Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT07335302

Conditions

Psychological Distress

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Psychological Distress

Study ID

NCT07335302

Start date

Dec 18, 2025

Status verified date

Jul, 2026

Completion date

Oct 20, 2028

Anticipated

Primary completion date

Oct 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Safety and Adverse Events (AEs). [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Ann H Klopp, MD, PHD

(713) 563-2444aklopp@mdanderson.org

Locations

The University of Texas M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ann H Klopp, MD, PHD

713-563-2444aklopp@mdanderson.org

Principal Investigator:

Ann H Klopp, MD, PHD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-16.