Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
Location status: Recruiting
Location contact
Anna Kuan-Celarier, MD
PRINCIPAL_INVESTIGATOR
Sydney McEntire, RN
CONTACT
NCT Number: NCT07220512
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.
Interested in participating?
Request Info55 year and older
Female
Observational
Winston-Salem, North Carolina, 27157, United States
Location status: Recruiting
Anna Kuan-Celarier, MD
PRINCIPAL_INVESTIGATOR
Sydney McEntire, RN
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PROs, historical and longitudinal data collection and eFI calculation
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.
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
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
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
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
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
Time frame: Before NACT - At visit 1, no later than 60 days after consent
Defined as a PHQ-2 score of 3 or greater
Time frame: Post-NACT - no later than 30 days after completion of the last cycle of NACT
Length of hospital stay
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).
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).
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.
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.
Contact information is provided by the study sponsor or research team.
Wake Forest University Health Sciences
Other
The BHFS Study (Better, Harder, Faster, Stronger): Does Neoadjuvant Chemotherapy Improve Fitness for Surgery?
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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