Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT05825469
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-15
First Post:
2023-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development and Testing of Nutritional Algorithms (NACHO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-27', 'size': 270480, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-27T08:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2023-04-21', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nutrition Algorithm', 'timeFrame': '12 months', 'description': "Primary study endpoint is development of a nutrition algorithm using the Cancer Nutrition Consortium (CNC) study findings and iteratively refine through an expert Dana-Farber Cancer Institute dietary panel along with consultations from oncology clinicians as needed and feedback from a panel of 4-6 Patient and Family Advisory Council (PFAC) members. Specific to data analyses, chi square, fisher's exact tests, and linear regression will be used to evaluate characteristics associated with changes in taste and different food preferences over time. Findings will inform the development of the algorithms."}], 'secondaryOutcomes': [{'measure': 'Acceptability of Nutrition Algorithm for Cancer Health Outcomes (NACHO) Program', 'timeFrame': 'Up to 8 months', 'description': 'Assessed using the System Usability Scale (SUS), a 10-item instrument with scores that range from 0-100 with higher scores representing greater usability. Acceptability is defined as a SUS score of \\>70.'}, {'measure': 'Participant Satisfaction', 'timeFrame': 'Up to 8 months', 'description': 'Assessed using the Acceptability e-Scale (AES), a six-item scale that measures how easy, enjoyable, understandable, and helpful the intervention is. Total scores range from 6-30 with higher scores representing greater acceptability. Acceptability is defined as a AES score of \\>24.'}, {'measure': 'Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Age', 'timeFrame': 'Up to 12 months', 'description': 'Age group (i.e., 18-29, 30-39, 40-49, 50-59, 60-69, 70-79, 80+)'}, {'measure': 'Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Gender identity', 'timeFrame': 'Up to 12 months', 'description': 'Gender identity (i.e., female, male, other\\_\\_\\_\\_, prefer not to answer)'}, {'measure': 'Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Ethnicity', 'timeFrame': 'Up to 12 months', 'description': 'Ethnicity (i.e., Hispanic/Latinx / non-Hispanic/non-Latinx, prefer not to answer)'}, {'measure': 'Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Race', 'timeFrame': 'Up to 12 months', 'description': 'Race (i.e., Black, Caucasian, Asian, Native American, Pacific Islander, Alaska Native, multiracial, prefer not to answer)'}, {'measure': 'Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Position', 'timeFrame': 'Up to 12 months', 'description': 'Position / role and years in position (non-patient panel members only) (fill in)'}, {'measure': 'Characteristics of the cohort of 100 patients (Aim 3) - Age', 'timeFrame': 'Up to 12 months', 'description': 'Age group (i.e., 18-29, 30-39, 40-49, 50-59, 60-69, 70-79, 80+)'}, {'measure': 'Characteristics of the cohort of 100 patients (Aim 3) - Gender identity', 'timeFrame': 'Up to 12 months', 'description': 'Gender identity (i.e., female, male, other\\_\\_\\_\\_, prefer not to answer)'}, {'measure': 'Characteristics of the cohort of 100 patients (Aim 3) - ethnicity', 'timeFrame': 'Up to 12 months', 'description': 'Ethnicity (i.e., Hispanic/Latinx / non-Hispanic/non-Latinx, prefer not to answer)'}, {'measure': 'Characteristics of the cohort of 100 patients (Aim 3) - race', 'timeFrame': 'Up to 12 months', 'description': 'Race (i.e., Black, Caucasian, Asian, Native American, Pacific Islander, Alaska Native, multiracial, prefer not to answer)'}, {'measure': 'Characteristics of the cohort of 100 patients (Aim 3) - BMI', 'timeFrame': 'Up to 12 months', 'description': 'Body mass index will will be calculated from weight in pounds and height in inches using the formula: weight (lb) / \\[height (in)\\]squared x 703'}, {'measure': 'Characteristics of the cohort of 100 patients (Aim 3) - Comorbidities', 'timeFrame': 'Up to 12 months', 'description': 'Comorbidities: Number of comorbidities (e.g., heart disease, diabetes) will be abstracted from electronic health records'}, {'measure': 'Global Health', 'timeFrame': 'Up to 12 months', 'description': 'PROMIS-10 Global Health Questionnaire v.1.2 is an NIH-developed, valid and reliable instrument that will be used to assess functional status and quality of life. Higher scores represent better health. Scores will be computed to identify global physical and mental health component scores. Participant patients will complete this assessment at baseline, 2 months, and 5 months (visits 1, 3, and 6, respectively). T-scores will be used in the analysis to identify characteristics associated with other participant patients at the same global health levels. Changes in T-scores over time will be compared with changes in BMI and associated with utilization of the nutrition algorithm.'}, {'measure': 'Symptom Questions', 'timeFrame': 'Up to 12 months', 'description': 'Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAETM) will be used to collect data on the occurrence, severity, and level of interference with daily activities for sleep quality (i.e., insomnia), pain, fatigue, and depression (i.e., anxiety, discouraged, sad) at baseline, 2 months, and 5 months (respectively visits 1, 3, and 6). Higher scores will indicate worse symptom experiences. T-scores will be used in the analysis to identify characteristics associated with other participant patients at the same global health levels. Changes in T-scores over time will be compared with changes in BMI and associated with utilization of the nutrition algorithm.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Poor Nutrition', 'Nutritional Deficiency', 'Quality of Life'], 'conditions': ['Nutrition Poor', 'Nutritional Deficiency', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'The goal of this research study is to develop a nutrition algorithm to optimize nutritional status and improve quality of life during for participants who are completing or have completed cancer treatment.\n\nThe name of the intervention used in this research study is:\n\nNutrition Algorithm for Cancer Health Outcomes (NACHO) (a technology-based platform that houses the algorithms for the person-centered nutrition program)', 'detailedDescription': 'This is a longitudinal, mixed-methods, pilot descriptive study to develop a nutrition algorithm for cancer patients based on the Cancer Nutrition Consortium (CNC) study findings and refined through a dietitian panel participants and from feedback from participants and Family Advisory Council (PFAC) members.\n\nResearch study procedures include screening for eligibility, interviews and/or focus groups, dietitian panel meetings, and surveys.\n\nParticipation in this study is expected to last about 12 months.\n\nIt is expected about 130 people will participate in this research study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for Dietitians/Oncology clinicians - Have worked with at least 3 patients at the study site who had nutritional challenges\n\nInclusion Criteria for Patient and Family Advisory Council (PFAC) participants\n\n* Current member of adult PFAC\n* \\> 18 years old\n\nInclusion Criteria for Patient participants\n\n* \\> 18 years old\n* Able to speak and read English\n* Completed primary treatment (aim 2b) or actively undergoing treatment (aim 2b and aim 3, exploratory)\n* Access to a device (e.g., computer, tablet, smartphone) through which they can receive and engage with a REDCap link\n\nExclusion Criteria for Patient Participants\n\n• Provider does not recommend'}, 'identificationModule': {'nctId': 'NCT05825469', 'briefTitle': 'Development and Testing of Nutritional Algorithms (NACHO)', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Development and Usability Testing of Nutrition Algorithms for Cancer Health Outcomes (NACHO) and Quality of Life During Cancer Treatment', 'orgStudyIdInfo': {'id': '22-637'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutrition Algorithm (NACHO)', 'description': 'Study procedures will be conducted as follows:\n\n* Development of nutrition algorithm by dietitian panel participants with oncology clinician consultation via convened group meetings.\n* Refinement of draft algorithms through feedback from participants and Family Advisory Council (PFAC) members.\n* Baseline questionnaires for participants.\n* Semi-structured interviews and/or focus groups with participants to evaluate algorithm usability and acceptability.\n* Participant questionnaires.', 'interventionNames': ['Behavioral: Nutrition Algorithm']}], 'interventions': [{'name': 'Nutrition Algorithm', 'type': 'BEHAVIORAL', 'otherNames': ['Nutrition Algorithm for Cancer Health Outcomes (NACHO) Program'], 'description': 'A technology-based platform for a person-centered nutrition program, providing suggested foods and recipes from dietitians.', 'armGroupLabels': ['Nutrition Algorithm (NACHO)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Marilyn Hammer, MD', 'role': 'CONTACT', 'email': 'MarilynJ_Hammer@dfci.harvard.edu', 'phone': '617-632-1909'}], 'overallOfficials': [{'name': 'Marilyn Hammer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data can be shared no earlier than 1 year following the date of publication', 'ipdSharing': 'YES', 'description': 'The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \\[contact information for Sponsor Investigator or designee\\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Nutrition Consortium Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marilyn Hammer, PhD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}