Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-03 @ 12:37 AM
Study NCT ID:
NCT06534918
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precise Oncology Interventions in Nutrition and Training (OnPoint)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009752', 'term': 'Nutritional Status'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 306}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Survivors Who Agree to Participate', 'timeFrame': 'Up to 8 Weeks', 'description': 'Percentage of survivors who agree to participate will be reported as ≥ 50%.'}, {'measure': 'Percentage of Interventions Sessions Completed', 'timeFrame': 'Up to 8 Weeks', 'description': 'Percentage of intervention sessions completed will be reported as ≥ 80%.'}, {'measure': 'Percentage of Participants Satisfied with the Intervention', 'timeFrame': 'Up to 8 Weeks', 'description': 'Report of 80% satisfaction will be determined as satisfaction with intervention components.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Prostate Cancer', 'Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if survivors of breast, prostate, or colorectal cancer who receive a personal referral to a targeted nutrition and exercise program will be able to eat a healthier diet and be more physically activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria - Healthcare Providers\n\n1. Provide full- or part-time care in an oncology clinical care setting at Sylvester Comprehensive Cancer Center\n2. Utilize the electronic medical record for patient documentation on a regular basis\n3. Willing to complete a 30-60-minute interview\n\nInclusion Criteria - Patients\n\n1. 18 years of age or older\n2. Any sex/gender\n3. Able to provide consent\n4. Able to read/understand English or Spanish\n5. Diagnosis of breast, prostate or colorectal cancer, 6 months post completion of primary treatment, with no evidence of primary disease\n6. Approval from treating oncologist, confirmed via email or in writing\n7. Fail to meet at least one of the American Cancer Society guidelines: engaging in \\>150 minutes of moderate-to-vigorous physical activity per week for the prior month or consuming at least 3 cups of vegetables and 2 cups of fruit per day over the past month.\n8. Internet access on a smart phone, tablet, or computer\n9. Agree to be randomly assigned to any study group\n\nExclusion Criteria:\n\n1. Less than 18 years of age\n2. Unable to provide consent\n3. Unable to read/understand English or Spanish\n4. Any contraindication for diet change or exercising as determined by physician\n5. Blank\n6. Engaging in \\>150 minutes of moderate to vigorous physical activity on average per week for the prior month\n7. Meeting the American Cancer Society diet recommendations (3 cups of vegetables or legumes, 2 cups of fruit, 2 serving whole grain per day, and limited red/processed meats, sugar-sweetened beverages, and highly processed foods) for the prior month\n8. History of dementia or major psychiatric disease which would interfere with study participation\n9. History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure\n10. Eastern Cooperative Oncology Group (ECOG) score of \\>2\n11. Severe lymphedema as determined by physician\n12. Receiving physical therapy treatment'}, 'identificationModule': {'nctId': 'NCT06534918', 'acronym': 'OnPoint', 'briefTitle': 'Precise Oncology Interventions in Nutrition and Training (OnPoint)', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Precise Oncology Interventions in Nutrition and Training (OnPoint)', 'orgStudyIdInfo': {'id': '20230533'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Complexity Group', 'description': 'Participants in this group will receive the low complexity intervention for up to eight (8) weeks.', 'interventionNames': ['Other: Fitbit', 'Behavioral: Nutrition and Physical Activity Prescription']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Complexity Group', 'description': 'Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks.', 'interventionNames': ['Other: Fitbit', 'Behavioral: Nutrition Course: Group Sessions', 'Behavioral: Physical Activity Program: Group Sessions', 'Behavioral: Nutrition and Physical Activity Prescription']}, {'type': 'EXPERIMENTAL', 'label': 'High Complexity Group', 'description': 'Participants in this group will receive the high complexity intervention for up to eight (8) weeks.', 'interventionNames': ['Other: Fitbit', 'Behavioral: Nutrition Course: One on One Sessions with Registered Dietitian', 'Behavioral: Physical Activity Program: One on One Sessions with an Exercise Physiologist', 'Behavioral: Nutrition and Physical Activity Prescription']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants randomized to this arm will receive routine care and will not receive any study materials until the end of the study at 24 weeks.'}], 'interventions': [{'name': 'Fitbit', 'type': 'OTHER', 'description': 'Participants will be provided with a Fitbit. Self-reported physical activity, location, vital sign and sleep stage information will be collected and monitored every day for up to eight (8) weeks. Data will be synced to the My Wellness Research Software Platform, resulting in a weekly text or phone call check-in, based on participants preference.', 'armGroupLabels': ['High Complexity Group', 'Low Complexity Group', 'Moderate Complexity Group']}, {'name': 'Nutrition Course: Group Sessions', 'type': 'BEHAVIORAL', 'description': 'The nutrition course will follow a combined asynchronous and synchronous approach. The asynchronous component will consist of a pre-recorded session covering educational nutrition content, which will be made available to participants for self-paced learning. This will be followed by a synchronous, 30-60 minute live group education class on nutrition information for cancer survivors, held once per week.', 'armGroupLabels': ['Moderate Complexity Group']}, {'name': 'Physical Activity Program: Group Sessions', 'type': 'BEHAVIORAL', 'description': 'The Physical Activity Program will be held virtually or in-person. This will be a 1-hour biweekly group education class on aerobic and resistance exercise recommendations for cancer survivors.', 'armGroupLabels': ['Moderate Complexity Group']}, {'name': 'Nutrition Course: One on One Sessions with Registered Dietitian', 'type': 'BEHAVIORAL', 'description': 'Participants will be referred to weekly one on one nutrition counseling sessions with a Registered Dietitian. The one on one sessions are anticipated to last 30-60 minutes, based on the needs of the individual.', 'armGroupLabels': ['High Complexity Group']}, {'name': 'Physical Activity Program: One on One Sessions with an Exercise Physiologist', 'type': 'BEHAVIORAL', 'description': 'Participants will be referred to weekly one on one exercise training sessions with an Exercise Physiologist. The one on one sessions are anticipated to last 30-60 minutes, based on the needs of the individual', 'armGroupLabels': ['High Complexity Group']}, {'name': 'Nutrition and Physical Activity Prescription', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a lifestyle medicine prescription pad, developed by the investigators, which serves as a checklist to assist participants in effectively monitoring their dietary habits and physical activity routines. Participants will also receive an 8-week text messages program which will direct participants to a webpage with nutrition and physical activity content.', 'armGroupLabels': ['High Complexity Group', 'Low Complexity Group', 'Moderate Complexity Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Grey Freylersythe, BS', 'role': 'CONTACT', 'email': 'g.freylersythe@med.miami.edu', 'phone': '305-243-9832'}, {'name': 'Tracy Crane, PhD, RDN', 'role': 'CONTACT', 'email': 'tecrane@med.miami.edu', 'phone': '(305) 243-8255'}, {'name': 'Tracy Crane, PhD, RDN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Grey Freylersythe, BS', 'role': 'CONTACT', 'email': 'g.freylersythe@med.miami.edu', 'phone': '305-243-9832'}, {'name': 'Tracy Crane, PhD, RDN', 'role': 'CONTACT', 'email': 'tecrane@med.miami.edu', 'phone': '305-243-8255'}], 'overallOfficials': [{'name': 'Tracy Crane, PhD, RDN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Applebaum Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Tracy E Crane, PhD, RDN', 'investigatorAffiliation': 'University of Miami'}}}}