Pelvic Exam Tool for Gynecologic Cancer Survivors

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

22 Participants Needed

Trial Summary

What is the purpose of this trial?

The two goals of this study are to establish a standardized method of assessing the pelvic floor for patients undergoing pelvic radiation and to determine the feasibility of inverse-RT planning using MRI to identify dosimetric constraints of the pelvic floor musculature for use in radiation planning. The investigators hypothesize that an exam-based diagnostic tool will provide more information about the areas of injury related to pelvic radiation than patient-reported outcomes, and could be used in future studies of preventive strategies. An exam-based tool will also allow measurement of the pain dose-response to radiation treatment of specific areas, which could be excluded from radiation fields during treatment planning.

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.

Is the pelvic exam generally safe for gynecologic cancer survivors?

The pelvic exam is a common procedure used to check for gynecologic issues, but there is limited data on its benefits and harms. It is generally considered safe when done based on medical history or symptoms, and the decision to perform it should be made together with a healthcare provider. ^{1 2 3 4 5}

How does the Pelvic Exam Tool for Gynecologic Cancer Survivors differ from other treatments?

The Pelvic Exam Tool for Gynecologic Cancer Survivors is unique because it focuses on addressing sexual health and intimacy concerns, which are often unmet needs for survivors. Unlike standard treatments that primarily target cancer itself, this tool aims to improve quality of life by supporting sexual well-being and partner relationships after cancer treatment. ^{2 6 7 8 9}

Research Team

Tyler McKinnish, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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 18 years old or older.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

References

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

Routine pelvic examination during front-line chemotherapy for ovarian cancer: should it play a role? [2015]

2. Brazil pubmed.ncbi.nlm.nih.gov

Management Strategies for Sexuality Complaints after Gynecologic Cancer: A Systematic Review. [2022]

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

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

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

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

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

Gynecologic Survivorship Tool: Development, Implementation, and Symptom Outcomes. [2023]

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

A systematic review of sexual concerns reported by gynecological cancer survivors. [2022]

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

Long-term survival from gynecologic cancer: psychosocial outcomes, supportive care needs and positive outcomes. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Redefining sexual health after gynaecological cancer: Lived experiences from Gynea, a digital rehabilitation programme. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Adjusting to sex and intimacy: Gynecological cancer survivors share about their partner relationships. [2021]