The Better, Harder, Faster, Stronger Study

October 22, 2025 updated by: Wake Forest University Health Sciences

The BHFS Study (Better, Harder, Faster, Stronger): Does Neoadjuvant Chemotherapy Improve Fitness for Surgery?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Anna Kuan-Celarier, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
PROs, historical and longitudinal data collection and eFI calculation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in electronic frailty index (eFI)
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)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in proportion of participants in the fit/pre-frail (eFI score ≤ 0.21) versus frail category (eFi score > 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.
eFI scores are categorized into fit/pre-frail and frail category using the cut of point 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
Time Frame: Before NACT - At visit 1, no later than 60 days after consent
A MoCA score of 25 or less is used to define cognitive dysfunction
Before NACT - At visit 1, no later than 60 days after consent
Prevalence of patient-reported cognitive dysfunction
Time Frame: Before NACT - At visit 1, no later than 60 days after consent
A FACT-Cog PCI score of less than 54 is used to define cognitive dysfunction
Before NACT - At visit 1, no later than 60 days after consent
Changes in cognitive function as measured by MoCA
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 are calculated based on changes in MoCA before and after NACT
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
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 are calculated based on changes in FACT-Cog PCI score before and after NACT
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
Prevalence of mood disorder
Time Frame: Before NACT - At visit 1, no later than 60 days after consent
Defined as a PHQ-2 score of 3 or greater
Before NACT - At visit 1, no later than 60 days after consent

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Post-NACT - no later than 30 days after completion of the last cycle of NACT
Length of hospital stay
Post-NACT - no later than 30 days after completion of the last cycle of NACT
Surgical complication
Time Frame: Post-NACT - no later than 30 days after completion of the last cycle of NACT
Surgical complication is coded as 0 if no complications occurred, and 1 if any of the complications listed in the NSQIP surgical complication list were present (https://cdn-links.lww.com/permalink/aa/d/aa_2020_05_21_freundlich_aa-d-19-02104r1_sdc1.pdf).
Post-NACT - no later than 30 days after completion of the last cycle of NACT
Discharge disposition home vs. rehabilitation facility
Time Frame: Post-NACT - no later than 30 days after completion of the last cycle of NACT
A binary variable indicating discharge disposition: home (0) vs. rehabilitation facility (1).
Post-NACT - no later than 30 days after completion of the last cycle of NACT
Screening rate
Time Frame: at screening
Screening rate is defined as the proportion of individuals who are potentially eligible, per EMR review, and are willing to be enrolled, out of the total number of participants approached for screening.
at screening
Retention rate
Time Frame: Post-NACT - no later than 30 days after completion of the last cycle of NACT
Retention rate will be defined as the proportion of enrolled participants who completed all required study procedures out of the total number of participants who were initially enrolled.
Post-NACT - no later than 30 days after completion of the last cycle of NACT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Atrium Health Wake Forest Baptist

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anna Kuan-Celarier, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00129176
  • ONC-GYN-2401 (Other Identifier: Atrium Health Wake Forest Baptist Comprehensive Cancer Center)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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