Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Receives decision aid intervention that encompasses balance sheets, navigation, audio files, and interaction -- Cancer Health Aid to Manage Preferences and Improve Outcomes through Navigation (CHAMPION)

An interactive mHealth decision aid that includes immediate and over time quality of life (QL) graphical summaries for advanced prostate cancer patients to enhance informed, shared decision making and will also be used to assess the CPNs' role in the decision-making process.

CHAMPION

Randy A Jones, PhD,RN,FAAN

Jane Gildersleeve, MSN

Jennifer Wenzel, PhD,RN,FAAN

Richard Brown, PhD

Prostate cancer is a commonly diagnosed cancer, and is the second leading cause of cancer deaths among men in the U.S. The subgroup of men with advanced prostate cancer is particularly vulnerable to difficult choices for treatment because of the nature of their disease and having limited options. This study will test the use of an innovative Registered Nurse-Community Patient Navigator team delivered interactive mHealth decision aid for patients with advanced prostate cancer to help facilitate informed shared decisions about anti-cancer treatment that affects their quality of life.

Many patients with advanced prostate cancer along with their decision partners/ proxies (DPP) struggle with complex treatment decisions, such as when to start, change, or stop cancer directed treatment. Despite the utility of decision aids (DAs) to address decisional conflict, little is known about treatment decision-making for advanced cancers. The study's primary aim is to test the effects of a theory- based mHealth DA (CHAMPION) administered by Registered Nurse (RN)-Community Patient Navigator (CPN) teams to advanced prostate cancer patients and decision partners/proxies on the following outcomes: less decisional conflict/uncertainty, higher psychosocial quality of life domain (HRQL-PSY), and less regret at the time of making an anti-cancer treatment decision. The secondary aim is to evaluate the CPN role in delivery of the mHealth DA (CHAMPION) from the patients' and decision partners/proxies' perspective. Preliminary estimates of treatment effects by race to see if the data support a larger effect among African Americans versus Others in the primary and secondary aims will also be explored. This mixed-methods population-based randomized controlled trial will gather data from 158 patient/DPP pairs at three sites: University of Virginia Emily Couric Cancer Center, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, and Virginia Commonwealth University Massey Cancer Center. The pretest/posttest design will measure a time period that includes three single-event decisions over the course of their cancer-directed treatment; and a qualitative retrospective design will allow exploring the experiences of both patients and their DPPs separately in an interview at the completion of the study. Stratification by race (African-American and Caucasian/Other) and decision point (starting vs. changing vs. stopping anticancer treatment) will be used. There will be two groups: the control (enhanced usual care \[EUC\]) group and the decision intervention (DI) group. The DI group will receive an interactive 7-component cognitive-behavioral skills mHealth program (DA) with a RN-CPN team, primarily focusing on decision-making during cancer treatment. Self-report measures will be used for all participants in addition to probes for the taped interviews with DI. The primary outcome measures are 1) decisional conflict (uncertainty), 2) decisional regret, 3) HRQL-PSY, and 4) decision-making participation preference. Generalized linear models will be used for data analysis for the quantitative component, and qualitative evaluation of the intervention will be conducted to capture each pair's experience of the CHAMPION intervention. This innovative mHealth DA delivered by a CPN is expected to increase acceptability and the uptake of both the DA and the technology components. This addresses several NIH/NINR innovative questions, through the use of information technology to promote health-related decision-making for providers and patients, examining patient outcomes for improvement in healthcare, as well as to engage and support individuals such as extended family, lay coaches, etc. to augment provider care and recommendations.

Decision Navigation for Advanced Prostate Cancer Treatment Options Using mHealth

demonstrate less decisional conflict/uncertainty, higher QL (HRQL-PSY domain) and less regret at the time of making an anti-cancer treatment decision

evaluate community patient navigator role in delivery of decision aid

Johns Hopkins University

Virginia Commonwealth University

University of Virginia

Associate Professor

Skin and Connective Tissue Diseases

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Breast Neoplasms

COVID-19

Pneumonia

Pneumonia, Viral

Communicable Diseases

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

Subjects will be encouraged through informational videos and social media campaigns to visit their doctors to get screened for breast cancer using mammograms.

Subjects will be encouraged through informational videos and social media campaigns to visit their doctors to get screened for breast cancer using colonoscopies

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%.

Informational videos and social media campaigns encouraging cancer screening.

Howard Safran, MD

Cristina Pacheco, MD

Don Dizon, MD

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.

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

Improving Cancer Screening and Prevention During the COVID-19 Pandemic in Underserved Populations of Rhode Island

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

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.

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.

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.

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.

Evaluate barriers to cancer screening in these populations as it particularly relates to COVID19.

Blackstone Valley Community Health Care

Rhode Island Hospital

Wounds and Injuries

Fractures, Stress

Fractures, Bone

Breast Diseases

Skin Diseases

Despite increased access to early detection and the availability of more effective therapeutic strategies, African American women continue to experience excess rates of morbidity and mortality from breast cancer. An emerging hypothesis about breast cancer disparities is that social conditions and physiological responses to social stressors influence biological processes that are important to the initiation and progression of disease. This hypothesis is based on data from animal studies which have shown that rats that are exposed to social stressors such as isolation are likely to develop mammary tumors that are histologically and etiologically similar to those that develop among African American women. The HPA axis plays a central role in regulating the physiological stress response; dysregulation of the HPA has been suggested as a mechanism through which social and biological factors contribute to racial disparities in breast cancer outcomes. Many African Americans experience stressful life events and circumstances, including economic, discriminatory, and other stressors. These social factors may contribute to an increased risk of advanced stage disease, but not all African American women who are exposed to adverse social factors develop advanced stage disease and those who have a limited number of psychosocial stressors can develop advanced stage breast cancer, regardless of early detection. This may be because stress reactivity, or one's physiological and psychological responses to a stressor, is highly individualized and dependent on psychological and social determinants as well as genetic factors. But, these biological and psychosocial pathways have not been examined among women at increased risk for disparities. Therefore, this study will characterize stress reactivity and emotional regulation among African American breast cancer survivors and measure the association between these responses and decisions about cancer control and treatment compliance. As part of providing empirical data on biological and psychological pathways that contribute to breast cancer disparities, the investigator's study will identify novel intervention targets that can be used to improve self-management in a population that is at risk for limited cancer control.

Dysregulation of the HPA has been suggested as a mechanism through which social and biological factors contribute to racial disparities in breast cancer outcomes.The HPA axis plays a central role in regulating the physiological stress response;a prolonged and elevated glucocorticoid (GC) response following a social stressor predicts tumor growth rates and the development of mammary cancer in rats that histologically and etiologically resembles human disease.Many African Americans experience stressful life events and circumstances, including economic, discriminatory, and other stressors. These psychosocial factors may contribute to an increased risk of advanced stage breast cancer among African American women, but not all African American women who are exposed to adverse psychosocial and social stressors develop advanced stage breast cancer and African American women who have a limited number of stressors also develop advanced stage breast cancer, regardless of early detection. This may be because stress reactivity, or one's physiological and psychological responses to a stressor, is highly individualized and dependent on psychological and social determinants. However, empirical data are not available on stress reactivity among African American breast cancer survivors and how these reactions vary among women based on their exposure to chronic stressors and psychological characteristics. Empirical data are also lacking on the association between stress reactivity and cancer control behaviors among African American breast cancer survivors even though prior studies have shown that these women are less likely than whites to engage in health behaviors that are important to cancer control and research is now being conducted to understand how stress affects these behaviors.This research is testing the hypothesis that stress: (1) promotes temporal discounting; (2) has an adverse effect on self-efficacy, and (3) reduces executive functioning (e.g., goal setting, planning). However, stress reactivity, and the association between these responses and cancer control behaviors (e.g., diet, physical activity, and treatment compliance), have not been examined among African American breast cancer survivors. Prior studies have shown that African Americans have a dysregulated stress response as a result of persistent exposure to chronic and acute and stressors; this may alter stress responses and lead to high levels of allostatic load. In order to develop effective behavioral interventions for African American breast cancer survivors, an important first step is to verify that the mechanisms (e.g., temporal discounting, self-efficacy) involved in health behaviors for cancer control (e.g., diet, physical activity, treatment compliance) are associated with stress reactivity among these women. Therefore this study will characterize stress reactivity among African American breast cancer survivors and validate the association between these responses and targeted mechanisms of behavior change.

Blood samples, urine samples, and saliva samples

Due to the nature of this study, only women who were born biologically as female will be eligible to participate in this study. Men who develop breast cancer have a different pathophysiology than women, and therefore, will not be included in this sample.

Stress Reactivity Among African American Breast Cancer Survivors

The Science of Behavior Change in African American Breast Cancer Survivors

Conduct an A Tier Social Stress Test (TSST)with patients to induce a stress response. Cortisol is being examined as a stress biomarker and will be measured at baseline, at multiple timepoints (n=3) during the TSST, and immediately after the TSST to assess changes in cortisol levels.

Collect vital assessments that include heart rate and systolic and diastolic blood pressure at baseline, during the course of the Trier Social Stress Test (TSST), and immediately after the TSST in order to examine changes in vitals as it relates to stress responses during the TSST.

Characterize the nature and distribution of stress reactivity among African American breast cancer survivors based on socioeconomic, clinical, and social stressors. Socioeconomic status will be collected via self-report utilizing household income and education items from the Behavioral Risk Factor Surveillance System (BRFSS) tool. Financial strain will be evaluated using the Comprehensive Score for financial Toxicity (COST) tool. Social stress will be assessed by levels of social isolation using the loneliness scale. Clinical variables relating to disease stage will be extracted from the patient's electronic medical record.

A blood sample will determine circulating levels of neutrophils, lymphocytes, and monocytes to determine glucocorticoid sensitivity.

The Kirby Delay Discounting Task conducted immediately (10 minutes) or longer (20 minutes) following exposure to the Trier Social Stress Test to examine temporal discounting.

Self-reported diet behaviors will be associated with levels of stress reactivity 1-month following stress induction.

Self-reported physical activity behaviors will be associated with levels of stress reactivity 1-month following stress induction.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Decision Navigation for Advanced Prostate Cancer Treatment Options Using mHealth	NCT03327103	Decision Suppor...	CHAMPION	18 Years -	University of Virginia
Improving Cancer Screening and Prevention During the COVID-19 Pandemic in Underserved Populations of Rhode Island	NCT04587258	Breast Cancer Colorectal Canc... Covid19	Informational v...	18 Years -	Rhode Island Hospital
Improving Cancer Screening and Prevention During the COVID-19 Pandemic in Underserved Populations of Rhode Island	NCT04587258	Breast Cancer Colorectal Canc... Covid19	Informational v...	18 Years -	Rhode Island Hospital
Stress Reactivity Among African American Breast Cancer Survivors	NCT03881085	Breast Cancer F... Stress Reaction		21 Years - 75 Years	Medical University of South Carolina
Decision Navigation for Advanced Prostate Cancer Treatment Options Using mHealth	NCT03327103	Decision Suppor...	CHAMPION	18 Years -	University of Virginia

Spots Global Cancer Trial Database for minorities

Every month we try and update this database with for minorities cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for minorities

Every month we try and update this database with for minorities cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for minorities cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.