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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2025-10-13', 'studyFirstSubmitQcDate': '2025-10-22', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'Post-NACT - no later than 30 days after completion of the last cycle of NACT', 'description': 'Length of hospital stay'}, {'measure': 'Surgical complication', 'timeFrame': 'Post-NACT - no later than 30 days after completion of the last cycle of NACT', 'description': '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).'}, {'measure': 'Discharge disposition home vs. rehabilitation facility', 'timeFrame': 'Post-NACT - no later than 30 days after completion of the last cycle of NACT', 'description': 'A binary variable indicating discharge disposition: home (0) vs. rehabilitation facility (1).'}, {'measure': 'Screening rate', 'timeFrame': 'at screening', 'description': '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.'}, {'measure': 'Retention rate', 'timeFrame': 'Post-NACT - no later than 30 days after completion of the last cycle of NACT', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Change in electronic frailty index (eFI)', 'timeFrame': '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)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in proportion of participants in the fit/pre-frail (eFI score ≤ 0.21) versus frail category (eFi score > 0.21)', 'timeFrame': '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.', 'description': 'eFI scores are categorized into fit/pre-frail and frail category using the cut of point 0.21'}, {'measure': 'Prevalence of cognitive dysfunction', 'timeFrame': 'Before NACT - At visit 1, no later than 60 days after consent', 'description': 'A MoCA score of 25 or less is used to define cognitive dysfunction'}, {'measure': 'Prevalence of patient-reported cognitive dysfunction', 'timeFrame': 'Before NACT - At visit 1, no later than 60 days after consent', 'description': 'A FACT-Cog PCI score of less than 54 is used to define cognitive dysfunction'}, {'measure': 'Changes in cognitive function as measured by MoCA', 'timeFrame': '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', 'description': 'Changes in cognitive function are calculated based on changes in MoCA before and after NACT'}, {'measure': 'Changes in cognitive function as measured by FACT-Cog PCI', 'timeFrame': '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', 'description': 'Changes in cognitive function are calculated based on changes in FACT-Cog PCI score before and after NACT'}, {'measure': 'Prevalence of mood disorder', 'timeFrame': 'Before NACT - At visit 1, no later than 60 days after consent', 'description': 'Defined as a PHQ-2 score of 3 or greater'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Frailty', 'ovarian cancer', 'endometrial cancer', 'cognitive dysfunction', 'neoadjuvant chemotherapy'], 'conditions': ['Frailty at Older Adults', 'Ovarian Cancer', 'Endometrial Cancer', 'Cognitive Dysfunction', 'Neoadjuvant Chemotherapy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nChanges 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.\n\nParticipants with either ovarian/primary peritoneal/fallopian tube carcinoma or endometrial carcinoma will be approached for interest in participating in this study.\n\nPrior 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.\n\nAfter 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients 55 or older seen in clinic with either ovarian/primary peritoneal/fallopian tube carcinoma or endometrial carcinoma who are planned for NACT', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to understand and willingness to sign an IRB-approved informed consent.\n* Age \\> 55 years at the time of enrollment.\n* 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.\n* Planned for 3 or 4 cycles of NACT, with interval cytoreductive surgery planned thereafter.\n* Ability to read, understand, and write the English language.\n* As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n* History of brain metastases.\n* 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.\n* Use of anti-amyloid agents, cholinesterase inhibitors, or glutamate regulators at the time of enrollment.\n* Vision impairment that would impede completion of study assessments, per enrolling investigator.'}, 'identificationModule': {'nctId': 'NCT07220512', 'briefTitle': 'The Better, Harder, Faster, Stronger Study', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'The BHFS Study (Better, Harder, Faster, Stronger): Does Neoadjuvant Chemotherapy Improve Fitness for Surgery?', 'orgStudyIdInfo': {'id': 'IRB00129176'}, 'secondaryIdInfos': [{'id': 'ONC-GYN-2401', 'type': 'OTHER', 'domain': 'Atrium Health Wake Forest Baptist Comprehensive Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with ovarian or endometrial carcinoma with planned NACT.', 'description': 'Participants over 55 years old with either ovarian/primary peritoneal/fallopian tube carcinoma or endometrial carcinoma', 'interventionNames': ['Other: data collection']}], 'interventions': [{'name': 'data collection', 'type': 'OTHER', 'description': 'PROs, historical and longitudinal data collection and eFI calculation', 'armGroupLabels': ['Participants with ovarian or endometrial carcinoma with planned NACT.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sydney McEntire, RN', 'role': 'CONTACT', 'email': 'sydney.mcentire@advocatehealth.org', 'phone': '336-713-5879'}, {'name': 'Anna Kuan-Celarier, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wake Forest Baptist Comprehensive Cancer Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'centralContacts': [{'name': 'Sydney McEntire, RN', 'role': 'CONTACT', 'email': 'sydney.mcentire@advocatehealth.org', 'phone': '336-713-5879'}], 'overallOfficials': [{'name': 'Anna Kuan-Celarier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Atrium Health Wake Forest Baptist', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}