Breast CancerNCT04587258
Improving Cancer Screening and Prevention During the COVID-19 Pandemic in Underserved Populations of Rhode Island
An observational study of Breast Cancer and Colorectal Cancer, run by Rhode Island Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Covid19
- What is being tested?
- Informational videos and social media campaigns encouraging cancer screening.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2020to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients that are at risk of colorectal or breast cancer from under-served or vulnerable communities in Rhode Island.
Who may be able to join
- Increased risk of either colorectal or breast cancer
- Living in an under-served area of Rhode Island
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Blackstone Valley Community Health Center
Pawtucket, Rhode Island, 02860
Cristina Pacheco, MD, 401-312-9898, cpacheco@bvchc.org
About this study
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.
Read the detailed description
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.
Dr. 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.
The 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
- Conditions
- Breast Cancer, Colorectal Cancer, Covid19
- Being tested
- Informational videos and social media campaigns encouraging cancer screening.
- 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
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational videos and social media campaigns encouraging cancer screening.Behavioural
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%.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer | Subjects will be encouraged through informational videos and social media campaigns to visit their doctors to get screened for breast cancer using mammograms. Receives: Behavioral: Informational videos and social media campaigns encouraging cancer screening. | |
| Colorectal Cancer | Subjects will be encouraged through informational videos and social media campaigns to visit their doctors to get screened for breast cancer using colonoscopies Receives: Behavioral: Informational videos and social media campaigns encouraging cancer screening. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
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.
Measured: 2 years
Secondary outcomes (2)
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.
Measured: 2 Years
Barriers to cancer screening during COVID19.
Evaluate barriers to cancer screening in these populations as it particularly relates to COVID19.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start28 Aug 2020
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Blackstone Valley Community Health Care
- Responsible party
- Sponsor
- Investigators
- Howard Safran, MD, Principal investigator, LifespanDon Dizon, MD, Principal investigator, Lifespan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587258
- Sponsor's protocol ID
- 1613494-3
- Status last verified
- Sep 2020
- First submitted
- 8 Oct 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30620402Wallerstein 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.
PubMed 20147663Braun 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.
PubMed 22095340Simonds 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.
PubMed 23680507Alberg AJ, Samet JM. Epidemiology of lung cancer. Chest. 2003 Jan;123(1 Suppl):21S-49S. doi: 10.1378/chest.123.1_suppl.21s.
PubMed 12527563National 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.
PubMed 21714641Pham 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)
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.
PubMed 32302078Zhou 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.
PubMed 32171076
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04587258
- Acronym / sponsor ID
- 1613494-3
- Conditions
- Breast Cancer, Colorectal Cancer, Covid19
- Keywords
- Cancer screening, COVID19, Underserved communities, Community based-participation, Social Media, Informational videos, Facebook, Instagram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Blackstone Valley Community Health Care
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Dr. 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.
The 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
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer | – | Behavioral: Informational videos and social media campaigns encouraging cancer screening.Subjects will be encouraged through informational videos and social media campaigns to visit their doctors to get screened for breast cancer using mammograms. |
| Colorectal Cancer | – | Behavioral: Informational videos and social media campaigns encouraging cancer screening.Subjects will be encouraged through informational videos and social media campaigns to visit their doctors to get screened for breast cancer using colonoscopies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients that are at risk of colorectal or breast cancer from under-served or vulnerable communities in Rhode Island.
Key inclusion criteria (2 listed)
- Increased risk of either colorectal or breast cancer
- Living in an under-served area of Rhode Island
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informational videos and social media campaigns encouraging cancer screening.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%. | Behavioural | Breast Cancer, Colorectal Cancer |
Primary outcome
Increase screening rates for breast and colorectal cancer
Time frame: 2 years
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.
Impact of screening on cancer care
Time frame: 2 years
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 secondary outcomes
Community Engagement
Time frame: 2 Years
Barriers to cancer screening during COVID19.
Time frame: 2 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 30620402Siegel 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.
- Background: PubMed 20147663Wallerstein 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.
- Background: PubMed 22095340Braun 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.
- Background: PubMed 23680507Simonds 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.
- Background: PubMed 12527563Alberg AJ, Samet JM. Epidemiology of lung cancer. Chest. 2003 Jan;123(1 Suppl):21S-49S. doi: 10.1378/chest.123.1_suppl.21s.
- Background: PubMed 21714641National 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.
- BackgroundPham 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)
- Background: PubMed 32302078Goyal 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.
- Background: PubMed 32171076Zhou 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.
- Blackstone Valley Community Health CenterLink provided by the sponsor.
- Lifespan Cancer InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Safran, MD principal investigator
Lifespan
Don Dizon, MD principal investigator
Lifespan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Colorectal Cancer, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Howard Safran, MD (1 (844) 222-2881, HSafran@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase screening rates for breast and colorectal cancer (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04587258, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.