NCT07335302

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
30mo left

Started Dec 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Dec 2025Oct 2028

Study Start

First participant enrolled

December 18, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2028

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

January 9, 2026

Last Update Submit

January 9, 2026

Conditions

Psychological Distress

Outcome Measures

Primary Outcomes (1)

  • Safety and Adverse Events (AEs).

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Through study completion; an average of 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MD Anderson Cancer Center

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

Study Officials

  • Ann H Klopp, MD, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann H Klopp, MD, PHD

CONTACT

(713) 563-2444aklopp@mdanderson.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 13, 2026

Study Start

December 18, 2025

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

October 20, 2028

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations

US(1)