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NCT Number: NCT07335302

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

[email protected]

713-563-2444

Ann H Klopp, MD, PHD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Safety and Adverse Events (AEs).

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Ann H Klopp, MD, PHD

CONTACT

[email protected]

(713) 563-2444

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jan 13, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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