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| ID | Type | Description | Link |
|---|---|---|---|
| ONC-GYN-2401 | Other Identifier | Atrium Health Wake Forest Baptist Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| Atrium Health Wake Forest Baptist | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| data collection | Other | PROs, historical and longitudinal data collection and eFI calculation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Length of hospital stay | Post-NACT - no later than 30 days after completion of the last cycle of NACT |
| Surgical complication | 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). |
Inclusion Criteria:
Exclusion Criteria:
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Patients 55 or older seen in clinic with either ovarian/primary peritoneal/fallopian tube carcinoma or endometrial carcinoma who are planned for NACT
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sydney McEntire, RN | Contact | 336-713-5879 | sydney.mcentire@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Anna Kuan-Celarier, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| D060825 | Cognitive Dysfunction |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| Prevalence of cognitive dysfunction | A MoCA score of 25 or less is used to define cognitive dysfunction | 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 | 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 | 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 | 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 | Before NACT - At visit 1, no later than 60 days after consent |
| Post-NACT - no later than 30 days after completion of the last cycle of NACT |
| Discharge disposition home vs. rehabilitation facility | A binary variable indicating discharge disposition: home (0) vs. rehabilitation facility (1). | Post-NACT - no later than 30 days after completion of the last cycle of NACT |
| Screening rate | 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. | at screening |
| Retention rate | 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. | Post-NACT - no later than 30 days after completion of the last cycle of NACT |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |