Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-06 @ 10:04 AM
Study NCT ID:
NCT07335302
Status:
RECRUITING
Last Update Posted:
2026-01-13
First Post:
2026-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CARE-BI:a Pilot Study to Improve Patient Comfort and Reduce Psychological Distress During IA Removal
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
CARE-BI (Comfort and Analgesia for Removal of Brachytherapy Implants): a Pilot Study to Improve Patient Comfort and Reduce Psychological Distress During Intracavitary Applicator Removal
Status:
RECRUITING
Status Verified Date:
2026-01
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:
The goal of this research study is to learn about the rate of posttraumatic stress disorder (PTSD) experienced by women after undergoing gynecologic brachytherapy.
Detailed Description:
Primary Objective:
To assess the rate of PTSD experienced by women at MD Anderson after receipt of gynecologic brachytherapy as per scores on the Impact of Event Scale - Revision (IES-R)
Secondary Objective:
To evaluate whether rates of Acute Stress Disorder (ASD) and Posttraumatic Stress Disorder (PTSD) are associated with factors including pain during implant removal as per the Brief Pain Inventory (BPI), residual pain after treatment completion per hospital readmission rates for uncontrolled pain, elevated treatment related anxiety and depression per Hospital Anxiety and Depression Scale (HADS), overall quality of life per the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 with the accompanying Cervical Cancer 24 Module (EORTC QLQ-C30 CX24), and propofol use per patient request.
To assess the rate of PTSD experienced by women at MD Anderson after receipt of gynecologic brachytherapy as per scores on the Impact of Event Scale - Revision (IES-R)
Secondary Objective:
To evaluate whether rates of Acute Stress Disorder (ASD) and Posttraumatic Stress Disorder (PTSD) are associated with factors including pain during implant removal as per the Brief Pain Inventory (BPI), residual pain after treatment completion per hospital readmission rates for uncontrolled pain, elevated treatment related anxiety and depression per Hospital Anxiety and Depression Scale (HADS), overall quality of life per the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 with the accompanying Cervical Cancer 24 Module (EORTC QLQ-C30 CX24), and propofol use per patient request.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-09343 | OTHER | NCI-CTRP Clinical Trials Registry | View |