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NCT Number: NCT07220512

The Better, Harder, Faster, Stronger Study

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

PROs, historical and longitudinal data collection and eFI calculation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Other outcomes

  1. 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

  2. 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).

  3. 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).

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sydney McEntire, RN

CONTACT

[email protected]

336-713-5879

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Atrium Health Wake Forest Baptist

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 24, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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