Endometrial CarcinomaNCT04634617
Pelvic Floor Dysfunction and Quality of Life in Uterine Cancer Survivors
An observational study of Endometrial Carcinoma and Malignant Uterine Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies pelvic floor dysfunction and quality of life in uterine cancer survivors. Using questionnaires may help researchers learn more about the sexual function and quality of life in uterine cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Carcinoma, Malignant Uterine Neoplasm, Uterine Corpus Cancer
- What is being tested?
- Questionnaire Administration
- How many people
- 310 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2020to 11 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with uterine cancer treated with surgery +/- radiation at MD Anderson between 2006 and 2017 and patients who have never been diagnosed with any cancer other than non-melanomatous skin cancers and have undergone hysterectomy/bilateral-salpingo-oophorectomy (BSO) for benign reasons between 2006 and 2017
Who may be able to join
- Patients with uterine cancer (including endometrial and uterine carcinoma or sarcoma) treated with surgery +/- radiation at MD Anderson between 2006 and 2017
- Eligible surgeries include laparoscopic or robotic assisted abdominal total hysterectomy, total abdominal hysterectomy, and vaginal hysterectomy with or without pelvic node dissection, with or without omentectomy or omental biopsies
- In addition, patients must have had all WITH bilateral-salpingo-oophorectomy (BSO), either during their surgery or in a previous or subsequent (within 3 months of endometrial cancer diagnosis) surgery
- Patients have had at least one year of follow-up
- Patients have not had any recurrence of disease
- Patients must be able to complete the survey of their own volition
Show all 11Show fewer
- Patients must be able to read and speak English fluently
- CONTROL GROUP: Patients have never been diagnosed with any cancer other than non-melanomatous skin cancers
- CONTROL GROUP: Patient has undergone hysterectomy/BSO for benign reasons between 2006 and 2017
- CONTROL GROUP: Patients must be able to complete the survey of their own volition
- CONTROL GROUP: Patients must be able to speak and read English fluently
Who cannot join
- Patients with cancer recurrence, as this will affect their current quality of life
- Patients with additional pelvic surgery at the time of their hysterectomy (for example pelvic exenteration, urostomy placement, etc.)
- Patients with a secondary primary cancer (including cervical cancer), as this will affect their current quality of life. Patients may have either squamous cell or basal cell carcinoma of the skin
- Neurocognitive deficits that render patients unable to complete the survey on their own
- Patients who have not yet had removal of their bilateral ovaries
- Preoperative radiotherapy prior to hysterectomy
Trial locations and contacts
1 site in 1 country.
About this study
This trial studies pelvic floor dysfunction and quality of life in uterine cancer survivors. Using questionnaires may help researchers learn more about the sexual function and quality of life in uterine cancer survivors.
Read the detailed description
PRIMARY OBJECTIVE:
- To estimate and compare the prevalence of pelvic floor dysfunction in uterine cancer survivors by modality of treatment and to compare with a control group with no history of cancer using the Pelvic Floor Distress Inventory (PFDI).
SECONDARY OBJECTIVES:
- To compare the degree of sexual dysfunction in uterine cancer survivors by modality of treatment using the Female Sexual Function Index (FSFI) as a continuous measure, and to compare to a non-cancer control group.
II. To compare the long term quality of life (QoL) (using the FSFI, the Pelvic Floor Impact Questionnaire [PFIQ], Functional Assessment of Cancer Therapy-Endometrial Cancer [FACT-En], Brief Pain Inventory [BPI], Alzheimer's Disease Assessment Scale [ADAS]/Cancer Rehabilitation Evaluation System for Research [CARES] dating scale and Menopausal survey) of patients who were treated with surgery and radiotherapy versus surgery alone (with or without chemotherapy), and to compare to a control group with no history of cancer.
III. To evaluate associations between dose volume parameters of organs at risk and pelvic floor symptoms using the PFIQ and PFDI.
IV. To evaluate associations between the radiation and surgical technique and quality of life (including pelvic symptoms and sexual function using the FSFI, PFIQ, PFDI, and FACT-En).
OUTLINE:
Patients complete questionnaires over 45-60 minutes consisting of demographic, treatment, lifestyle, disease, and comorbidity questions, as well as multiple study instruments assessing quality of life as it pertains to common toxicities of uterine cancer treatment.
- Conditions
- Endometrial Carcinoma, Malignant Uterine Neoplasm, Uterine Corpus Cancer, Uterine Corpus Sarcoma
- Being tested
- Questionnaire Administration
- Medical subject headings
- Endometrial Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Observational (questionnaires) | Patients complete questionnaires over 45-60 minutes consisting of demographic, treatment, lifestyle, disease, and comorbidity questions, as well as multiple study instruments assessing quality of life as it pertains to common toxicities of uterine cancer treatment. Receives: Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor distress (PFD)
Measured by the Pelvic Floor Distress Inventory-20. Descriptive statistics (i.e. frequencies, percentages, medians, ranges, means, standard deviations, measures of skewness and kurtosis), including 95% confidence intervals (CIs) will be computed for the measures derived by study cohort. Prevalence estimates along with exact 95% CIs will be computed. Logistic regression analysis will be used to assess the odds of PFD for treatment cohorts relative to the cohort of patient controls.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start9 Jan 2020
- Primary completion11 Apr 2027 (estimated)
- Study completion11 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lilie L Lin, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634617
- Sponsor's protocol ID
- 2018-0242
- Other IDs
- NCI-2019-08260, 2018-0242
- Status last verified
- May 2026
- First submitted
- 9 Nov 2020
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Dysfunction and Quality of Life in Uterine Cancer Survivors
- ClinicalTrials.gov ID
- NCT04634617
- Acronym / sponsor ID
- 2018-0242
- Conditions
- Endometrial Carcinoma, Malignant Uterine Neoplasm, Uterine Corpus Cancer, Uterine Corpus Sarcoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 310 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 11 Apr 2027 (estimated)
- Study completion
- 11 Apr 2027 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies pelvic floor dysfunction and quality of life in uterine cancer survivors. Using questionnaires may help researchers learn more about the sexual function and quality of life in uterine cancer survivors.
Detailed description
PRIMARY OBJECTIVE:
- To estimate and compare the prevalence of pelvic floor dysfunction in uterine cancer survivors by modality of treatment and to compare with a control group with no history of cancer using the Pelvic Floor Distress Inventory (PFDI).
SECONDARY OBJECTIVES:
- To compare the degree of sexual dysfunction in uterine cancer survivors by modality of treatment using the Female Sexual Function Index (FSFI) as a continuous measure, and to compare to a non-cancer control group.
II. To compare the long term quality of life (QoL) (using the FSFI, the Pelvic Floor Impact Questionnaire [PFIQ], Functional Assessment of Cancer Therapy-Endometrial Cancer [FACT-En], Brief Pain Inventory [BPI], Alzheimer's Disease Assessment Scale [ADAS]/Cancer Rehabilitation Evaluation System for Research [CARES] dating scale and Menopausal survey) of patients who were treated with surgery and radiotherapy versus surgery alone (with or without chemotherapy), and to compare to a control group with no history of cancer.
III. To evaluate associations between dose volume parameters of organs at risk and pelvic floor symptoms using the PFIQ and PFDI.
IV. To evaluate associations between the radiation and surgical technique and quality of life (including pelvic symptoms and sexual function using the FSFI, PFIQ, PFDI, and FACT-En).
OUTLINE:
Patients complete questionnaires over 45-60 minutes consisting of demographic, treatment, lifestyle, disease, and comorbidity questions, as well as multiple study instruments assessing quality of life as it pertains to common toxicities of uterine cancer treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (questionnaires) | – | Other: Questionnaire AdministrationPatients complete questionnaires over 45-60 minutes consisting of demographic, treatment, lifestyle, disease, and comorbidity questions, as well as multiple study instruments assessing quality of life as it pertains to common toxicities of uterine cancer treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with uterine cancer treated with surgery +/- radiation at MD Anderson between 2006 and 2017 and patients who have never been diagnosed with any cancer other than non-melanomatous skin cancers and have undergone hysterectomy/bilateral-salpingo-oophorectomy (BSO) for benign reasons between 2006 and 2017
Key inclusion criteria (11 listed)
- Patients with uterine cancer (including endometrial and uterine carcinoma or sarcoma) treated with surgery +/- radiation at MD Anderson between 2006 and 2017
- Patients have had at least one year of follow-up
- Patients have not had any recurrence of disease
- Patients must be able to complete the survey of their own volition
- Patients must be able to read and speak English fluently
Key exclusion criteria (6 listed)
- Patients with cancer recurrence, as this will affect their current quality of life
- Patients with additional pelvic surgery at the time of their hysterectomy (for example pelvic exenteration, urostomy placement, etc.)
- Patients with a secondary primary cancer (including cervical cancer), as this will affect their current quality of life. Patients may have either squamous cell or basal cell carcinoma of the skin
- Neurocognitive deficits that render patients unable to complete the survey on their own
- Patients who have not yet had removal of their bilateral ovaries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire AdministrationComplete questionnaires | Other | Observational (questionnaires) |
Primary outcome
Pelvic floor distress (PFD)
Time frame: Up to 1 year
Measured by the Pelvic Floor Distress Inventory-20. Descriptive statistics (i.e. frequencies, percentages, medians, ranges, means, standard deviations, measures of skewness and kurtosis), including 95% confidence intervals (CIs) will be computed for the measures derived by study cohort. Prevalence estimates along with exact 95% CIs will be computed. Logistic regression analysis will be used to assess the odds of PFD for treatment cohorts relative to the cohort of patient controls.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Endometrial Carcinoma
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilie L Lin principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Carcinoma and Malignant Uterine Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor distress (PFD) (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.