Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT05434702
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-31
First Post:
2022-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"COACH" Study: Individualized COaching in Young Adult Cancer Survivors to Encourage Healthy Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-30', 'studyFirstSubmitDate': '2022-06-17', 'studyFirstSubmitQcDate': '2022-06-23', 'lastUpdatePostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aim 1: Quality of Life in YA Cancer Survivors -EORTC-QOL', 'timeFrame': 'Week 1', 'description': "Quality of life will be measured using the EORTC-QOL questionnaire. The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) includes questions about participant's quality of life during the past week, self-reported general health, self reported chronic conditions and psychological distress using a scale from 1-5, 1=excellent, 5= poor. A lower total score indicates better qualify of life"}, {'measure': 'Aim 1: Quality of Life in YA Cancer Survivors -FACT-G', 'timeFrame': 'Week 1', 'description': "Quality of life will be measured using the FACT-G questionnaire. The Functional Assessment of Cancer Therapy - General (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."}, {'measure': 'Aim 1: Physical Activity in YA cancer Survivors - Questionnaire', 'timeFrame': 'Up to 2 weeks', 'description': "Frequency and intensity of physical activity will be measured using the Godin Exercise leisure time questionnaire. The Godin Exercise Leisure-Time questionnaire measures the frequency of strenuous, moderate, and mild exercise for periods of 15 minutes or more during the participant's free time throughout a typical week. The scoring using the formula leisure score index (LSI) which is obtained using the following formula: (frequency of mild × 3) + (frequency of moderate × 5) + (frequency of strenuous × 9)."}, {'measure': 'Aim 1: Physical Activity in YA cancer Survivors - Fitbit data', 'timeFrame': 'Up to 2 weeks', 'description': 'Frequency and intensity of physical activity will be measured using Fitbit data.'}, {'measure': 'Aim 1: Healthy eating in YA cancer survivors', 'timeFrame': 'Up to 2 weeks', 'description': 'Data from the the food frequency questionnaire along with digital diet diary will be compared to American Cancer Society dietary guidelines.'}], 'secondaryOutcomes': [{'measure': 'Aim 2: Development of educational intervention for YA cancer survivors', 'timeFrame': 'Up to 24 months', 'description': 'Data collected from zoom interviews with a sub-set participants will be used to provide study team with information needed to develop healthy behavior interventions for young adult cancer survivors.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Young Adult', 'Cancer survivor'], 'conditions': ['Health Behavior']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.moffitt.org/clinical-trials-research/clinical-trials/?gclid=EAIaIQobChMImIymzIa-9gIVAZ2GCh3uzAWJEAAYASAAEgI0ovD_BwE', 'label': 'Moffitt Cancer Center Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to better understand the current lifestyle behaviors that people with a young adult cancer diagnosis have after treatment. Investigators are also interested in understanding what affects the quality of life of young adult cancer survivors. Investigators will use this information to develop and test a diet and physical activity intervention to help young adult cancer survivors feel their best'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Primarily participants in Moffitt Cancer Center's Adolescent and Young Adult Survivorship program", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with cancer between the ages of 19 and 29\n* Currently between the ages of 20 and 30 years old\n* At least 1 year post-adjuvant therapy\n* Able to read/speak English\n* Able to complete an online survey\n* Able to consume food orally\n\nExclusion Criteria:\n\n* Women who are pregnant'}, 'identificationModule': {'nctId': 'NCT05434702', 'briefTitle': '"COACH" Study: Individualized COaching in Young Adult Cancer Survivors to Encourage Healthy Behaviors', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'The "COACH" Study: Individualized COaching in Young Adult Cancer Survivors to Encourage Healthy Behaviors', 'orgStudyIdInfo': {'id': 'MCC-21786'}, 'secondaryIdInfos': [{'id': 'R03CA270475', 'link': 'https://reporter.nih.gov/quickSearch/R03CA270475', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Young adult cancer survivors', 'description': 'Adolescent and young adult cancer survivors', 'interventionNames': ['Behavioral: Digital Diet Diary', 'Behavioral: NHANES Food Frequency Questionnaire (FFQ)', 'Behavioral: Fitbit data collection', 'Behavioral: Quality of Life questionnaire', 'Behavioral: Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire', 'Behavioral: Godin Exercise Leisure-Time questionnaire', 'Behavioral: Zoom interviews']}], 'interventions': [{'name': 'Digital Diet Diary', 'type': 'BEHAVIORAL', 'description': "Participants will be asked to complete the Fitbit 3-day food record, which consists of inputting each food and beverage consumed for two weekdays and 1 weekend day into the Fitbit application. This digital diary includes taking photos of each food and beverage consumed during the 3 day food record period on the participant's iphone or ipad.", 'armGroupLabels': ['Young adult cancer survivors']}, {'name': 'NHANES Food Frequency Questionnaire (FFQ)', 'type': 'BEHAVIORAL', 'description': 'Participants will complete the the Food Frequency questionnaire which indicates usual food intake over the past year.', 'armGroupLabels': ['Young adult cancer survivors']}, {'name': 'Fitbit data collection', 'type': 'BEHAVIORAL', 'description': "Participants will be asked to wear a Fitbit continuously (24/7) for one week to track steps and activity intensity. The Fitbit is worn on the wrist and uses accelerometer and heart rate technology to quantify steps taken and integrated barometric altimeter to measure activity intensity. The resulting Fitbit data will be automatically pulled from the participant's smartphone or study device.", 'armGroupLabels': ['Young adult cancer survivors']}, {'name': 'Quality of Life questionnaire', 'type': 'BEHAVIORAL', 'description': "The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) includes questions about participant's quality of life during the past week, self-reported general health, self reported chronic conditions and psychological distress using a scale from 1-5, 1=excellent, 5= poor. A lower total score indicates better qualify of life.", 'armGroupLabels': ['Young adult cancer survivors']}, {'name': 'Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire', 'type': 'BEHAVIORAL', 'description': "The Functional Assessment of Cancer Therapy - General (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': ['Young adult cancer survivors']}, {'name': 'Godin Exercise Leisure-Time questionnaire', 'type': 'BEHAVIORAL', 'description': "The Godin Exercise Leisure-Time questionnaire measures the frequency of strenuous, moderate, and mild exercise for periods of 15 minutes or more during the participant's free time throughout a typical week. The scoring using the formula leisure score index (LSI) which is obtained using the following formula: (frequency of mild × 3) + (frequency of moderate × 5) + (frequency of strenuous × 9).", 'armGroupLabels': ['Young adult cancer survivors']}, {'name': 'Zoom interviews', 'type': 'BEHAVIORAL', 'description': 'A subset of 30 participants (10 African American, 10 Hispanic, 10 non-Hispanic white) will participate in semi-structured interviews to explore (a) sociocultural, environmental, and individual factors associated with lifestyle behaviors; (b) awareness of American Cancer Society (ACS) guidelines, current practices, and essential intervention modules (ex. integrating cultural foods and preferences) to provide study team with information needed to develop healthy behavior interventions for young adult cancer survivors.', 'armGroupLabels': ['Young adult cancer survivors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Heather S.L. Jim, PhD', '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': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}