Breast Cancer Clinical Trial
Official title:
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
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.
The 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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Increased risk of either colorectal or breast cancer - Living in an under-served area of Rhode Island Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United States | Blackstone Valley Community Health Center | Pawtucket | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Rhode Island Hospital | Blackstone Valley Community Health Care |
United States,
Alberg AJ, Samet JM. Epidemiology of lung cancer. Chest. 2003 Jan;123(1 Suppl):21S-49S. Review. — View 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, Hébert 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. — View 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. — View 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. — View 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)
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. — View 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. — View 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:S40-6. doi: 10.2105/AJPH.2009.184036. Epub 2010 Feb 10. — View 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. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Educate the community on the importance of cancer screening | 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. | 5-10 years | |
Primary | Increase screening rates for breast and colorectal cancer | 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. | 2 years | |
Primary | Impact of screening on cancer care | 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. | 2 years | |
Secondary | Community Engagement | Evaluate strategies of engagement in these communities as it relates to: -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. |
2 Years | |
Secondary | Barriers to cancer screening during COVID19. | Evaluate barriers to cancer screening in these populations as it particularly relates to COVID19. | 2 Years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |