The Better, Harder, Faster, Stronger Study

NCT07220512 | Recruiting DMC

• 2 other identifiers: IRB00129176ONC-GYN-2401
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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 endometrial cancer.

Conditions

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

Keywords

Frailty; ovarian cancer; endometrial cancer; cognitive dysfunction; neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Change in electronic frailty index (eFI)

  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.

  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)

Secondary Outcomes (6)

• Change in proportion of participants in the fit/pre-frail (eFI score ≤ 0.21) versus frail category (eFi score > 0.21)

  Before and after NACT - At visit 1, no later than 60 days after consent and no later than 30 days after completion of the last cycle of NACT.

• Prevalence of cognitive dysfunction

  Before NACT - At visit 1, no later than 60 days after consent

• Prevalence of patient-reported cognitive dysfunction

  Before NACT - At visit 1, no later than 60 days after consent

• Changes in cognitive function as measured by MoCA

  Before NACT - At visit 1, no later than 60 days after consent and Post-NACT - no later than 30 days after completion of the last cycle of NACT

• Changes in cognitive function as measured by FACT-Cog PCI

  Before NACT - At visit 1, no later than 60 days after consent and Post-NACT - no later than 30 days after completion of the last cycle of NACT

Other Outcomes (5)

• Length of hospital stay

  Post-NACT - no later than 30 days after completion of the last cycle of NACT

• Surgical complication

  Post-NACT - no later than 30 days after completion of the last cycle of NACT

• Discharge disposition home vs. rehabilitation facility

  Post-NACT - no later than 30 days after completion of the last cycle of NACT

Study Arms (1)

Participants with ovarian or endometrial carcinoma with planned NACT.

Participants over 55 years old with either ovarian/primary peritoneal/fallopian tube carcinoma or endometrial carcinoma

Other: data collection

Interventions

data collection OTHER

PROs, historical and longitudinal data collection and eFI calculation

Participants with ovarian or endometrial carcinoma with planned NACT.

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 55 or older seen in clinic with either ovarian/primary peritoneal/fallopian tube carcinoma or endometrial carcinoma who are planned for NACT

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Wake Forest Baptist: collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Cognitive Dysfunction; Frailty

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Anna Kuan-Celarier, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sydney McEntire, RN

CONTACT

336-713-5879; sydney.mcentire@advocatehealth.org

Study Design

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

Study Record Dates

• First Submitted: October 13, 2025
• First Posted: October 24, 2025
• Study Start: July 28, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 24, 2025

Record last verified: 2025-10

Locations

US (1)