Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Primer, FIT Kit, Reminders, Abnormal FIT Follow-up

We will mail an introductory letter to eligible individuals describing the importance of CRC screening and noting that follow-up mail will include a FIT Kit. Two weeks later they will receive a packet via mail containing the FIT kit, a one-page invitation inviting FIT completion and FIT instructions, COVID-19 messaging, and a postage-paid envelope for return.

Mailed FIT Outreach

The standardized navigation includes, but is not limited to, the following key components:

1. Identification of individuals with abnormal FIT
2. Results review and colonoscopy order by provider
3. Results reporting to patient
4. Insurance approval for colonoscopy
5. Colonoscopy scheduling
6. Bowel preparation \& colonoscopy completion
7. Colonoscopy results provided to patient and CHC
8. Referral-to-Care for patients with CRC (if necessary)

Standardized navigation

Maria E Martinez

Colorectal cancer (CRC) screening can reduce cancer deaths. However, screening and abnormal test follow-up rates are low among underserved populations. The screening rates of 19-58%, and rates of colonoscopy completion after abnormal stool tests of 18-57% in community health centers (CHC) systems are low. This highlights an opportunity to improve early detection and decrease burden of CRC in our region. Mailed outreach and navigation programs have been shown to increase colonoscopy completion rate. The next step is to understand how to best implement these programs in the community on a larger scale. To achieve this goal, the investigators propose a Hub-and-Spoke intervention combining centralized strategies to maximize CRC screening, follow-up, and referral-to-care. The investigators hypothesize that this intervention will be superior to usual care for increasing CRC screening, abnormal test follow-up, and referral-to-care.

The investigators will conduct a randomized trial to determine effectiveness in: 1) improvement in proportion of individuals up-to-date with screening 3 years post implementation; 2) proportion with abnormal FIT who complete diagnostic colonoscopy within 6 months; and 3) proportion with CRC completing first treatment evaluation.

The investigators will also evaluate the implementation, scalability, and sustainability of the multi-level implementation strategy. The intervention consists of: Mailed FIT and Reminders. Eligible individuals will receive an introductory letter describing the importance of CRC screening and noting that follow-up mail will include a FIT Kit. It will also be offered to patients who completed prior mailed FIT with normal test results. All materials will be in English and Spanish. Two weeks later, participants will receive a packet via mail containing the FIT kit, a one-page invitation inviting FIT completion and FIT instructions, a postage-paid envelope for return to the patient's CHC, and COVID-19 message. For non-compliant individuals not returning the kit, a reminder phone call and text message will be delivered 2 weeks later. The investigators will track returned letters, individuals who are later found to be up-to date with screening, and those who decline screening. The CHC will provide care coordination for patients with an abnormal FIT result.

ColoRectal Cancer Screening for Southern California Community Health Centers

CRC-HUB-SPOKE: A ColoRectal Cancer Screening Hub for Southern California Community Health Centers

Proportion of patients who complete one normal FIT with repeat FIT within12-14 months.

Proportion of age-eligible patients with clinic visit in measurement year up-to-date with screening (FIT or FOBT in prior 12 months, sigmoidoscopy in last 5 years, colonoscopy in last 10 years).

Proportion of patients with abnormal FIT who complete colonoscopy within 6 months

Proportion of patients who have FIT ordered as part of usual care or interventions who complete FIT within 12 months

Median time to colonoscopy completion after abnormal FIT

Proportion of patients with abnormal FIT with a) colonoscopy ordered; b) insurance approval completed; c) precolonoscopy visit scheduled; d) precolonoscopy visit completed; e) adequate bowel preparation at time of colonoscopy; f) treatment evaluation referral initiated and first visit completed if CRC found.

National Cancer Institute (NCI)

University of California, San Diego

Professor

All Drugs and Chemicals

Nicotine

Varenicline

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

Participants will receive NRT and Motivational Interviewing counseling

Motivational Interviewing; 8 weeks of counseling

Varenicline plus Motivational Interviewing counseling

Brief advice, one time during initial session

Varenicline without counseling

Kolawole S Okuyemi, MD,MPH

the purpose of the study is to see if varenicline in combination with motivational counseling helps homeless cigarette smokers quit smoking.

Despite significant declines in cigarette smoking rates among adults in the United States in the last few decades, smoking rates remain high among poor and underserved populations. One underserved group is the 4 million homeless persons in the US among whom cigarette smoking rate is an alarming 70% or more; these rates are 3 times higher than national average. Two of the three leading causes of death among homeless persons, heart disease and cancer are tobacco related.2, 3 Despite very high smoking prevalence and disease burden in this population smoking cessation research have not been extended to the homeless. Recent studies including data from our research team show a considerable degree of readiness to quit smoking by homeless smokers and that nicotine replacement therapy (NRT) plus counseling show promise. However, homeless persons face many challenges that may constitute barriers for them to adhere to smoking cessation treatments even if such treatments have been proven effective in the general population. In order to reduce smoking-related health disparities within this underserved population, it is critical that cessation interventions including strategies to improve treatment adherence be developed to include homeless smokers. The primary aim of this study is to assess the effects of adherence-focused motivational interviewing (MI) to help homeless persons quit smoking.

Recruitment and retention will be enhanced by use of bus passes for transportation, debit cards, attractive intervention materials, collaboration with homeless shelters, and advice from a community advisory board. If successful, this study will provide a model for how to overcome barriers to cancer prevention services among homeless persons. It will also provide the impetus for policy changes directed at increasing homeless persons' access to smoking cessation pharmacotherapy and treatment.

Improving Varenicline Adherence and Outcomes in Homeless Smokers

University of Minnesota

At the point of randomization the early group will receive increasingly intensive reminders to complete specific cancer screening tests.

Early Intervention

One year from the point of randomization patients will begin to receive increasingly intensive reminders to complete specific cancer screening tests.

Delayed intervention

Kevin Fiscella, MD, MPH

The purpose of this project is to improve cancer screening rates within practices serving low-income minority patients

This project is designed to implement and rigorously evaluate a cancer screening quality improvement project within a practice serving underserved patients. The project involves use of a patient registry coupled with patient reminders,recall and outreach.All unscreened patients will receive the benefit of this intervention, though some sooner than others for the purpose of evaluation.

Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities

American Cancer Society, Inc.

University of Rochester

Principal Investigator

This group is composed of health mediators, the people living in informal housing they support and stakeholders. The ECEMSo intervention will be implemented in this group

This group is composed of health mediators, the people living in informal housing they support and stakeholders. The ECEMSo intervention will not be implemented in this group.

This group is composed of health workers, social workers, the people living in informal housing they support and stakeholders. The ECEMSo intervention will be implemented in this group.

The ECEMSo intervention involves knowledge mobilization to facilitate the structuring of health mediation throughout French territory, and the development of a co-designed effective action plan to facilitate cancer screening uptake by people living in informal housing.

The action plan will, consider territorial specificities at the regional level. The ECEMSo project team will organize a seminar and three workshops. The aim of the seminar and workshops is to mobilize knowledge to facilitate i) the structuring of health mediation in the regions, and ii) the development of an action plan with health mediators and other stakeholders to foster organized cancer screenings uptake by underserved people. This action plan must match with the needs of people living in informal housing, and must be coordinated, suitable and feasible to implement, in terms of knowledge about people living in informal housing specificities and specific local collaborations

Knowledge mobilization to facilitate the structuring of health mediation

Judith Martin-Fernandez, PhD

Garance Perret

The investigators are conducting a longitudinal mixed-method intervention study with a multi-center, multi-case explanatory sequential design. The ECEMSo study aims to identify the impact of health mediation on fostering healthcare utilization, in particular organized cancer screening uptake, by underserved populations living in informal housing in France.

Health mediation may foster underserved populations' healthcare utilization. No study to date has demonstrated its effectiveness in an experimental context. The ECEMSo case study aims to identify the impact of health mediation on fostering healthcare utilization - in particular organized cancer screening uptake - by underserved populations living in informal housing in France.

Grounded in a theory-based framework, the ECEMSo case study is a longitudinal mixed-method intervention study with a multi-center, multi-case explanatory sequential design. The study population comprises various participant profiles including health mediators, health workers, social workers, people living in informal housing whom these professionals support, and other stakeholders concerned with underserved populations' health issues. Participants will be recruited in several French regions and divided into three mixed participant profile groups. In group 1, health mediation and the ECEMSo intervention will be implemented. This intervention comprises knowledge mobilization to facilitate the structuring of health mediation throughout France, and the development of an action plan to facilitate cancer screening uptake by people living in informal housing. In group 2, only health mediation will be implemented (i.e., no ECEMSo intervention). In group 3, neither health mediation nor the ECEMSo intervention will be implemented, but health and social workers will implement other health system navigation interventions.

Quantitative and qualitative data will be collected by interviewers through face-to-face questionnaires, interviews, observations, focus groups, and tracking tables of health mediation activities over six months. Data collection will be based on the health mediation conceptual framework.

longitudinal mixed-method intervention study with a multi-center, multi-case explanatory sequential design

Study of the Conditions of the Effects of Health Mediation on Underserved Population

Study of the Conditions of the Effects of Health Mediation on Underserved Populations' Healthcare Utilization

The difference in healthcare utilization by PLIH between groups 2 and group 3

The difference in organized cancer screening uptake (breast cancer, colorectal cancer, cervical cancer) between PLIH in group 1 and PLIH in group 2

The difference in organized cancer screening uptake (at 2 years since diagnosis for breast cancer and colorectal cancer, at 3 years since diagnosis for cervical cancer) between PLIH in group 1 and people living in informal housing in group 3

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ColoRectal Cancer Screening for Southern California Community Health Centers	NCT04941300	Colorectal Canc...	Mailed FIT Outr... Standardized na...	50 Years - 75 Years	University of California, San Diego
Improving Varenicline Adherence and Outcomes in Homeless Smokers	NCT00786149	Tobacco Use Ces...	Varenicline plu... Varenicline wit...	18 Years -	University of Minnesota
Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities	NCT00818857	Preventive Meas...	Early Intervent... Delayed interve...	40 Years - 75 Years	University of Rochester
Improving Varenicline Adherence and Outcomes in Homeless Smokers	NCT00786149	Tobacco Use Ces...	Varenicline plu... Varenicline wit...	18 Years -	University of Minnesota
Study of the Conditions of the Effects of Health Mediation on Underserved Population	NCT06180746	Mediation	Knowledge mobil...	18 Years - 99 Years	University Hospital, Bordeaux

Spots Global Cancer Trial Database for underserved populations