CARE-BI:a Pilot Study to Improve Patient Comfort and Reduce Psychological Distress During IA Removal

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Psychological Distress

Study type: Observational

Funder types: Other

Identifiers

NCT07335302

2025-1702

NCI-2025-09343 (Other Identifier)

Details and patient eligibility

About

The goal of this research study is to learn about the rate of posttraumatic stress disorder (PTSD) experienced by women after undergoing gynecologic brachytherapy.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Capable of signing informed consent
• Age ≥ 18 years old
• Receipt of multiple intracavitary brachytherapy treatments for gynecologic cancer
• Capable of completing PRO and patient satisfaction surveys and willing to comply with completion of surveys multiple times throughout and after treatment

Exclusion criteria

• Patients without ability to sign informed consent
• Patients unwilling or unable to complete PRO and patient satisfaction surveys at the times required by the study