The Better, Harder, Faster, Stronger Study

N/ARecruitingNCT07220512

Wake Forest University Health Sciences35 enrolled

Overview

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.

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 frailty and cognitive function will be measured using the eFI which is an automated EMR-based tool based that uses a combination of clinical encounters, diagnosis codes, laboratory workups, and Medicare annual wellness visit data as markers of frailty status. Participants with either ovarian/primary peritoneal/fallopian tube carcinoma or endometrial carcinoma will be approached for interest in participating in this study. Prior to the first prechemotherapy appointment, eFI will be collected as well as PROs (Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog), Patient Health Questionnaire-2 and MoCA (Montreal Cognitive Assessment)) and historical data. After 3-4 rounds of NACT, eFI, FACT-Cog and MoCA will be collected again. Data on intra-operative and post-operative complications will be collected after surgery.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

data collectionOTHER

PROs, historical and longitudinal data collection and eFI calculation

Eligibility

Sex: FEMALEMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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

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

eFI scores are categorized into fit/pre-frail and frail category using the cut of point 0.21

Time frame: 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

A MoCA score of 25 or less is used to define cognitive dysfunction

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

Prevalence of patient-reported cognitive dysfunction

A FACT-Cog PCI score of less than 54 is used to define cognitive dysfunction

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

Changes in cognitive function as measured by MoCA

Changes in cognitive function are calculated based on changes in MoCA before and after NACT

Time frame: 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

Central Contacts

Sydney McEntire, RN

CONTACT

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

Data from ClinicalTrials.gov

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