The BHFS Study (Better, Harder, Faster, Stronger): Does Neoadjuvant Chemotherapy Improve Fitness for Surgery?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change in electronic frailty index (eFI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: data collection (Other)
结局指标
主要结局
Change in electronic frailty index (eFI)
时间窗: 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.
次要结局
- Change in proportion of participants in the fit/pre-frail (eFI score ≤ 0.21) versus frail category (eFi score > 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.)
- Prevalence of cognitive dysfunction(Before NACT - At visit 1, no later than 60 days after consent)
- Prevalence of patient-reported cognitive dysfunction(Before NACT - At visit 1, no later than 60 days after consent)
- Changes in cognitive function as measured by MoCA(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(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(Before NACT - At visit 1, no later than 60 days after consent)