Pelvic Exam Tool for Gynecologic Cancer Survivors
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
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.
12345How 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.
26789Eligibility 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.
+3 more
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.
+5 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Single-digit pelvic examExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Washington University School of MedicineSaint Louis, MO
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Who Is Running the Clinical Trial?
Washington University School of MedicineLead Sponsor
References
Routine pelvic examination during front-line chemotherapy for ovarian cancer: should it play a role? [2015]To determine if pelvic examination affected management in patients undergoing first-line chemotherapy for ovarian cancer and to determine a threshold of change in tumor size reliably detectable by pelvic examination.
Management Strategies for Sexuality Complaints after Gynecologic Cancer: A Systematic Review. [2022]To explore the main sexuality complaints of gynecologic cancer survivors after treatment and to identify the care strategies provided.
ACOG Committee Opinion No. 754: The Utility of and Indications for Routine Pelvic Examination. [2021]The pelvic examination has long been considered a fundamental component of the well-woman visit, and many women and gynecologic care providers view this visit as an opportunity to discuss sexual and reproductive health issues. Traditionally, a pelvic examination is performed for asymptomatic women as a screening tool for gynecologic cancer, infection, and asymptomatic pelvic inflammatory disease; some obstetrician-gynecologists and patients consider it important in detecting subclinical disease, despite evidence to the contrary. Given changes in screening recommendations and the ability to screen for sexually transmitted infections using less-invasive methods, reevaluation of the role of the pelvic examination for asymptomatic, nonpregnant women is warranted. A limited number of studies have evaluated the benefits and harms of a screening pelvic examination for detection of ovarian cancer, bacterial vaginosis, trichomoniasis, and genital herpes. Data from these studies are inadequate to support a recommendation for or against performing a routine screening pelvic examination among asymptomatic, nonpregnant women who are not at increased risk of any specific gynecologic condition. It is recommended by the American College of Obstetricians and Gynecologists that pelvic examinations be performed when indicated by medical history or symptoms. Women with current or a history of cervical dysplasia, gynecologic malignancy, or in utero diethylstilbestrol exposure should be screened and managed according to guidelines specific to those gynecologic conditions. Based on the current limited data on potential benefits and harms and expert opinion, the decision to perform a pelvic examination should be a shared decision between the patient and her obstetrician-gynecologist or other gynecologic care provider.
ACOG Committee Opinion No. 754 Summary: The Utility of and Indications for Routine Pelvic Examination. [2019]The pelvic examination has long been considered a fundamental component of the well-woman visit, and many women and gynecologic care providers view this visit as an opportunity to discuss sexual and reproductive health issues. Traditionally, a pelvic examination is performed for asymptomatic women as a screening tool for gynecologic cancer, infection, and asymptomatic pelvic inflammatory disease; some obstetrician-gynecologists and patients consider it important in detecting subclinical disease, despite evidence to the contrary. Given changes in screening recommendations and the ability to screen for sexually transmitted infections using less-invasive methods, reevaluation of the role of the pelvic examination for asymptomatic, nonpregnant women is warranted. A limited number of studies have evaluated the benefits and harms of a screening pelvic examination for detection of ovarian cancer, bacterial vaginosis, trichomoniasis, and genital herpes. Data from these studies are inadequate to support a recommendation for or against performing a routine screening pelvic examination among asymptomatic, nonpregnant women who are not at increased risk of any specific gynecologic condition. It is recommended by the American College of Obstetricians and Gynecologists that pelvic examinations be performed when indicated by medical history or symptoms. Women with current or a history of cervical dysplasia, gynecologic malignancy, or in utero diethylstilbestrol exposure should be screened and managed according to guidelines specific to those gynecologic conditions. Based on the current limited data on potential benefits and harms and expert opinion, the decision to perform a pelvic examination should be a shared decision between the patient and her obstetrician-gynecologist or other gynecologic care provider.
Gynecologic Survivorship Tool: Development, Implementation, and Symptom Outcomes. [2023]To describe the development and implementation of a new digital health clinical tool (Gynecologic Survivorship Tool [GST]) for symptom management of women surgically treated for gynecologic cancer; to assess its feasibility; and to conduct a retrospective review of the data.
A systematic review of sexual concerns reported by gynecological cancer survivors. [2022]To identify physical, psychological and social sexual concerns reported by gynecological (GYN) cancer survivors.
Long-term survival from gynecologic cancer: psychosocial outcomes, supportive care needs and positive outcomes. [2022]To assess the long-term psychosocial outcomes and supportive care needs of gynecologic cancer survivors.
Redefining sexual health after gynaecological cancer: Lived experiences from Gynea, a digital rehabilitation programme. [2023]Gynaecological cancer illness and treatment have a significant impact on women's sexual health and concerns regarding sexual health are known to be an unmet need in survivors. The digital support programme Gynea was designed to enhance women's health, including sexual health, after gynaecological cancer treatment. This study aimed to explore how cancer survivors experienced participation in Gynea.
Adjusting to sex and intimacy: Gynecological cancer survivors share about their partner relationships. [2021]This study describes what gynecological (GYN) cancer survivors relate about their intimate partners and adjustments in their sexual lives following diagnosis and treatment. Conventional descriptive content analysis was used to examine participant responses about partner relationships following their diagnosis. Responses revealed three clusters and 15 codes of data. Findings report the influence of cancer treatment on sexual activity and functioning, women's sex lives, and their relationships. Health-care providers have a vital role in supporting women and their partners during the cancer care trajectory and should include both the survivor and the partner in conversations focused on sexual concerns and sexual well-being.