The Better, Harder, Faster, Stronger Study

Wake Forest University (WFU)

Status

Enrolling

Conditions

Endometrial Cancer

Neoadjuvant Chemotherapy

Cognitive Dysfunction

Ovarian Cancer

Frailty at Older Adults

Treatments

Other: data collection

Study type

Observational

Funder types

Other

Identifiers

NCT07220512

ONC-GYN-2401 (Other Identifier)

IRB00129176

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

35 estimated patients

Sex

Female

Ages

55+ years old

Volunteers

No Healthy Volunteers

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.