Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Obesity

Diabetes Mellitus

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Risk assessment identified by online questionnaire

online questionnaire

Ruddy RICHARD

The state of health in France appears to be good with regard to major indicators such as life expectancy at birth.

However, France is characterized by a high standardized rate of premature mortality (deaths occurring before the age of 65) in comparison with other European countries, with geographical disparities. Between 2006 and 2010, the standardized rate of premature mortality was higher in Auvergne than the national average.

Chronic diseases such as cardiovascular diseases, cancers and / or metabolic diseases (including diabetes and obesity) are the main causes of these premature deaths. These diseases have several causes: they depend on the genetic heritage, the way of life and the environment. Family history is a known risk factor for these chronic diseases. Eating habits, insufficient physical activity or physical inactivity, excessive drinking and smoking which promote the occurrence of these chronic diseases are the main risk factors that we can modify. Preventive measures are known and are regularly the subject of public health plans and awareness campaigns targeting lifestyles modification of the populations. These prevention campaigns affect entire population, while the risk factors for chronic diseases are different from one to another, this encourages personalization of preventive measures. The CEPPPIA pilot study falls within this framework and aims to evaluate the feasibility of setting up an individualized prevention program on the modification of health behaviors among people aged 35 to 55, who has a moderate risk of developing chronic diseases and residing in Auvergne territory.

CEPPPIA Pilot. Experimental Center of Participative and Individualized Predictive Prevention in Auvergne

Number of volunteers who accepted to participate in the interventional phase / number of volunteers who can be included in the study Assess the feasibility of implementing an Individualized Prevention Program on the modification of health behaviors among people aged 35 to 55 years with a risk of developing chronic diseases (cardiovascular diseases, metabolic diseases and / or cancers) and residing in the territory of Auvergne by measuring partipation rate and satisfaction

Evaluation of the effectiveness of an individualized primary prevention program on changing health behaviors among people aged 35 to 55 years with a risk of developing chronic diseases (cardiovascular diseases, metabolic diseases and/or cancers)

Evaluate the effectiveness of an individualized primary prevention program on the modification of health behaviors among people aged 35 to 55, at risk of developing chronic diseases (cardiovascular diseases, metabolic diseases and / or cancers) and residing in Auvergne.

European Regional Development Fund

Conseil Régional Auvergne-Rhône-Alpes, Clermont-Ferrand, France.

Agence Régionale de Santé Rhône-Alpes

Ligue Contre le Cancer, Puy de Dôme, Allier et Cantal

GIE Auvergne Thermale

Centre Jean Perrin

UFR Médecine

UFR STAPS

Laboratoire d'Informatique, de Modélisation et d'Optimisation des Systèmes (LIMOS)

Centre de Recherche en Nutrition Humaine d'Auvergne

University Hospital, Clermont-Ferrand

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Lung Neoplasms

Prostatic Neoplasms

Breast Neoplasms

Gastrointestinal Diseases

Skin Neoplasms

Breast Diseases

Fibrocystic Breast Disease

Herbal and Botanical

All Drugs and Chemicals

Cola

The standard of care condition will include a portal that provides patients with access to existing online cancer clinical trial resources in one location. This includes links to pages with basic information about cancer clinical trials, ongoing studies, enrollment opportunities for existing institutional research registries, and contact information for study coordinators.

The virtual community health educator condition will provide all information in standard of care with the addition of a virtual community health educator. Patients will have the opportunity to choose which virtual community health educator will provide digital navigation. The choices will include at least four English-speaking and four Spanish-speaking virtual community health educators representing different genders and racial/ethnic backgrounds.

Stand-alone Research Portal

Portal with Virtual Community Health Educator (vCHE)

Janice Krieger, PhD

Stephanie Gray, PhD

Benjamin Lok, PhD

Olveen Carrasquillo, MD

The purpose of this study is to pilot test and evaluate an existing tailored ALEX Research Portal to navigate Black and Hispanic adult cancer patients and their family members through referral to cancer clinical trials.

Racial and ethnic minorities represent the fastest growing segment of the United States adult population, yet they remain significantly underrepresented in cancer clinical trials (CCTs). Low trust in clinical research and recruitment approaches that fail to address multilevel barriers to CCT participation are key reasons for minority population underrepresentation. Community health educators (CHEs) improve trust in research among underrepresented populations, yet relying on exclusively on CHE availability can limit intervention reach. Virtual CHEs (vCHEs) improve scalability by extending CHE capabilities and capitalizing on remote recruitment techniques.The purpose of the current project is to increase referral of diverse participants to NCI-supported clinical trials via a culturally responsive, multi-level intervention that utilizes vCHEs to reach diverse populations. We will consolidate existing referral channels within the ALEX Research Portal. ALEX offers a custom experience for clinicians, CHEs, and patients to facilitate CCT referrals. Clinicians can utilize the portal to refer to CCTs; CHEs can use the portal to create an avatar that can provide introductory information to patients and schedule video-conference follow-ups; patients, families, and community members can use the portal to easily navigate to key information and make self-and other-referrals. The ability to streamline information to patients and CCT referrals to study coordinators is expected to improve the overall referral to CCTs. The ALEX Research Portal utilizes the adaptive virtual human technology developed at the University of Florida that provides users with culturally and linguistically tailored CCT information. The ALEX Research Portal will be developed and launched across three distinct geographic areas of Florida (Gainesville, Jacksonville, and Miami). This unique collaborative opportunity will provide access to participants representative of the racial and ethnic diversity of the state as well as cancer centers conducting CCTs associated with national networks (ETCTN, NCTN). Guided by the Interactive Systems Framework for dissemination and implementation, our goal is to increase referrals to CCTs by optimizing the ALEX Research Portal for broad use. The outcome will be an evidence-based intervention that can be widely disseminated to quickly increase the referral of diverse patients to CCTs. This project will be conducted in three phases: (Phase I) establish a baseline of referrals and accrual of diverse participants to CCTs across multiple Florida Center Centers, (Phase 2) adapt and pilot the ALEX Research Portal using a randomized controlled clinical trial, and (Phase 3) scale the intervention by dissemination via the OneFlorida network. The proposed study will result in an empirically-tested vCHE Research Portal for increasing trust in CCTs among diverse populations that can easily be adapted and disseminated across the state to overcome challenges associated with recruiting diverse participants to CCTs.

Study Team will recruit an ethnically diverse sample of eligible patients N = 350 (approximately 88 White/non-Hispanic participants, 88 White/Hispanic participants, 88 Black/non-Hispanic participants, and 88 Black/Hispanic participants), evenly distributed across Black/African-American, Hispanic/Latino, and white to complete the intervention.

A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials

Precision Clinical Trial Recruitment to Promote Cancer Health Equity Across Florida

A total of 350 patients from underrepresented groups will be recruited in this study and equally randomized into either a) standard-of-care web-based educational portal about clinical trials or a b) a web-based portal that includes a virtual Community Health Educator. Participants in both conditions will have the opportunity to self-refer (operationalized as expressing interest in being contacted) to a cancer clinical trial. The numbers of patients referred to a cancer clinical trial will be collected in both treatment groups and the proportions compared to determine whether adding a virtual Community Health Educator to web-based educational resources about cancer clinical trials will increase referrals of minority patients.

The 350 patients are assigned into 2 groups, and the outcome measure is the count number of self-referrals after treatment divided by the total number of patients for both groups.

Participants assigned to the portal with the virtual Community Health Educator (vCHE) will be able to choose a vCHE among a set with different characteristics. Data on participant preferences for particular vCHE characteristics will be collected.

The measure is the count number of the participants that choose the different characteristics of vCHE.

Participants who access the portal will first complete a Clinical Trials Attitudes questionnaire (pre-test) that assesses trust in cancer clinical trials (CCTs). Participants will complete the Clinical Trials Attitudes questionnaire (post-test) after interacting with the vCHE. The Clinical Trials Attitudes questionnaire is composed of a series of participant self-report Likert-scale items on the participant's understanding and attitudes of CCTs.

The change in responses to the Likert-scale items between the pre-intervention questionnaire and the post-intervention questionnaire will be the change in trust in CCTs.

Potential mediators of intervention effectiveness, such as exposure to the intervention (i.e., whether participants clicked to open the application will be tracked by individual links to participants), psychological processing of content (e.g., comprehension, perceived message quality will be included in a post-intervention questionnaire), and self-reported communication with a healthcare provider about participation in clinical research (which will be measured through the two-week post-intervention communication), will be examined to determine whether they play an underlying mechanistic role between virtual community health educator and increased self-referrals.

Potential mediators will be evaluated individually, and multiple potential mediators will not be considered simultaneously.

National Cancer Institute (NCI)

University of Florida

Skin Diseases

Women participate in the counseling session, questionnaire 1, and questionnaire 2, and the online questionnaire.

Women participate in the counseling session, questionnaire 1 and questionnaire 2.

Counseling session

Questionnaire 1 assesses the recall and understanding of risk information given during the counseling session.

Questionnaire 1

Questionnaire 2 focuses on what factors, other thana the numerical risk-benefit analysis of SERM intake, are important in the decision-making process of women at increased risk for breast cancer.

Questionnaire 2

Norman Wolmark, MD

RATIONALE: Learning about how patients make decisions about using chemoprevention may help doctors plan treatment in which more patients are willing to choose chemoprevention to reduce their breast cancer risk.

PURPOSE: This clinical trial studies factors influencing decision-making about the use of chemoprevention in women at increased risk for breast cancer.

OBJECTIVES:

Primary

* To describe the influence of social, environmental, and psychological factors (sociality of medication intake, life-events, understanding of prevention, clinical situation) on the decision of women at risk for breast cancer as to whether or not to take chemoprevention agents.

Secondary

* To determine the implications of and influences on decision-making that a diagnosis of "being at risk for breast cancer" has for women.
* To determine what factors hinder women from taking chemoprevention for breast cancer.
* To field test a questionnaire that identifies the factors that influence the decision-making process of women at increased risk of breast cancer for whom chemoprevention is a medically indicated option.
* To describe the influence of social, environmental, and psychological factors on the decision of women at risk for breast cancer as to whether or not to take chemoprevention agents by menopausal status.
* For postmenopausal women who decide to take a selective estrogen-receptor modulator (SERM) for breast cancer prevention, to assess reasons for the choice of raloxifene versus tamoxifen.

OUTLINE: This is a multicenter study.

Participants undergo a counseling session about their increased risk for breast cancer and the use of a selective estrogen-receptor modulator (SERM), tamoxifen citrate or raloxifene, to reduce breast cancer risk. Some participants may have their counseling session video-recorded. They are also asked to review the video with their interviewers and to be contacted for a brief follow-up telephone interview.

Participants then complete an initial questionnaire to assess recall and understanding of risk information given to them during the counseling session. This first questionnaire is completed preferably on the same day of counseling before leaving the clinic or office. Participants also have the option to take the questionnaire home and return it to the study site within 2 weeks. Participants who return the first questionnaire complete a second one before leaving the clinic or office, or receive it by mail with a returned self-addressed stamped envelope. Participants who indicate on the second questionnaire that they do not want to take a SERM are asked to complete an online questionnaire. Participants who have not made a decision about SERM use within 3 months after counseling are contacted by telephone. They also receive the second questionnaire by mail 3 months after the telephone contact.

Interviewers, doctors, or other health-care professionals also complete questionnaires that indicate what was discussed during counseling sessions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CEPPPIA Pilot. Experimental Center of Participative and Individualized Predictive Prevention in Auvergne	NCT03378895	Chronic Disease Cardiovascular ... Cancers Diabetes Mellit... Obesity	online question...	35 Years - 55 Years	University Hospital, Clermont-Ferrand
CEPPPIA Pilot. Experimental Center of Participative and Individualized Predictive Prevention in Auvergne	NCT03378895	Chronic Disease Cardiovascular ... Cancers Diabetes Mellit... Obesity	online question...	35 Years - 55 Years	University Hospital, Clermont-Ferrand
A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials	NCT05655494	Cancer	Stand-alone Res... Portal with Vir...	18 Years - 100 Years	University of Florida
Factors Influencing Decision-Making About the Use of Chemoprevention in Women at Increased Risk for Breast Cancer	NCT01399359	Breast Cancer	Counseling sess... Questionnaire 1 Questionnaire 2 online question...	35 Years - 120 Years	NSABP Foundation Inc

Spots Global Cancer Trial Database for online questionnaire