Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04634617
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2020-11-09
Brief Title:
Pelvic Floor Dysfunction and Quality of Life in Uterine Cancer Survivors
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Pelvic Floor Dysfunction and Quality of Life in Uterine Cancer Survivors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
PRIMARY OBJECTIVE
I 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
I 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 Alzheimers Disease Assessment Scale ADASCancer 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
I 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
I 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 Alzheimers Disease Assessment Scale ADASCancer 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-0242 | OTHER | M D Anderson Cancer Center | None |
| NCI-2019-08260 | REGISTRY | None | None |