Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-29 @ 4:17 AM
Study NCT ID:
NCT07220512
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2025-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Better, Harder, Faster, Stronger Study
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
The BHFS Study (Better, Harder, Faster, Stronger): Does Neoadjuvant Chemotherapy Improve Fitness for Surgery?
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ONC-GYN-2401 | OTHER | Atrium Health Wake Forest Baptist Comprehensive Cancer Center | View |