Trials / Recruiting
RecruitingNCT07220512
The Better, Harder, Faster, Stronger Study
The BHFS Study (Better, Harder, Faster, Stronger): Does Neoadjuvant Chemotherapy Improve Fitness for Surgery?
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 35 (estimated)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- Female
- Age
- 55 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | data collection | PROs, historical and longitudinal data collection and eFI calculation |
Timeline
- Start date
- 2025-07-28
- Primary completion
- 2026-11-01
- Completion
- 2027-05-01
- First posted
- 2025-10-24
- Last updated
- 2025-10-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07220512. Inclusion in this directory is not an endorsement.