Clinical trial · Observational
The Better, Harder, Faster, Stronger Study
The BHFS Study (Better, Harder, Faster, Stronger): Does Neoadjuvant Chemotherapy Improve Fitness for Surgery?
NCT07220512CI-TRIAL-00118031recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Dysfunction | — | UNRESOLVED | — |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Frailty at Older Adults | — | UNRESOLVED | — |
| Neoadjuvant Chemotherapy | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| data collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants with ovarian or endometrial carcinoma with planned NACT.
- description
- Participants over 55 years old with either ovarian/primary peritoneal/fallopian tube carcinoma or endometrial carcinoma
- interventionNames
- Other: data collection
Primary outcomes (1)
- measure
- Change in electronic frailty index (eFI)
- timeFrame
- 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)
- description
- 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 (6)
- measure
- Change in proportion of participants in the fit/pre-frail (eFI score ≤ 0.21) versus frail category (eFi score > 0.21)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.