low libido, vaginal dryness, and pain during intercourse, which can significantly affect their quality of life.

Effective care strategies identified include improved patient-clinician communication, individualized care plans, and the use of pelvic physiotherapy and vaginal moisturizers, which can help alleviate these symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management Strategies for Sexuality Complaints after Gynecologic Cancer: A Systematic Review. Pizetta, LM., Reis, ADC., Méxas, MP., et al.[2022]

A study of 199 gynecologic cancer survivors revealed that while most reported a normal quality of life, nearly one-third experienced clinical levels of anxiety, highlighting the need for ongoing psychological support even years after treatment.

Significant supportive care needs were identified, particularly concerning fear of disease recurrence and existential issues, with nearly 90% of survivors expressing unmet needs, especially among those diagnosed with anxiety or PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term survival from gynecologic cancer: psychosocial outcomes, supportive care needs and positive outcomes. Hodgkinson, K., Butow, P., Fuchs, A., et al.[2022]

Gynecological cancer survivors reported significant changes in their sexual activity and relationships following diagnosis and treatment, highlighting the impact of cancer on intimate partner dynamics.

Healthcare providers play a crucial role in addressing sexual concerns by involving both survivors and their partners in discussions about sexual well-being during the cancer care process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjusting to sex and intimacy: Gynecological cancer survivors share about their partner relationships. Abbott-Anderson, K., Young, PK., Eggenberger, SK.[2021]

The pelvic examination has traditionally been a key part of well-woman visits for screening gynecologic issues, but recent evidence suggests that its routine use for asymptomatic, nonpregnant women may not be necessary, as there is insufficient data to support its effectiveness in detecting conditions like ovarian cancer or infections.

Current guidelines recommend that pelvic examinations should only be performed when there are specific medical indications or symptoms, emphasizing the importance of shared decision-making between patients and their healthcare providers regarding the necessity of the examination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACOG Committee Opinion No. 754: The Utility of and Indications for Routine Pelvic Examination. [2021]

The Gynecologic Survivorship Tool (GST) was successfully implemented for symptom management in women treated for gynecologic cancer, with a high completion rate of 71% from 1,405 patients over a year-long period.

The tool effectively identified common symptoms such as bowel problems and vaginal dryness, allowing healthcare teams to create targeted strategies for symptom relief, demonstrating its feasibility and efficiency in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gynecologic Survivorship Tool: Development, Implementation, and Symptom Outcomes. Carter, J., Abu-Rustum, NR., Saban, S., et al.[2023]

The pelvic examination has traditionally been a key part of well-woman visits for screening gynecologic issues, but recent evidence suggests that its routine use for asymptomatic, nonpregnant women may not be necessary, as there are more effective and less invasive screening methods available.

Current guidelines recommend that pelvic examinations should only be performed when there are specific medical indications or symptoms, emphasizing the importance of shared decision-making between patients and their healthcare providers regarding the need for such examinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACOG Committee Opinion No. 754 Summary: The Utility of and Indications for Routine Pelvic Examination. [2019]

In a study of 47 women undergoing first-line chemotherapy for ovarian cancer, pelvic examinations rarely led to changes in management, with only 10.5% revealing palpable anomalies related to known tumors.

The study found no reliable threshold for detecting changes in tumor size through pelvic examination, suggesting that routine pelvic exams may not significantly enhance clinical management during initial treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine pelvic examination during front-line chemotherapy for ovarian cancer: should it play a role? Argenta, PA., Ormsby, RR., Downs, LS., et al.[2015]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK442158/

Screening for Gynecologic Conditions With Pelvic Examination Focusing on comparable 1-year data from the four studies, the proportion of participants with positive pelvic examination results ranged from 1.2 to 8.7 percent ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6669035/

The use, quality and effectiveness of pelvic examination in ... In a cohort of patients with various gynaecological cancers examination rates varied between 52% for women presenting with vaginal bleeding to ...

3. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2018/10/the-utility-of-and-indications-for-routine-pelvic-examination

The Utility of and Indications for Routine Pelvic Examination Data on its effectiveness for screening for other gynecologic ... The ACP concluded that performing pelvic examinations did not decrease ovarian cancer morbidity ...

4. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/home/getfilebytoken/AnLwG-T96XaL_TCZ6TPcWe

Periodic Screening Pelvic Examination Evidence Report ... In total, 4 studies examined the accuracy of the pelvic examination to detect ovarian cancer in asymptomatic popula- tions, while 1 to 2 studies ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2608228

US Preventive Services Task Force Recommendation ... The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of performing screening pelvic examinations.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK534223/

Gynecologic Pelvic Examination - StatPearls - NCBI Bookshelf The pelvic exam traditionally includes a careful inspection of the external genitalia and a speculum and bimanual exam to assess the internal ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24014427

Evidence and best practices for trauma-informed care in ... 23 Among gynecologic oncology patients, unique stressors that may exacerbate trauma include recurrent pelvic exams, surgery on sensitive anatomical regions, ...

8. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2608227

Periodic Screening Pelvic Examination: Evidence Report ... In total, 4 studies examined the accuracy of the pelvic examination to detect ovarian cancer in asymptomatic populations, while 1 to 2 studies ...

9. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/Page/Document/evidence-summary/gynecological-conditions-screening-with-the-pelvic-examination

Gynecological Conditions: Periodic Screening With the ... Objective: To systematically review literature on health benefits, accuracy, and harms of the screening pelvic examination for gynecologic ...