Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-04-12 @ 3:01 PM
Study NCT ID:
NCT06001268
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2023-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Support Through Remote Observation and Nutrition Guidance Program (STRONG-PCS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, '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': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2023-08-14', 'studyFirstSubmitQcDate': '2023-08-18', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment Rate - Feasibility', 'timeFrame': 'Up to 48 months', 'description': 'The study will be deemed feasible if ≥ 50% of eligible participants are enrolled.'}, {'measure': 'Retention Rate - Feasibility', 'timeFrame': 'at 8 weeks', 'description': 'The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks.'}, {'measure': 'Data Collection - Feasibility', 'timeFrame': 'at 8 weeks', 'description': 'The study will be deemed feasible if ≥ 70% of participants log food for greater than 80% of study days.'}, {'measure': 'Participant Satisfaction - Acceptability', 'timeFrame': 'at 8 weeks', 'description': 'The study will be deemed acceptable if ≥ 70% of participants rate the overall intervention as satisfactory using a validated 4-item scale (score range 0-20, score \\>/= 12).'}, {'measure': 'Participant Rating on Ease of Use the Mobile Application - Usability', 'timeFrame': 'at 8 weeks', 'description': 'The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake using a validated 10-item scale (score range from 0-100, score of \\>/=60).'}], 'secondaryOutcomes': [{'measure': 'Malnutrition-Significant weight loss', 'timeFrame': '90 days', 'description': 'Significant weight loss is defined as \\>5% and \\>10% of body weight at 30, 60, and 90 days after discharge. This will be calculated based on weight obtained during clinic visits.'}, {'measure': 'Malnutrition - Low BMI', 'timeFrame': 'at Baseline, 30, 60 and 90 days', 'description': 'Low BMI will be defined as \\<20kg/m² for individuals \\<70 years old and \\<22kg/m2 for individuals ≥70 years old. This will be calculated based on weight and height measurements from clinic visits.'}, {'measure': 'Malnutrition - Low Skeletal Muscle Mass', 'timeFrame': 'At baseline, 30, 60 and 90 days', 'description': 'Low muscle mass will be estimated by calculating skeletal muscle index (SMI) from routinely collected CT scans at baseline and 90 days after discharge (CT scans are conducted every 3 months). Low muscle mass will be defined as SMI ≤38.9 cm2 /m2 for females and SMI ≤55.4 cm2 /m2 for males.'}, {'measure': 'Quality of Life', 'timeFrame': 'at Baseline, 4, 8 and 12 weeks', 'description': "Quality of Life will be measured using the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire includes 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': 'Hospital Readmissions', 'timeFrame': '30, 60 and 90 days post-hospital discharge', 'description': 'Hospital readmissions will be measured using a self-reported survey item to determine whether the patient was admitted to the index hospital or another hospital after hospital discharge.'}, {'measure': 'Malnutrition -Nutritional Status', 'timeFrame': 'at Baseline, 30, 60 and 90 days', '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nutrition Support'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.moffitt.org/clinical-trials-research/clinical-trials/', 'label': 'Moffitt Cancer Center Clinical Trial Search'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the feasibility and participant satisfaction with the Support through Remote Observation and Nutrition Guidance program. The program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are undergoing surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old\n* Diagnosis of pancreatic cancer\n* Completed open pancreatic surgery (e.g., Whipple, distal/subtotal pancreatectomy, total pancreatectomy) for treatment at Moffitt Cancer Center\n* Discharged on an oral diet\n* Able to speak and read English or Spanish\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Determined to be ineligible for surgery during evaluation (e.g., cancer metastasis)'}, 'identificationModule': {'nctId': 'NCT06001268', 'acronym': 'STRONG-PCS', 'briefTitle': 'Support Through Remote Observation and Nutrition Guidance Program (STRONG-PCS)', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'Support Through Remote Observation and Nutrition Guidance Program for Individuals With Pancreatic Cancer Undergoing Surgery (STRONG-PCS)', 'orgStudyIdInfo': {'id': 'MCC-22476'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STRONG-PCS Intervention', 'description': 'Participants will receive an initial in-person consultation with a dietician within 2 weeks of hospital discharge. Then participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician.', 'interventionNames': ['Behavioral: Fitbit Data Collection', 'Behavioral: Nutrition Counseling', 'Behavioral: Survey']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Participants will be referred for nutrition counseling from a dietitian based on clinical discretion.', 'interventionNames': ['Behavioral: Nutrition Counseling', 'Behavioral: Survey']}], 'interventions': [{'name': 'Fitbit Data Collection', 'type': 'BEHAVIORAL', 'description': 'Participants will log food intake while sharing their data with a dietician in real time for 12 weeks', 'armGroupLabels': ['STRONG-PCS Intervention']}, {'name': 'Nutrition Counseling', 'type': 'BEHAVIORAL', 'description': 'Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person.', 'armGroupLabels': ['STRONG-PCS Intervention', 'Usual Care']}, {'name': 'Survey', 'type': 'BEHAVIORAL', 'description': "Participants will take a survey at baseline and weeks 4,8,\\& 12. (FACT-G) Questionnaire includes questions about 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 total score indicates better quality of life.", 'armGroupLabels': ['STRONG-PCS Intervention', 'Usual Care']}]}, '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': 'Kea L Turner, PhD, MPH, MA', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pamela J Hodul, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Amir Alishahi Tabriz, MD, PhD, MPH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Brian D Gonzalez, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nate H Parker, MPH, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Laurence R Gore, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'centralContacts': [{'name': 'Emma Hume', 'role': 'CONTACT', 'email': 'emma.hume@moffitt.org', 'phone': '813-745-6426'}, {'name': 'Kea L Turner, PhD', 'role': 'CONTACT', 'email': 'Kea.Turner@moffitt.org', 'phone': '813-745-5213'}], 'overallOfficials': [{'name': 'Kea Turner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}, {'name': 'Pamela J Hodul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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'}}}}