Frailty at Older AdultsNCT07220512
The Better, Harder, Faster, Stronger Study
An observational study of Frailty at Older Adults and Ovarian Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Frailty at Older Adults, Ovarian Cancer, Endometrial Cancer
- What is being tested?
- data collection
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2025to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Sydney McEntire, RN, 336-713-5879, sydney.mcentire@advocatehealth.org
Anna Kuan-Celarier, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Frailty at Older Adults, Ovarian Cancer, Endometrial Cancer, Cognitive Dysfunction, Neoadjuvant Chemotherapy
- Being tested
- data collection
- Keywords
- Frailty, ovarian cancer, endometrial cancer, cognitive dysfunction, neoadjuvant chemotherapy
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Cognitive Dysfunction, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
PROs, historical and longitudinal data collection and eFI calculation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
eFI scores are categorized into fit/pre-frail and frail category using the cut of point 0.21
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Changes in cognitive function are calculated based on changes in FACT-Cog PCI score before and after NACT
Measured: 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
Defined as a PHQ-2 score of 3 or greater
Measured: Before NACT - At visit 1, no later than 60 days after consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start28 Jul 2025
- Primary completionNov 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty at Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Wake Forest Baptist
- Responsible party
- Sponsor
- Investigators
- Anna Kuan-Celarier, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220512
- Sponsor's protocol ID
- IRB00129176
- Other IDs
- ONC-GYN-2401
- Status last verified
- Jul 2026
- First submitted
- 13 Oct 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BHFS Study (Better, Harder, Faster, Stronger): Does Neoadjuvant Chemotherapy Improve Fitness for Surgery?
- ClinicalTrials.gov ID
- NCT07220512
- Acronym / sponsor ID
- IRB00129176
- Conditions
- Frailty at Older Adults, Ovarian Cancer, Endometrial Cancer, Cognitive Dysfunction, Neoadjuvant Chemotherapy
- Keywords
- Frailty, ovarian cancer, endometrial cancer, cognitive dysfunction, neoadjuvant chemotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Wake Forest Baptist
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 24 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with ovarian or endometrial carcinoma with planned NACT. | – | Other: data collectionParticipants over 55 years old with either ovarian/primary peritoneal/fallopian tube carcinoma or endometrial carcinoma |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectionPROs, historical and longitudinal data collection and eFI calculation | Other | Participants with ovarian or endometrial carcinoma with planned NACT. |
Primary outcome
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.
6 secondary outcomes
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.
Prevalence of cognitive dysfunction
Time frame: 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
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 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
Prevalence of mood disorder
Time frame: Before NACT - At visit 1, no later than 60 days after consent
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Kuan-Celarier, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty at Older Adults and Ovarian Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sydney McEntire, RN (336-713-5879, sydney.mcentire@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.