Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2026-01-02 @ 12:32 PM
Study NCT ID:
NCT06078761
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2023-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Eating and Active Lifestyle (HEAL): Breast Cancer Program Outcomes
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': 'D014945', 'term': 'Wound Healing'}], 'ancestors': [{'id': 'D012038', 'term': 'Regeneration'}, {'id': 'D001686', 'term': 'Biological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2023-09-27', 'studyFirstSubmitQcDate': '2023-10-05', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Stress Scale', 'timeFrame': 'Baseline, Week 8, 3-month follow up, 6-month follow up', 'description': 'PSS-10 is a ten item questionnaire covering the last month using 5 point Likert scale with 0 = Never, 1 = Almost never, 2 = Sometimes, 3 = Fairly often, 4 = Very often.'}], 'secondaryOutcomes': [{'measure': 'mini-Eating Assessment Tool (mini-EAT)', 'timeFrame': 'Baseline, Week 8, 3-month follow up, 6-month follow up', 'description': 'mini-EAT is a 9-item validated brief dietary screener where participants indicate how often they eat food groups with 9 response options: I do not eat it at all, Less than 1 serving per week, 1-2 servings per week, 3-4 servings per week, 5-6 servings per week, 1 serving per day, 2-3 servings per day, 4-5 servings per day, 6 or more servings per day'}, {'measure': 'Godin-Shephard Leisure-Time Physical Activity Questionnaire', 'timeFrame': 'Baseline, Week 8, 3-month follow up, 6-month follow up', 'description': 'Godin-Shephard Leisure-Time Physical Activity Questionnaire includes 3 categories that participants indicate number of times in a week they participate'}, {'measure': 'General Self-Efficacy Scale', 'timeFrame': 'Baseline, Week 8, 3-month follow up, 6-month follow up', 'description': 'The GSE includes 10 items with response categories: 1 = not at all true, 2 = hardly true, 3 = moderately true and 4 = exactly true'}, {'measure': 'Generalized Anxiety Disorder - 2 item scale', 'timeFrame': 'Baseline, Week 8, 3-month follow up, 6-month follow up', 'description': 'The GAD-2 is a 2-item scale about the last 2 weeks with response categories: 0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day'}, {'measure': 'Patient Health Questionnaire - 2 item', 'timeFrame': 'Baseline, Week 8, 3-month follow up, 6-month follow up', 'description': 'The PHQ-2 is a 2-item scale about the last 2 weeks with response categories: 0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day'}, {'measure': 'Functional Assessment of Cancer Therapy - General - 7-item version', 'timeFrame': 'Baseline, Week 8, 3-month follow up, 6-month follow up', 'description': 'The FACT-G7 is a 7 item scale about the last 7 days with response categories: 0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much'}, {'measure': 'Weight', 'timeFrame': 'Baseline, Week 8, 3-month follow up, 6-month follow up', 'description': 'Weight in kilograms'}, {'measure': 'Body Mass Index', 'timeFrame': 'Baseline, Week 8, 3-month follow up, 6-month follow up', 'description': 'Body Mass Index (BMI)'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline, Week 8, 3-month follow up, 6-month follow up', 'description': 'Blood pressure both systolic and diastolic'}, {'measure': 'Lipid panel', 'timeFrame': 'Baseline, Week 8, 3-month follow up, 6-month follow up', 'description': 'Standard of care Lipid panel'}, {'measure': 'Comprehensive metabolic panel', 'timeFrame': 'Baseline, Week 8, 3-month follow up, 6-month follow up', 'description': 'Standard of care Comprehensive metabolic panel'}, {'measure': 'Hemoglobin A1C', 'timeFrame': 'Baseline, Week 8, 3-month follow up, 6-month follow up', 'description': 'Standard of care Hemoglobin A1C'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '6668417', 'type': 'BACKGROUND', 'citation': 'Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.'}, {'type': 'BACKGROUND', 'citation': '2. Godin, G. (2011). The Godin-Shephard Leisure-Time Physical Activity Questionnaire. The Health & Fitness Journal of Canada, 4(1), 18-22. https://doi.org/10.14288/hfjc.v4i1.82'}, {'pmid': '17339617', 'type': 'BACKGROUND', 'citation': 'Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.'}, {'pmid': '14583691', 'type': 'BACKGROUND', 'citation': 'Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.'}, {'pmid': '36583423', 'type': 'BACKGROUND', 'citation': 'Lara-Breitinger KM, Medina Inojosa JR, Li Z, Kunzova S, Lerman A, Kopecky SL, Lopez-Jimenez F. Validation of a Brief Dietary Questionnaire for Use in Clinical Practice: Mini-EAT (Eating Assessment Tool). J Am Heart Assoc. 2023 Jan 3;12(1):e025064. doi: 10.1161/JAHA.121.025064. Epub 2022 Dec 30.'}, {'pmid': '31184787', 'type': 'BACKGROUND', 'citation': 'Miller KD, Nogueira L, Mariotto AB, Rowland JH, Yabroff KR, Alfano CM, Jemal A, Kramer JL, Siegel RL. Cancer treatment and survivorship statistics, 2019. CA Cancer J Clin. 2019 Sep;69(5):363-385. doi: 10.3322/caac.21565. Epub 2019 Jun 11.'}, {'pmid': '32922233', 'type': 'BACKGROUND', 'citation': 'Orman A, Johnson DL, Comander A, Brockton N. Breast Cancer: A Lifestyle Medicine Approach. Am J Lifestyle Med. 2020 Apr 26;14(5):483-494. doi: 10.1177/1559827620913263. eCollection 2020 Sep-Oct.'}, {'pmid': '30202290', 'type': 'BACKGROUND', 'citation': 'Patel Saxena S. Leveraging Time With Lifestyle-Based Group Visits. Am J Lifestyle Med. 2016 Jun 23;10(5):330-337. doi: 10.1177/1559827616638018. eCollection 2016 Sep-Oct.'}, {'type': 'BACKGROUND', 'citation': "9. Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy Scale. J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs, 35, 37."}, {'pmid': '23136235', 'type': 'BACKGROUND', 'citation': 'Yanez B, Pearman T, Lis CG, Beaumont JL, Cella D. The FACT-G7: a rapid version of the functional assessment of cancer therapy-general (FACT-G) for monitoring symptoms and concerns in oncology practice and research. Ann Oncol. 2013 Apr;24(4):1073-8. doi: 10.1093/annonc/mds539. Epub 2012 Nov 7.'}]}, 'descriptionModule': {'briefSummary': "The goal of this single-group prospective study is to examine the impact of the Healthy Eating and Active Lifestyle (HEAL) Breast Cancer program on participants' perceived stress, biometrics, basic labs, lifestyle behaviors, self-efficacy, mental health, and quality of life.\n\nParticipants will participate in an 8-week program of 90-minute virtual sessions each week to decrease risk of cancer recurrence. Program participants can choose to participate in the research study which will include data collection (surveys, biometrics, basic labs). The data collection will occur at four timepoints - baseline prior to program start, post-program, 3 month follow-up, and 6 month follow-up.", 'detailedDescription': 'The study will include 45 subjects recruited from AdventHealth Medical Group in the HEAL Breast Cancer Program that consent to participate in the research study. The research study will include data collection along with the program participation. Patients who decline participation in the research study are able to participate in the HEAL Breast Cancer Program. The program sessions will be conducted virtually via Zoom by Dr. Amber Orman, a breast cancer physician board certified in radiation oncology and lifestyle medicine. There are eight program sessions, one per week, each lasting 90-minutes. The survey package includes nine questionnaires and is expected to take 60 minutes to complete.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer survivors recruited from the AdventHealth Medical Group that were referred to attend the Healthy Eating and Active Lifestyle Breast Cancer Program.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult ≥ 18 years old\n2. Diagnosis of breast cancer\n3. Enrolled in the HEAL: Breast Cancer Program\n4. Able to speak, read, and understand English fluently\n5. Willing and able to provide informed consent\n6. Willing and able to comply with all study procedures and requirements for the duration of the study\n\nExclusion Criteria:\n\n1. Not willing or able to provide informed consent\n2. Not willing or able to comply with all study procedures and requirements for the duration of the study'}, 'identificationModule': {'nctId': 'NCT06078761', 'acronym': 'HEAL BC', 'briefTitle': 'Healthy Eating and Active Lifestyle (HEAL): Breast Cancer Program Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'A Prospective Study of the Healthy Eating and Active Lifestyle (HEAL): Breast Cancer Program on Survivorship Outcomes', 'orgStudyIdInfo': {'id': '2056943'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Healthy Eating Active Lifestyle (HEAL) Program', 'type': 'BEHAVIORAL', 'description': 'Evidence-based lifestyle medicine program for cancer survivors'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amanda Sawyer, PhD', 'role': 'CONTACT', 'email': 'amanda.sawyer@adventhealth.com'}, {'name': 'Tere Richard, MHSA', 'role': 'CONTACT', 'email': 'tere.richard@adventhealth.com'}, {'name': 'Amanda Sawyer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AdventHealth', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'centralContacts': [{'name': 'Amanda T. Sawyer, PhD', 'role': 'CONTACT', 'email': 'amanda.sawyer@adventhealth.com', 'phone': '407-200-2901'}, {'name': 'Tere Richard, MHSA', 'role': 'CONTACT', 'email': 'tere.richard@adventhealth.com', 'phone': '407-200-2901'}], 'overallOfficials': [{'name': 'Amanda T. Sawyer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AdventHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}