Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-31 @ 4:30 PM
Study NCT ID:
NCT04365569
Status:
COMPLETED
Last Update Posted:
2025-09-29
First Post:
2020-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast 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'}]}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2020-04-24', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of life as measured by Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)', 'timeFrame': 'Baseline, 3 months and 6 months', 'description': 'Quality of life as measured by Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B), a 36-item self-report questionnaire to assess the quality of life as reported by breast cancer survivors with scores ranging from 0 to 123, and lower scores indicating better health.'}, {'measure': 'Quality of life as measured by Brief Pain Inventory (BPI)', 'timeFrame': 'Baseline, 3 months and 6 months', 'description': 'Quality of life as measured by Brief Pain Inventory (BPI), a 9-item self-administered questionnaire that can evaluate the effect of an individual\'s pain on their daily functioning. This is a 10-point scale with 0 being the best possible score, meaning "no pain", and 10 being the worst possible score, meaning "pain as bad as you can imagine"'}, {'measure': 'Quality of life as measured by Generalized Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Baseline, 3 months and 6 months', 'description': 'Quality of life as measured by Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report questionnaire measuring anxiety which uses a four-point rating scale (ranging from 0 to 3) asking how often in the last two weeks participants have experienced symptoms pertaining to feeling anxious, worried, difficulty relaxing, and irritability. Higher scores indicate higher distress. with a possible score range of 0 to 21 with higher scores indicating worse anxiety.'}, {'measure': 'Quality of life as measured by Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Baseline, 3 months and 6 months', 'description': 'Quality of life as measured by Patient Health Questionnaire-9 (PHQ-9), which objectifies degree of depression severity with a possible score range of 0 to 27 and higher scores indicating worse outcomes'}, {'measure': 'Quality of life as measured by NCCN Distress Thermometer', 'timeFrame': 'Baseline, 3 months and 6 months', 'description': 'Quality of life as measured by NCCN Distress Thermometer, which measures distress on a scale of 0 to 10, with higher scores indicating worse distress'}, {'measure': 'Factors associated with adherence to the program', 'timeFrame': 'At 6 months', 'description': 'Factors to be assessed include age, race, time since diagnosis, time since last chemotherapy, medical comorbidities and other lifestyle factors such as alcohol consumption and smoking'}], 'primaryOutcomes': [{'measure': 'Percent of participants achieving 10% weight loss', 'timeFrame': 'At baseline', 'description': 'Efficacy of intervention as assessed by percent of participants achieving 10% weight loss'}, {'measure': 'Percent of participants achieving 10% weight loss', 'timeFrame': 'At 3 months', 'description': 'Efficacy of intervention as assessed by percent of participants achieving 10% weight loss'}, {'measure': 'Percent of participants achieving 10% weight loss', 'timeFrame': 'At 6 months', 'description': 'Efficacy of intervention as assessed by percent of participants achieving 10% weight loss'}, {'measure': 'Compliance to the recommended dietary pattern', 'timeFrame': 'At 3 months', 'description': 'Assess compliance to the recommended dietary pattern, diet quality scores will be calculated by the RD after monthly telephone consults or in-person at 3 months and 6 months into the intervention. Each of the 3 elements will be scored from 0-3, resulting in a total score range from 0-9'}, {'measure': 'Compliance to physical activity goal', 'timeFrame': 'At 6 months', 'description': 'Percent of participants complying with proposed activity goal of 150 minutes of moderate intensity physical activity or 75 minutes of vigerous intensity physical activity (or a combination of both) per week over six months'}], 'secondaryOutcomes': [{'measure': 'Body fat percentage', 'timeFrame': 'Baseline', 'description': 'Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis'}, {'measure': 'Body fat percentage', 'timeFrame': '3 months', 'description': 'Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis'}, {'measure': 'Body fat percentage', 'timeFrame': '6 months', 'description': 'Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis'}, {'measure': 'Glycemic control as measured by HbA1c', 'timeFrame': 'At 3 months', 'description': 'Glycemic control as measured by HbA1c'}, {'measure': 'Glycemic control as measured by HbA1c', 'timeFrame': 'At 6 months', 'description': 'Glycemic control as measured by HbA1c'}, {'measure': 'Cholesterol', 'timeFrame': 'At 3 months', 'description': 'Effect of the intervention on lipid profile as measured by high density cholesterol levels'}, {'measure': 'Cholesterol', 'timeFrame': 'At 6 months', 'description': 'Effect of the intervention on lipid profile as measured by high density cholesterol levels'}, {'measure': 'Low density lipoprotein', 'timeFrame': 'At 3 months', 'description': 'Effect of the intervention on lipid profile as measured by low density lipoprotein levels'}, {'measure': 'Low density lipoprotein', 'timeFrame': 'At 6 months', 'description': 'Effect of the intervention on lipid profile as measured by low density lipoprotein levels'}, {'measure': 'high density lipoprotein', 'timeFrame': 'At 3 months', 'description': 'Effect of the intervention on lipid profile as measured by high density lipoprotein levels'}, {'measure': 'high density lipoprotein', 'timeFrame': 'At 6 months', 'description': 'Effect of the intervention on lipid profile as measured by high density lipoprotein levels'}, {'measure': 'Triglycerides', 'timeFrame': 'At 3 months', 'description': 'Effect of the intervention on lipid profile as measured by triglyceride levels'}, {'measure': 'Triglycerides', 'timeFrame': 'At 6 months', 'description': 'Effect of the intervention on lipid profile as measured by triglyceride levels'}, {'measure': 'Serum vitamin D', 'timeFrame': 'At 3 months', 'description': 'Effect of the intervention on serum vitamin D'}, {'measure': 'Serum vitamin D', 'timeFrame': 'At 6 months', 'description': 'Effect of the intervention on serum vitamin D'}, {'measure': 'Serum C-reactive protein (CRP)', 'timeFrame': 'At 3 months', 'description': 'Effect of the intervention on CRP'}, {'measure': 'Serum C-reactive protein (CRP)', 'timeFrame': 'At 6 months', 'description': 'Effect of the intervention on CRP'}, {'measure': 'Maximum oxygen uptake as measured by VO2 max', 'timeFrame': 'Baseline', 'description': 'Maximum oxygen uptake as measured by VO2 max'}, {'measure': 'Maximum oxygen uptake as measured by VO2 max', 'timeFrame': 'At 3 months', 'description': 'Maximum oxygen uptake as measured by VO2 max'}, {'measure': 'Maximum oxygen uptake as measured by VO2 max', 'timeFrame': 'At 6 months', 'description': 'Maximum oxygen uptake as measured by VO2 max'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'More than 65% of breast cancer survivors are overweight and less than one-third participate in recommended levels of physical exercise. Obese breast cancer survivors have been found to have greater than a two-fold increase in mortality compared to women with normal body mass index (BMI). The current standard for weight loss interventions involves in-person counseling. However, this incurs costs related to travel for counseling sessions, potentially limiting program participation, compliance and sustainability.This is a pilot study of an individualized in-person and telephone-based nutrition and exercise counseling program.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Breast cancer diagnosis (stage 0-III)\n* Body mass index of 25mg/k2 or greater\n* Actively being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center\n* Able and willing to participate in nutrition counseling at Maroone Cancer Center\n* Able (cleared by participant's primary oncologist) and willing to perform cardiopulmonary exercise testing\n* Participants must have the ability to understand and the willingness to sign a written informed consent document\n* Performance status 0 or 1 as per ECOG scale \\[see Appendix IV\\]\n\nExclusion Criteria:\n\n* Body mass index below 25kg/m2\n* No prior history of breast cancer\n* History of metastatic disease\n* Not being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center\n* Unable or unwilling to participate in nutrition counseling at Maroone Cancer Center\n* Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Participants actively undergoing chemotherapy, immunotherapy or radiation treatment. However, participants currently taking hormonal therapy, such as selective estrogen receptor modulators (SERMS), or aromatase inhibitors, may be included in the study."}, 'identificationModule': {'nctId': 'NCT04365569', 'briefTitle': 'Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program on Body Weight, Composition, Cardiovascular Function and Quality of Life in Breast Cancer Survivors', 'orgStudyIdInfo': {'id': 'CASE11119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individualized, nutrition and physical activity intervention', 'description': 'Initial in-person consult with a registered dietitian, with further in-person follow-ups and monthly telephone consults', 'interventionNames': ['Behavioral: Nutrition and physical activity counseling program']}], 'interventions': [{'name': 'Nutrition and physical activity counseling program', 'type': 'BEHAVIORAL', 'description': '6-month interventional, counseling program based on nutrition and physical activity consisting of:\n\n1\\. Nutritional counseling by a Registered Dietitian (RD) 2) Implementation of an adequate physical activity program', 'armGroupLabels': ['Individualized, nutrition and physical activity intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}], 'overallOfficials': [{'name': 'Elizabeth Stone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland Clinic, Case Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'Will share IPD with other researchers within the same institution, but not outside the institution'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}