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Observational Study on Frailty and Cognitive Function in Ovarian and Endometrial Cancer

This observational study, called "The Better, Harder, Faster, Stronger Study," is looking at how frailty and thinking abilities change in older women with advanced ovarian or endometrial cancer who are receiving neoadjuvant chemotherapy (NACT). NACT is chemotherapy given before surgery. Researchers will collect information about your health and complete surveys before you start NACT and again after you finish 3-4 cycles of NACT. The main goal is to see how your electronic Frailty Index (eFI) score changes during this time. This study is for women over 55 who have been recently diagnosed with advanced ovarian or endometrial cancer. The study aims to enroll 35 participants.

Study design
This is an observational study, meaning researchers will collect information without giving you a specific treatment. It plans to include 35 women.
What's involved
You would complete surveys and have health information collected before starting chemotherapy and again after 3-4 cycles of chemotherapy. Data on complications after surgery will also be collected.
Compensation
Not stated in the trial record.
Follow-up
Your electronic Frailty Index (eFI) will be measured from before neoadjuvant chemotherapy (no later than 60 days after consent) to after neoadjuvant chemotherapy (no later than 30 days after completing the last cycle).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07220512

The Better, Harder, Faster, Stronger Study

Recruiting
Not specifiedAges 55+Observational
Wake Forest University Health Sciences
~35 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:data collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in electronic frailty index (eFI)
Measured over 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)

Conditions

Frailty at Older Adults
Ovarian Cancer
Endometrial Cancer
Cognitive Dysfunction
Neoadjuvant Chemotherapy

Explore related trials

Cognitive DysfunctionEndometrial CarcinomaFrailtyMalignant Ovarian Neoplasm

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Anna Kuan-Celarier, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Sydney McEntire, RN
[email protected]
336-713-5879
Email the study team

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Do you actually qualify for this trial?

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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 Memantine for Alzheimers/cognitive impairment, at the time of enrollment.
Vision impairment that would impede completion of study assessments, per enrolling investigator.

What this trial measures

  • Change in electronic frailty index (eFI)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)

    eFI is an automated electronic medical record-based tool based on a deficit accumulation model of frailty that uses a combination of clinical encounters, diagnosis codes, laboratory workups, and Medicare annual wellness visit data as markers of frailty status.