The Better, Harder, Faster, Stronger Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: data collection.
- Who it may be relevant to
- Registry conditions: Frailty at Older Adults, Ovarian Cancer, Endometrial Cancer, Cognitive Dysfunction. Basic parameters: from 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The BHFS Study (Better, Harder, Faster, Stronger): Does Neoadjuvant Chemotherapy Improve Fitness for Surgery?
Overview
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.
Interventions
- Other data collection
PROs, historical and longitudinal data collection and eFI calculation
Primary outcome measures
- Change in electronic frailty index (eFI) [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)]
Secondary outcome measures (6)
- Change in proportion of participants in the fit/pre-frail (eFI score ≤ 0.21) versus frail category (eFi score > 0.21) [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.]
- Prevalence of cognitive dysfunction [Time frame: Before NACT - At visit 1, no later than 60 days after consent]
- Prevalence of patient-reported cognitive dysfunction [Time frame: Before NACT - At visit 1, no later than 60 days after consent]
- Changes in cognitive function as measured by MoCA [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 as measured by FACT-Cog PCI [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]
- Prevalence of mood disorder [Time frame: Before NACT - At visit 1, no later than 60 days after consent]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem
Identifiers
NCT: NCT07220512 · IRB00129176 · ONC-GYN-2401