Viewing Study NCT00597961


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Study NCT ID: NCT00597961
Status: COMPLETED
Last Update Posted: 2020-04-16
First Post: 2008-01-09
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Health Communication in Families
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-15', 'studyFirstSubmitDate': '2008-01-09', 'studyFirstSubmitQcDate': '2008-01-17', 'lastUpdatePostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'We will use data from our qualitative interviews to develop a family-focused assessment battery for examining risk perception and risk communication in families affected by cancer.', 'timeFrame': '7 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lung', 'skin', 'melanoma'], 'conditions': ['Lung Cancer', 'Melanoma', 'Skin Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan-Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'There are two goals of this research study. First, we hope to develop a plan to guide family discussions that can help parents diagnosed with lung cancer talk about cancer risk with their adult children. Second, we want to understand how families talk about cancer prevention.', 'detailedDescription': 'In large part due to the advent of genetic testing, families have recently become a more central focus in cancer prevention. Given the high concordance of health behaviors within families (Kristeller et al., 1996), there is interest in developing family-wide behavior change interventions to reduce cancer risk. A cancer diagnosis represents a "teachable moment," in which a diagnosis may prompt health behavior change. Although this phenomenon has been observed among cancer survivors, it has not been examined among a patient\'s family members. Several critical questions exist about how families understand and communicate with regard to cancer risk information and what family processes facilitate or impede health behavior change. There is very little existent research in the area of cancer prevention among family members of cancer patients. Results in this area could help us develop interventions for family members who are motivated to make health behavior changes, and to inform and guide others who may not be motivated at the time their family member is diagnosed. Most importantly, the results could also help us intervene with family members of those who have been diagnosed with cancers where genetic and lifestyle components are important in the etiology of the illness, such as lung cancer and melanoma, and thus first-degree family members would benefit from strong messages to adopt healthy lifestyles. The research will rely on qualitative data collection and analysis. We will conduct qualitative interviews with 20 pairs of melanoma patients and one adult son or daughter, and 20 pairs of lung cancer patients and one adult child/sibling/or spouse. More specifically, for each pair of participants (i.e., the patient and his/her family member) we will conduct three interviews: an individual interview with the patient, an individual interview with the family member, and a joint interview where we will talk to the patient and family member at the same time. We will analyze interview data with a qualitative data computer analysis program, and identify themes and conclusions representing the core ideas in our data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Concentrating on two distinct tumor types, lung cancer and melanoma, because of the prominence of risk behaviors in the etiology of both of these cancers. With regard to lung cancer, we have identified high concordance of smoking among the spouses, siblings and children of recently diagnosed patients. In the context of melanoma, patients report a desire to use focused family discussions to encourage family members to reduce their skin cancer risk and increase early detection behaviors.\n\n"Family" defined as a group consisting of blood relatives, domestic partners, \\& on-blood relatives as defined by cancer patient. During interviews with melanoma-affected families we will be gathering data from a melanoma patient \\& ne of their adult sons or daughters. During the interviews with lung cancer-affected families we will be gathering data from a lung cancer patient and either one of their adult children, or one of their siblings, or their spouse.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lung cancer patients must have a history of smoking.\n* Family members of lung cancer patients must be active smokers in order to participate in the study.\n* All participants must be more than 18 years of age and be fluent in English.\n* Patients must have received a diagnosis of either lung cancer or melanoma within the past 3 to 18 months.'}, 'identificationModule': {'nctId': 'NCT00597961', 'briefTitle': 'Health Communication in Families', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Health Communication in Families', 'orgStudyIdInfo': {'id': '03-088'}}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jamie Ostroff, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}