The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
Location status: Recruiting
Location contact
Ann H Klopp, MD, PHD
CONTACT
Ann H Klopp, MD, PHD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07335302
The goal of this research study is to learn about the rate of posttraumatic stress disorder (PTSD) experienced by women after undergoing gynecologic brachytherapy.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Houston, Texas, 77030, United States
Location status: Recruiting
Ann H Klopp, MD, PHD
CONTACT
Ann H Klopp, MD, PHD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Contact information is provided by the study sponsor or research team.
M.D. Anderson Cancer Center
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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