Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT06497569
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2024-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'To reduce risk of bias, only assessors unaware of randomization status will be used to assess study outcomes.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2024-07-05', 'studyFirstSubmitQcDate': '2024-07-05', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment Rate- Feasibility', 'timeFrame': 'Up to 48 Months', 'description': 'The Study will be deemed feasible ≥ 50% of eligible patients are enrolled.'}, {'measure': 'Retention Rate- Feasibility', 'timeFrame': 'Up to 90 Days', 'description': 'The Study will be deemed feasible if ≥ 70% of participants enrolled at baseline are retained at the end of the intervention period.'}, {'measure': 'Patient-reported outcome completion-Feasibility', 'timeFrame': 'Up to 6 Months', 'description': 'The Study will be deemed feasible if ≥ 70% of participants enrolled submit 4 of the 6 study assessments.'}, {'measure': 'Food Log Data Collection-Feasibility', 'timeFrame': 'Up to 6 Months', 'description': 'The study will be deemed feasible if ≥ 70% of participants enrolled log food for greater than 80% of study days (72 out of 90).'}, {'measure': 'Adherence to Dietitian Visits- Feasibility', 'timeFrame': 'Up to 6 Months', 'description': 'The Study will be deemed feasible if ≥ 70% of participants enrolled attend 4 out of 6 dietitian visits.'}, {'measure': 'Fidelity to Study Protocol- Feasibility', 'timeFrame': 'Up to 6 Months', 'description': 'The Study will be deemed feasible if 20% of randomly audited dietitian visits have documented PG-SGA and calorie and protein goals'}, {'measure': 'Patient Rating of MyPlate app-Feasibility', 'timeFrame': 'Up to 6 Months', 'description': 'The Study will be deemed feasible if ≥ 70% of participants rate the MyPlate app as east-to use utilizing a validated usability scale (score ≥ 60).'}, {'measure': 'Participant Satisfaction- Acceptability', 'timeFrame': 'Up to 6 Months', 'description': 'Patient satisfaction with the intervention will be deemed acceptable if ≥ 70% of participants rate the intervention as satisfactory utilizing a validated 4 item scale (score range 0-20).\n\nA cutoff score of ≥ 12 based on prior studies to define intervention acceptability will be used.'}], 'secondaryOutcomes': [{'measure': 'Malnutrition -Nutritional Status', 'timeFrame': 'Baseline, 3 Months, 6 Months', 'description': 'Nutritional status will be measured using the Patient-Generated Subjective Global Assessment (PG-SGA) Short Form (score range: 0-35) and categorized based on a prior validation study (0-1 well nourished, 2-8 at-risk, ≥ 9 severely malnourished).'}, {'measure': 'Malnutrition-Significant weight loss', 'timeFrame': 'Baseline, 3 Months, 6 Months', 'description': 'Significant weight loss is defined as \\>5% and \\>10% of body weight. This will be calculated based on weight obtained during clinic visits.'}, {'measure': 'Malnutrition - Low BMI', 'timeFrame': 'Baseline, 3 Months, 6 Months', 'description': 'Low BMI will be defined as \\<20kg/m² for individuals \\<70 years old and \\<22kg/m2 for individuals ≥70 years old.\n\nThis will be calculated based on weight and height measurements from clinic visits.'}, {'measure': 'Malnutrition - Low Skeletal Muscle Mass', 'timeFrame': 'Baseline, 3 Months, 6 Months', 'description': 'Low muscle mass will be estimated by calculating skeletal muscle index (SMI) from routinely collected CT scans at baseline, 3 months and 6 months (CT scans are conducted every 3 months). Low muscle mass will be defined as SMI ≤38.5 cm2 /m2 for females and SMI ≤52.4 cm2 /m2 for males.'}, {'measure': 'Quality of Life Questionnaires', 'timeFrame': 'Baseline, 3 Months, 6 Months', 'description': "Quality of Life will be measured using the Functional Assessment of Cancer Therapy - General (FACT-G) Scale and the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) subscales.\n\n(FACT-G) and (FAACT) Questionnaires include questions about the participant's physical, social, emotional and functional well-being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher score indicates a better quality of life."}, {'measure': 'Treatment Adherence', 'timeFrame': 'Baseline, 3 Months, 6 Months', 'description': 'Treatment Adherence will be measured by obtaining scheduling and electronic health record (EHR) data to estimate adherence to chemotherapy and/or radiation therapy.\n\nComparison of will be made of planned vs. received chemotherapy and/or radiation regimens to define 1) treatment delay (yes/no); 2) dose reduction (yes/no); and 3) treatment discontinuation (yes/no). We will also document receipt of surgery (yes/no).'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to 48 Months', 'description': 'Progression Free Survival (PFS) status will be obtained from the cancer center registry to estimate overall survival (the time from random assignment to death from any cause) and progression-free survival (the time from random assignment to disease progression or death from any cause).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nutrition Support'], 'conditions': ['GastroEsophageal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.moffitt.org/clinical-trials-research/clinical-trials/', 'label': 'Moffitt Cancer Center Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be 18 years of age or older\n* Participants must have locally advanced or metastatic gastroesophageal cancer (GEC)\n* Participants must plan to initiate chemotherapy and/or radiation therapy with a plan to have surgery or definitive treatment follow up at Moffitt\n* Participants must be able to speak and read Spanish and/or English\n* Participants must be able to provide informed consent\n\nExclusion Criteria:\n\n* Participants have a documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g. severe dementia)\n* Use of feeding tubes at the time of study enrollment'}, 'identificationModule': {'nctId': 'NCT06497569', 'briefTitle': 'Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer (STRONG-GEC)', 'orgStudyIdInfo': {'id': 'MCC-23230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STRONG Intervention', 'description': 'Participants will receive an initial consultation and biweekly follow-up visits with a study dietitian for 90 days.\n\nDuring the follow-up visits, the study dietitian will review the dietary plan and goals, review the dietary food log, and discuss any challenges with dietary intake and recommendations for improving dietary intake.\n\nParticipants will keep a daily diary of food intake with a Fitbit smartphone app and a Fitbit wearable device for 90 days, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention.', 'interventionNames': ['Behavioral: Dietitian Consultation', 'Behavioral: Survey', 'Behavioral: Fitbit Data Collection', 'Behavioral: Social Determinants of Health Survey (SDOH)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care Intervention', 'description': "Participants will be referred to a study dietitian based on their standard-care clinician's discretion, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention.", 'interventionNames': ['Behavioral: Dietitian Consultation', 'Behavioral: Survey', 'Behavioral: Referral to Dietitian']}], 'interventions': [{'name': 'Dietitian Consultation', 'type': 'BEHAVIORAL', 'description': 'Participants will meet with a dietitian who will provide individualized nutrition counseling and dietary goals for calorie and protein intake.\n\nBi-weekly, 30-minute dietitian telehealth visits will be conducted via ZOOM videoconferencing at the pre-intervention baseline visit, monthly during the intervention period (up to 90 days) and at the 4 and 6 month timepoints post-intervention.', 'armGroupLabels': ['STRONG Intervention', 'Usual Care Intervention']}, {'name': 'Survey', 'type': 'BEHAVIORAL', 'description': 'Surveys will be conducted using the PG-SGA short form19-21 and a brief symptom assessment tool that captures additional nutrition-impact symptoms not captured by the PG-SGA (e.g., swallowing difficulty) measured by the FACT Esophageal and Gastric Cancer scales and the FAACT anorexia/cachexia scales 22,23 through REDCap.\n\nSurveys are completed at the pre-intervention baseline visit and monthly during the intervention period prior to the dietitian visits (up to 90 days), and at the 4 and 6 month timepoints post-intervention.', 'armGroupLabels': ['STRONG Intervention', 'Usual Care Intervention']}, {'name': 'Fitbit Data Collection', 'type': 'BEHAVIORAL', 'description': 'Participants will log food intake while sharing their data with a dietitian during the 30-minute dietitian telehealth visits at the pre-intervention baseline visit, monthly during the intervention period (up to 90 days) and at the 4 and 6 month timepoints post-intervention.', 'armGroupLabels': ['STRONG Intervention']}, {'name': 'Referral to Dietitian', 'type': 'BEHAVIORAL', 'description': 'Usual Care condition referral to a dietitian based on physician discretion.', 'armGroupLabels': ['Usual Care Intervention']}, {'name': 'Social Determinants of Health Survey (SDOH)', 'type': 'BEHAVIORAL', 'description': 'Participants will complete a SDOH Survey that captures individual-level factors (insurance type, preferred language, educational attainment, annual household income, digital health literacy, financial toxicity, and self-reported barriers to care \\[e.g., transportation\\]) and structural-level factors (neighborhood disadvantage, rural residence).\n\nDigital health literacy will be measured using the validated eHEALS scale, an 8-item measure assessing confidence with finding, evaluating, and applying electronic information to inform health decision-making (score ≤ 30 indicates low literacy).', 'armGroupLabels': ['STRONG Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emma Hume', 'role': 'CONTACT', 'email': 'Emma.Hume@moffitt.org', 'phone': '813-745-6426'}, {'name': 'Amir Alishahi Tabriz, MD, phD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jose Pimiento, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kea Turner, PhD, MPH, MA', 'role': 'CONTACT', 'email': 'Kea.Turner@unc.edu', 'phone': '919-966-4432'}, {'name': 'Kea Turner, PhD, MPH, MA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UNC Lineberger Comprehensive Cancer Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'centralContacts': [{'name': 'Emma Hume', 'role': 'CONTACT', 'email': 'Emma.Hume@moffitt.org', 'phone': '813-745-6426'}], 'overallOfficials': [{'name': 'Amir Alishahi Tabriz, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}, {'name': 'Jose Pimiento, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}