Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-29 @ 12:48 AM
Study NCT ID:
NCT00394134
Status:
COMPLETED
Last Update Posted:
2019-09-13
First Post:
2006-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeted Intervention for Melanoma Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], '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': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-11', 'studyFirstSubmitDate': '2006-10-27', 'studyFirstSubmitQcDate': '2006-10-30', 'lastUpdatePostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patients'and Children's Sun Exposure and Protective Practices <Patient Interview Responses>", 'timeFrame': 'Baseline Interview, 6 Month and 9 Month Interviews', 'description': "Standard descriptive statistics computed for measures administered during structured interview, including means, standard deviations, ranges, measures of skew and kurtosis, together with 95% confidence intervals. Distributional characteristics of variables closely examined using boxplots, histograms, quantile-quantile plots, and the Kolmogorov-Smirnov test of normality.\n\nGeneral linear mixed-model approach used evaluate associations between patient socio-cognitive factors, psychological factors, phenotypic characteristics, and demographic characteristics; child phenotypic and demographic characteristics; and practices of participants to reduce their children's sun exposure, self-protective practices of participants, and sun exposure practices of children and participants."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melanoma', 'Sun Exposure', 'Sun Protection', 'Interview'], 'conditions': ['Melanoma']}, 'referencesModule': {'references': [{'pmid': '24097199', 'type': 'DERIVED', 'citation': 'Gritz ER, Tripp MK, Peterson SK, Prokhorov AV, Shete SS, Urbauer DL, Fellman BM, Lee JE, Gershenwald JE. Randomized controlled trial of a sun protection intervention for children of melanoma survivors. Cancer Epidemiol Biomarkers Prev. 2013 Oct;22(10):1813-24. doi: 10.1158/1055-9965.EPI-13-0249.'}], 'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': "In this study, the researchers will conduct interviews with melanoma patients to describe the sun exposure and sun protection practices of patients and their children. The researchers will use the findings of this interview study to develop a salient intervention targeted to the needs of melanoma patients and their children. The researchers will evaluate the intervention in a randomized, controlled trial.\n\nThe specific aims of this study are:\n\n* To interview 210 melanoma patients with children 12 years of age or younger to describe patients' socio-cognitive and psychological factors, describe patients' and children's sun exposure and sun protection practices, and identify determinants of patients' and children's sun exposure and protective practices.\n* To develop a targeted behavioral intervention that is designed to increase patients' protective practices to reduce their children's sun exposure, increase patients' self-protective practices, decrease the sun exposure levels of patients and their children, and positively influence socio-cognitive and psychological determinants of child-centered and self-protective practices.\n* To conduct a randomized, controlled trial in a sample of 360 melanoma patients with children 12 years of age or younger to evaluate the targeted behavioral intervention consisting of print and video materials. The intervention will be assessed for its effects on: 1) child sun exposure and sun protection; 2) patients' protective practices to reduce their children's sun exposure; 3) patients' sun exposure and self-protective practices; and 4) patients' socio-cognitive and psychological factors that facilitate behavior change.", 'detailedDescription': 'Research is to learn about awareness, attitudes, and behaviors related to sun exposure, sun protection, skin examination, and other risk-reducing behaviors. The results of this study will be used to design an educational program on sun protection for persons who have had melanoma and their children.\n\nThe study will involve a telephone interview that will last about 45 minutes and will be scheduled at your convenience. Your participation in this study is completely voluntary and you may refuse to participate. Your decision about participating will not affect the care or services you or your family may receive at The University of Texas M. D. Anderson Cancer Center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Melanoma patients are eligible if they were diagnosed with in situ, localized, or microscopic stage III melanoma after January 1, 1988.\n2. Melanoma patients are eligible if they are the parent of a child 12 years of age or younger and reside with the child.\n3. Melanoma patients are eligible if they provide informed consent.\n4. Melanoma patients are eligible if they are 18 years of age or older.\n5. Melanoma patients are eligible if they are able to speak, read, and write English.\n6. Melanoma patients are eligible if they meet all inclusion criteria.\n\nExclusion Criteria:\n\n1\\) Melanoma patients are not eligible if they cannot provide informed consent.'}, 'identificationModule': {'nctId': 'NCT00394134', 'briefTitle': 'Targeted Intervention for Melanoma Prevention', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Targeted, Family-Focused Intervention for Melanoma Prevention', 'orgStudyIdInfo': {'id': '2003-0901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Interview', 'description': 'Interviews to describe the sun exposure and sun protection practices of patients and their children.', 'interventionNames': ['Behavioral: Interview']}], 'interventions': [{'name': 'Interview', 'type': 'BEHAVIORAL', 'description': 'Interviews to describe the sun exposure and sun protection practices of patients and their children.', 'armGroupLabels': ['Interview']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Susan Peterson, PHD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}