Status:
RECRUITING
The Better, Harder, Faster, Stronger Study
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Atrium Health Wake Forest Baptist
Conditions:
Frailty at Older Adults
Ovarian Cancer
Eligibility:
FEMALE
55+ years
Brief Summary
The purpose of this study is to evaluate changes in the electronic Frailty Index (eFI) score following 3-4 cycles of neoadjuvant chemotherapy (NACT) in participants with advanced ovarian and endometri...
Detailed Description
This observation study is designed investigate changes in frailty and cognitive function in participants with advanced ovarian and endometrial cancer before and after undergoing NACT. Changes in frai...
Eligibility Criteria
Inclusion
- Ability to understand and willingness to sign an IRB-approved informed consent.
- Age \> 55 years at the time of enrollment.
- Newly diagnosed suspected ovarian/primary peritoneal/fallopian tube carcinoma of any histological subtype, FIGO Stage II-IV, per enrolling investigator, or newly diagnosed suspected endometrial carcinoma of any histologic subtype, FIGO Stage II-IV, per enrolling investigator.
- Planned for 3 or 4 cycles of NACT, with interval cytoreductive surgery planned thereafter.
- Ability to read, understand, and write the English language.
- As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study.
Exclusion
- History of brain metastases.
- History of poorly controlled psychiatric conditions, defined as hospitalization within the prior 3 months for psychiatric disorders, traumatic brain injury, cerebrovascular event, or dementia, per the enrolling investigator.
- Use of anti-amyloid agents, cholinesterase inhibitors, or glutamate regulators at the time of enrollment.
- Vision impairment that would impede completion of study assessments, per enrolling investigator.
Key Trial Info
Start Date :
July 28 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT07220512
Start Date
July 28 2025
End Date
May 1 2027
Last Update
October 24 2025
Active Locations (1)
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1
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157