Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-28 @ 8:05 PM
Study NCT ID:
NCT04587258
Status:
UNKNOWN
Last Update Posted:
2020-10-14
First Post:
2020-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Cancer Screening and Prevention During the COVID-19 Pandemic in Underserved Populations of Rhode Island
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D000086382', 'term': 'COVID-19'}], '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'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-13', 'studyFirstSubmitDate': '2020-10-08', 'studyFirstSubmitQcDate': '2020-10-13', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Educate the community on the importance of cancer screening', 'timeFrame': '5-10 years', 'description': 'We will educate staff, community physicians and Rhode Island residents on the importance of cancer screening. We will use community-based partnerships to overcome distrust of institutions and develop an engaged community network. Long term academic goals include publication of data and successfully receiving local and federal funding for continued research.'}], 'primaryOutcomes': [{'measure': 'Increase screening rates for breast and colorectal cancer', 'timeFrame': '2 years', 'description': 'Increase screening rates for breast and colorectal cancer among underserved populations by 25% using March 9 through May 31 as a benchmark, coinciding the Executive Orders for COVID19 announced by Governor Raimondo.'}, {'measure': 'Impact of screening on cancer care', 'timeFrame': '2 years', 'description': "Evaluate the impact of screening on timeliness of cancer care among these populations by comparing to the American Society of Clinical Oncology's Quality Oncology Performance Initiative (QOPI) guidelines in breast and colorectal cancer."}], 'secondaryOutcomes': [{'measure': 'Community Engagement', 'timeFrame': '2 Years', 'description': 'Evaluate strategies of engagement in these communities as it relates to:\n\n-Social media platform (Twitter, Facebook, Instagram, TikTok) These metrics will be determined by social media statistics for engagement and the number of calls/queries to the designated information lines.'}, {'measure': 'Barriers to cancer screening during COVID19.', 'timeFrame': '2 Years', 'description': 'Evaluate barriers to cancer screening in these populations as it particularly relates to COVID19.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer screening', 'COVID19', 'Underserved communities', 'Community based-participation', 'Social Media', 'Informational videos', 'Facebook', 'Instagram', 'TikTok', 'Lifespan', 'Blackstone Valley', 'Central Falls', 'Pawtucket', 'Providence', 'Minorities', 'Equitable healthcare'], 'conditions': ['Breast Cancer', 'Colorectal Cancer', 'Covid19']}, 'referencesModule': {'references': [{'pmid': '30620402', 'type': 'BACKGROUND', 'citation': 'Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34. doi: 10.3322/caac.21551. Epub 2019 Jan 8.'}, {'pmid': '20147663', 'type': 'BACKGROUND', 'citation': 'Wallerstein N, Duran B. Community-based participatory research contributions to intervention research: the intersection of science and practice to improve health equity. Am J Public Health. 2010 Apr 1;100 Suppl 1(Suppl 1):S40-6. doi: 10.2105/AJPH.2009.184036. Epub 2010 Feb 10.'}, {'pmid': '22095340', 'type': 'BACKGROUND', 'citation': "Braun KL, Nguyen TT, Tanjasiri SP, Campbell J, Heiney SP, Brandt HM, Smith SA, Blumenthal DS, Hargreaves M, Coe K, Ma GX, Kenerson D, Patel K, Tsark J, Hebert JR. Operationalization of community-based participatory research principles: assessment of the national cancer institute's community network programs. Am J Public Health. 2012 Jun;102(6):1195-203. doi: 10.2105/AJPH.2011.300304. Epub 2011 Nov 28."}, {'pmid': '23680507', 'type': 'BACKGROUND', 'citation': 'Simonds VW, Wallerstein N, Duran B, Villegas M. Community-based participatory research: its role in future cancer research and public health practice. Prev Chronic Dis. 2013 May 16;10:E78. doi: 10.5888/pcd10.120205.'}, {'pmid': '12527563', 'type': 'BACKGROUND', 'citation': 'Alberg AJ, Samet JM. Epidemiology of lung cancer. Chest. 2003 Jan;123(1 Suppl):21S-49S. doi: 10.1378/chest.123.1_suppl.21s.'}, {'pmid': '21714641', 'type': 'BACKGROUND', 'citation': 'National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.'}, {'type': 'BACKGROUND', 'citation': 'Pham D, Bhandari S, Oechsli M, et al, Lung cancer screening rates: Data from the lung cancer screening registry. J Clin Oncol 36, 2018 (suppl; abstr 6504)'}, {'pmid': '32302078', 'type': 'BACKGROUND', 'citation': 'Goyal P, Choi JJ, Pinheiro LC, Schenck EJ, Chen R, Jabri A, Satlin MJ, Campion TR Jr, Nahid M, Ringel JB, Hoffman KL, Alshak MN, Li HA, Wehmeyer GT, Rajan M, Reshetnyak E, Hupert N, Horn EM, Martinez FJ, Gulick RM, Safford MM. Clinical Characteristics of Covid-19 in New York City. N Engl J Med. 2020 Jun 11;382(24):2372-2374. doi: 10.1056/NEJMc2010419. Epub 2020 Apr 17. No abstract available.'}, {'pmid': '32171076', 'type': 'BACKGROUND', 'citation': 'Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.'}], 'seeAlsoLinks': [{'url': 'http://www.bvchc.org/', 'label': 'Blackstone Valley Community Health Center'}, {'url': 'https://www.lifespan.org/centers-services/lifespan-cancer-institute', 'label': 'Lifespan Cancer Institute'}]}, 'descriptionModule': {'briefSummary': "Lifespan Cancer Institute serves over 50% of cancer patients in the state. Rhode Island is known for strong medical care and high rates of cancer screening with mammography and colonoscopy. However, cancer screening has plummeted during the COVID-19 pandemic, in part to closing physician offices and stopping non-urgent medical procedures. In addition, anecdotal reports suggest the public remains concerned about returning to physician's offices and risking possible exposure to COVID-19. As in the United States as a whole, COVID-19 has disproportionately impacted ethnic and minority individuals within underserved communities; and in Rhode Island, African Americans, Hispanics and undocumented individuals living in communities such as Central Falls, Pawtucket, Providence, East Providence and North Providence have had the highest rate of COVID-19. These communities are also impacted by healthcare disparities to access and affordability of healthcare, and as such, may be among the least likely to resume cancer screening.\n\nThe Lifespan Cancer Institute will institute a project to address health disparities in cancer screening during the pandemic through the use of a targeted campaign involving social media. The goals will be to re-establish screening in the era of COVID-19 and ensure timeliness of care for those found to be at risk, or are positive for, cancer.", 'detailedDescription': 'This project will focus on improving breast and colorectal cancer screening during the COVID-19 pandemic in underserved populations of Rhode Island. The investigators will engage the Blackstone Valley Community Health Center. Dr. Don Dizon, a national leader in social media, will be a key participant.\n\nDr. Don Dizon is a world expert using electronic communication and social media in the oncology practice. Dr. Dizon chairs the Digital Engagement Committee for the Southwest Oncology Group (SWOG) a national cancer institute cooperative group. He is a co-principal investigator of an NIH grant studying electronic patient reported outcomes - the SIMPRO Research Consortium. Dr. Dizon is also head of the American Society of Oncology (ASCO) Educational Committee and is well positioned to disseminate the knowledge gathered from the current project through ASCO activities.\n\nThe initial project may be to discuss with the Blackstone Valley Community Health Center the possibility of developing short videos in multiple languages on the importance of cancer screening. The investigators will engage staff and patients of the BVCHC and the community to participate within the videos as a model of community-based participation. These informational videos could be distributed directly to the community via social media platforms. Data will be collecting on the rates of cancer screening including age, sex and race. These data could be compared to different cities within Rhode Island and the United States'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that are at risk of colorectal or breast cancer from under-served or vulnerable communities in Rhode Island.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Increased risk of either colorectal or breast cancer\n* Living in an under-served area of Rhode Island\n\nExclusion Criteria:\n\n\\- None'}, 'identificationModule': {'nctId': 'NCT04587258', 'briefTitle': 'Improving Cancer Screening and Prevention During the COVID-19 Pandemic in Underserved Populations of Rhode Island', 'organization': {'class': 'OTHER', 'fullName': 'Rhode Island Hospital'}, 'officialTitle': 'Improving Cancer Screening and Prevention During the COVID-19 Pandemic in Underserved Populations of Rhode Island: A Community Based Quality Improvement Project of the Lifespan Cancer Institute', 'orgStudyIdInfo': {'id': '1613494-3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast Cancer', 'description': 'Subjects will be encouraged through informational videos and social media campaigns to visit their doctors to get screened for breast cancer using mammograms.', 'interventionNames': ['Behavioral: Informational videos and social media campaigns encouraging cancer screening.']}, {'label': 'Colorectal Cancer', 'description': 'Subjects will be encouraged through informational videos and social media campaigns to visit their doctors to get screened for breast cancer using colonoscopies', 'interventionNames': ['Behavioral: Informational videos and social media campaigns encouraging cancer screening.']}], 'interventions': [{'name': 'Informational videos and social media campaigns encouraging cancer screening.', 'type': 'BEHAVIORAL', 'description': 'Informational videos will be made using community members and will be played in the Blackstone Valley Health Center, as well as posted on social media platforms, such as Facebook and Instagram. These videos will encourage at risk populations in the selected areas to visit their physicians to discuss the possibility of undergoing screening procedures for either breast or colorectal cancer. Data will then be collected about the rates of screening and will be compared to the screening rates from the time period of March 9th 2020 to May 31st 2020, with the goal of increasing screening rates by 25%.', 'armGroupLabels': ['Breast Cancer', 'Colorectal Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02860', 'city': 'Pawtucket', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cristina Pacheco, MD', 'role': 'CONTACT', 'email': 'cpacheco@bvchc.org', 'phone': '401-312-9898'}], 'facility': 'Blackstone Valley Community Health Center', 'geoPoint': {'lat': 41.87871, 'lon': -71.38256}}], 'centralContacts': [{'name': 'Howard Safran, MD', 'role': 'CONTACT', 'email': 'HSafran@lifespan.org', 'phone': '1 (844) 222-2881'}], 'overallOfficials': [{'name': 'Howard Safran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lifespan'}, {'name': 'Don Dizon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lifespan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhode Island Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Blackstone Valley Community Health Care', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}