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

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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07335302

Enrollment

Registered

2026-01-13

Start date

2025-12-18

Completion date

2028-10-20

Last updated

2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological Distress

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Safety and Adverse Events (AEs).	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

Countries

United States

Contacts

CONTACTAnn H Klopp, MD, PHD

aklopp@mdanderson.org(713) 563-2444

PRINCIPAL_INVESTIGATORAnn H Klopp, MD, PHD

M.D. Anderson Cancer Center

Outcome results