Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-04 @ 8:38 AM
Study NCT ID:
NCT05648604
Status:
COMPLETED
Last Update Posted:
2025-05-04
First Post:
2022-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mentored Community Gardening for Individuals With Skin Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2022-11-18', 'studyFirstSubmitQcDate': '2022-12-08', 'lastUpdatePostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health Related Quality of Life (HR-QOL)', 'timeFrame': '6 months', 'description': 'Functional Assessment of Cancer Therapy - Melanoma (FACT-M) is a melanoma specific questionnaire which will measure HR-QOL in participants. Items are measured on a 0-4 Likert scale.The FACT-M consists of 51 items with a total score ranging from 0-204. A higher score indicates better HR-QOL.'}, {'measure': 'Average acceptability of intervention', 'timeFrame': '6 months', 'description': 'Acceptability of intervention and sensors will be assessed using the Acceptability of Intervention Measure which includes 12 items on a 1-5 scale and summed. Scores range 12-60; higher scores reflect greater acceptability.'}], 'primaryOutcomes': [{'measure': 'Mean number of scheduled sessions a participant attends during intervention', 'timeFrame': '6 months', 'description': 'Adherence will be measured by attendance to the number of sessions (including weekly gardening, meetings with mentors, and group workshops) a participant attends.'}], 'secondaryOutcomes': [{'measure': 'UV Exposure', 'timeFrame': '6 months', 'description': 'Dosimeter (Scienterra) measured cumulative UV exposure \\[Units: Watts per square meter (W/m\\^2), UV Index (UVI), Standard Erythema Dose (SED), or Minimal Erythema Dose (MED)\\]'}, {'measure': 'Fruit and Vegetable Servings', 'timeFrame': '6 months', 'description': 'Dietary fruit and vegetable intake (average total servings/day) assessed by 24-hour dietary recall'}, {'measure': 'Total sedentary time', 'timeFrame': '6 months', 'description': 'Sedentary time (inactive minutes/day) measured by accelerometer (Actigraph Link GT9X)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nutrition', 'UV', 'Physical Activity', 'Gardening'], 'conditions': ['Melanoma', 'Cancer Survivorship', 'Skin Cancer', 'Basal Cell Carcinoma', 'Squamous Cell Carcinoma', 'Melanoma (Skin)']}, 'referencesModule': {'references': [{'pmid': '38595771', 'type': 'BACKGROUND', 'citation': 'Skiba MB, Miller D, Stratton DB, Hall CA, McKenna S, Blair CK, Demark-Wahnefried W. Adaptation and study protocol for harvest for health together Arizona: A mentored community garden intervention for survivors of cancer. Contemp Clin Trials Commun. 2024 Mar 28;39:101290. doi: 10.1016/j.conctc.2024.101290. eCollection 2024 Jun.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will conduct a single-arm pilot feasibility trial of mentored community gardening for melanoma survivors integrating dosimeters and accelerometers. Harvest for Health Together Arizona (H4H2-AZ) is an evidence-based program adapted for arid desert gardening that also addresses sun safety through group workshops and peer education. The primary aim is to evaluate adherence to the intervention.', 'detailedDescription': 'In collaboration with Banner Health, University of Arizona Cancer Center, Community Gardens of Tucson, and UArizona Pima County Cooperative Extension Master Gardeners, the investigators will conduct a pilot feasibility study of community gardening in melanoma survivors integrating UV sensors. Harvest for Health Together Arizona (H4H2-AZ) is an evidence-based program adapted for arid desert gardening that also addresses sun safety through experiential workshops and education. The investigators propose to evaluate adherence to and acceptability of the intervention. The investigators aim to see if H4H2-AZ may improve cancer preventive health behaviors (including diet, physical activity, energy balance, and UV protection) and quality of life among melanoma survivors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older at their last birthday \\& in good general health.\n* Clinical diagnosis of skin cancer (including in situ).\n* Has access to a phone or tablet with a camera and internet.\n* Currently living in Pima County Arizona.\n* Ability to understand and speak English.\n* Ability to provide written informed consent document.\n* Ability to physically participate in gardening activities (including kneeling, sitting, bending, and carrying up to 10 pounds) with or without the use of mobility assistive devices.\n\nExclusion Criteria:\n\n* Currently immunosuppressed by virtue of medication or disease.\n* Has a diagnosed and 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.'}, 'identificationModule': {'nctId': 'NCT05648604', 'acronym': 'H4H2-AZ', 'briefTitle': 'Mentored Community Gardening for Individuals With Skin Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'An Adapted Evidenced-Based Mentored Community Gardening Intervention for Skin Cancer Survivors: A Single-Arm Feasibility Study (Harvest for Health Together Arizona)', 'orgStudyIdInfo': {'id': '00002169'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mentored Community Gardening', 'description': 'This arm will consist of gardening at least once per week, meeting with a master gardener mentor bi-monthly, and attending a gardening informational workshop once monthly.', 'interventionNames': ['Behavioral: Mentored Community Gardening']}], 'interventions': [{'name': 'Mentored Community Gardening', 'type': 'BEHAVIORAL', 'description': 'This arm will consist of gardening at least once per week, meeting with a master gardening mentor twice monthly, and attending a gardening informational workshop once monthly.', 'armGroupLabels': ['Mentored Community Gardening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Meghan B Skiba, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona College of Nursing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Banner University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Meghan Skiba', 'investigatorAffiliation': 'University of Arizona'}}}}