The Better, Harder, Faster, Stronger Study (NCT07220512) | Clinical Trial Compass
RecruitingNot Applicable
The Better, Harder, Faster, Stronger Study
United States35 participantsStarted 2025-07-28
Plain-language 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 endometrial cancer.
Who can participate
Age range55 Years
SexFEMALE
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Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Change in electronic frailty index (eFI)
Timeframe: From pre- Neoadjuvant Chemotherapy (NACT; no later than 60 days after consent) to post-NACT (no later than 30 days after completion of the last cycle of NACT)