Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Syndrome

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

There is no intervention with this arm. Completion of the website is part of enrollment.

The intervention consists of participants receiving the services of a patient navigator to address individual barriers to adhering to the "personal prescription" for colon and rectal cancer screening.

There is no intervention in this arm. Patients diagnosed as positive for Lynch Syndrome use genetic counseling to discuss medical and family history and genetic risk of CRC, including genetic factors such as DNA mismatch repair genes, autosomal dominant inheritance, cancer risks associated with LS, screening recommendations, and genetic testing. There is no intervention. This is standard care.

Participants diagnosed positive for Lynch syndrome use genetic counseling as in Arm 3 and in addition receive the services of a patient navigator to address individual barriers to adhering to the CRC screening recommendations.

Patients are randomized to receive the assistance of a patient navigator to understand, obtain assistance with following the screening recommendations of the personal prescription given to them by the website survey.

Patient Navigator

Electra Paskett

This randomized clinical trial studies website access or genetic counseling with or without patient navigators on adherence to colorectal cancer screening recommendations in patients with newly diagnosed colorectal cancer and their first degree relatives. Websites for colorectal cancer prevention and genetic counseling may be effective methods to help people learn about cancer screening. Patient navigators may improve adherence to colorectal cancer screening recommendations. It is not yet known whether website access or genetic counseling is more effective with or without patient navigators.

PRIMARY OBJECTIVES:

I. Test the comparative-effectiveness of the interventions (i.e., website +/- navigator or genetic counseling +/- navigator) in a randomized controlled trial, using colorectal cancer (CRC) cases as the unit of randomization/analysis on adherence to individualized CRC screening recommendations.

SECONDARY OBJECTIVES:

I. Examine the cost effectiveness of the interventions, assessing the effect of the interventions on subgroups (i.e., Lynch syndrome positive vs. Lynch syndrome negative; probands vs. relatives; older vs. younger patients, etc), and barriers to adherence, as well as how the navigators resolve barriers.

II. Overscreening will be explored.

OUTLINE: Participants are assigned to 1 of 2 study components based on LS status. Within each component, participants are randomized to 1 of 2 arms.

COMPONENT #1 (Lynch Negative Proband and their first degree relatives (FDRs):

ARM I: Participants access a website to deliver a "personalized prescription for CRC prevention" based on age, Lynch Syndrome status, cancer history, age of 1st degree relative with CRC, and personal CRC screening history.

ARM II: Participants access a website as in Arm I and receive the services of a patient navigator to address individual barriers to adhering to the "personal prescription" within 1 month.

COMPONENT #2 (Lynch Positive Proband and their FDRs):

ARM III (Lynch positive proband): Participants use genetic counseling to discuss medical and family history and genetic risk of CRC, including genetic factors such as deoxyribonucleic acid (DNA) mismatch repair genes, autosomal dominant inheritance, cancer risks associated with LS, screening recommendations, and genetic testing.

ARM IV (Lynch positive proband): Participants use genetic counseling as in Arm III and receive the services of a patient navigator to address individual barriers to adhering to the CRC screening recommendations within 1 month.

After completion of study treatment, patients are followed up at 12-14 months.

Adherence to Colon Cancer Screening (ACCS)

Ohio Colorectal Cancer Prevention Initiative: Adherence to Colon Cancer Screening (ACCS) Project:Your Personal Prescription For Colorectal Cancer Screening.

For participants who are within the recommended guidelines, success would be defined as receiving no further screening. For those outside of the recommended guidelines, success would entail receiving a screening test. The outcome will combine medical record review and self-report by using medical record review when available and self-report otherwise. Evaluations will use a generalized estimating equations (GEE) approach with empirical sandwich variance estimators.

Analysis will consist of a cost analysis of the intervention incorporating project expenditures and both financial and non-financial costs incurred by the project participants. Financial benefits from the project will be incorporated into the cost analysis to produce a net cost of the interventions. These financial benefits will include expenditures for unnecessary or "overscreening" prevented by the interventions. The results of the net cost analysis will be combined with the outcome measures for screening interventions to establish the cost per guideline concordant screening.

Ohio State University Comprehensive Cancer Center

Principal Investigator

The control or lesser intervention group, will receive cancer screening information on a quarterly basis, with no facilitation of services.

The intervention group are those participants who were randomly assigned to receive facilitation of services in the form of patient navigation for the duration of the study.

The control group will receive cancer screening and health education materials on a quarterly basis but will not have access to patient navigation services.

cancer screening and health education

The intervention group will receive cancer education and faciliation of services in the form of patient navigation

facilitation of Services to improve cancer screening

Ana Natale-Pereira, MD, MPH

To reduce Cancer health care disparities that exists among minority Medicare beneficiaries and to demonstrate cost effectiveness of patient navigation in reducing the burden of cancer.

The Latino population is the fastest growing minority population in the United States . Cancer ranks as the second leading cause of death among Latinos in the United States (24%), second only to heart disease . This project will evaluate whether an innovative facilitation program (targeting cancers of the prostate, colon/rectum, breast, and cervix) will improve cancer outcomes among Latino Medicare beneficiaries in the city of Newark, New Jersey.

The overall aim of this project is to institute an innovative cancer care facilitation program for elderly Latinos in the city of Newark, NJ. The goal is to reduce the disparities observed in screening, time to diagnosis and treatment services, by utilizing a multidisciplinary team approach to health care, incorporating systems thinking methodology. Using the Multilevel Approach to Community Health (MATCH) planning model , the program will incorporate community outreach, education, and access to screening, and patient assistance in all aspects of the health care continuum. It will also include cultural and linguistic competency training for all those involved in the facilitation process. To accomplish this goal, we propose four objectives:

1. To establish a multidisciplinary team that will utilize a systems thinking approach to design and structure the delivery of cancer screening, diagnosis and treatment facilitation services.
2. To build a collaborative consortium between program partners to improve screening outcomes, that will encourage the utilization of services in the community.
3. To improve the delivery of cancer prevention and treatment facilitation by providing cultural and linguistic competency training to the multidisciplinary team, providers, and the community.
4. To demonstrate the effectiveness of the intervention in reducing the burden of cancer, by increasing screening rates, improving time to diagnosis and delivery of treatment services, patient satisfaction, and appropriate use of Medicare services.

Addressing Disparities in Cancer Care for Latino Medicare Beneficiaries

Centers for Medicare and Medicaid Services

University of Medicine and Dentistry of New Jersey

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Uterine Cervical Neoplasms

Breast Neoplasms

Prostatic Neoplasms

Lung Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Rectal Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Patient Navigator (PN) + Educational Materials + Annual Questionnaires

Educational Materials + Exit Questionnaire

Intervention Group:

Cancer Screening Assessment (CSA) questionnaire 45-60 minutes annually for 4 years + Exit Questionnaire at end of study.

Comparison Group:

Exit Questionnaire only.

Questionnaire

Staff member, called patient navigator (PN), who assist with medical care and/or screenings, questionnaires.

Patient Navigator (PN)

Isabel Torres, DRPH,MPH

The goal of this behavioral research study is to improve the use of cancer prevention services, increase early detection, and treatment of cancer. A secondary outcome of this demonstration project proposes that a structured patient navigator (PN) will reduce the cost of Medicare services.

Screening Questionnaire:

Before you can start on this study, you will answer a 20 minute Triage questionnaire. The questionnaire will ask you if you have had cancer, what type of cancer, and when you were last treated.

Cancer-Screening Groups and Treatment Groups:

Once you answer the Triage questionnaire and if you are found to be eligible to take part in this study, you will be placed in the Cancer Screening Group or the Treatment Group based on your answers to the Triage questionnaire.

If you have not been treated for cancer in the past or if it has been more than 5 years since you were last treated, you will be in the Cancer Screening Group and you will complete the screening Cancer Screening Assessment (CSA). The CSA will ask you about cancer screenings, lifestyle, and other health related items. The questionnaire should take about a total of 45-60 minutes to complete.

If you have been treated for cancer in the past 5 years, you will be in the Treatment Group. The CSA will ask you about cancer screenings, cancer treatment, and other health related items. The questionnaire should take about a total of 45-60 minutes to complete.

After completion of the Cancer Screening Assessment (CSA) for either the Cancer Screening Group or the Treatment Group, you will complete a CSA addendum questionnaire. This CSA addendum questionnaire will ask you about barriers and factors that may influence your health related decisions. The questionnaire should take 15-20 minutes to complete.

Intervention and Comparison Groups:

Participants in either the cancer-screening group or the treatment group will be randomly assigned (as in the flip of a coin) to one of 2 additional groups, the "Intervention group" or the "Comparison" group. You will have an equal chance of being in either group.

If you are in the Intervention Group, you will work with a staff member, called a patient navigator (PN), who will assist with medical care and/or screenings (intervention group). For example, the staff member may help schedule screening appointments, medical care appointments, or any other necessary assistance to meet health care needs. The PN will be responsible for recording information about your care and any cancer treatment, should that be necessary.

You will complete a CSA questionnaire 1 time a year for up to 4 years. A staff member will contact you by phone to set up an appointment to give you the CSA questionnaires. All questionnaires will be completed at a time and place that you and the study staff agree upon. For example, the study staff may meet you at a community center, independent-living center, or another agreed upon location. The questionnaire should take about 45-60 minutes to complete.

If you are in the Comparison Group, you will not work with a staff member and you will not complete any additional questionnaires during the 4 years on study.

Both the intervention group and the comparison group will receive educational materials.

Exit Questionnaire:

About 4 years after you join the study, you will be contacted by a staff member and you will set up an exit questionnaire meeting. This questionnaire will be completed at a time and place that you and the staff member agree upon. This questionnaire will contain similar questions to those you have been answering since your participation in the study. The questionnaire will take about 45-60 minutes to complete.

Length of Study:

You will be considered off-study after 4 years.

This is an investigational study. Up to 11,964 participants will take part in this study. A total of 2,812 will be enrolled at M. D. Anderson.

Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities

Cancer Prevention and Treatment Demonstration for Hispanic Medicare Eligible Beneficiaries - CMS

M.D. Anderson Cancer Center

People in this arm receive the Intervention of a Patient Navigator

People in this arm receive just the usual care of colorectal cancer screening

Insured people receive firstly a letter to inform them that a patient navigator is available to navigate them during the colorectal screening steps. A free telephone number and the navigator schedule is given. After a minimum of one week the patient navigator begins the telephone outreach.

Patient Navigation

Guy Launoy, Pr

Variations in participation to the colorectal cancer screening seems to reveal social and geographical inequalities. Our study will investigate whether patient navigation could increase the participation to the colorectal cancer screening and in the same time, reduce the social inequalities.

Study of Patient Navigation to Reduce Social Inequalities

The Patient Navigator to Reduce Social Inequalities. A French Interventional Trial in Public Health

The participation rate to the colorectal cancer screening will be compared between privileged and deprived geographical areas for which the socio-economic status is measured with the Townsend index.

We will assess the mean cost to navigate one person and compared it to a non navigate person. We will measure the cost effectiveness of the intervention in order to have the cost of the arising of 1% of the participation rate.

Evaluation of cognitive, behavioural, emotional mechanisms influencing the colorectal screening participation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adherence to Colon Cancer Screening (ACCS)	NCT02112747	Colon Cancer Rectal Cancer	Patient Navigat...	25 Years - 75 Years	Ohio State University Comprehensive Cancer Center
Addressing Disparities in Cancer Care for Latino Medicare Beneficiaries	NCT00385866	Cancer	cancer screenin... facilitation of...	-	Rutgers, The State University of New Jersey
Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities	NCT00453661	Breast Cancer Cervical Cancer Prostate Cancer Colorectal Canc... Lung Cancer	Questionnaire Patient Navigat...	40 Years -	M.D. Anderson Cancer Center
Adherence to Colon Cancer Screening (ACCS)	NCT02112747	Colon Cancer Rectal Cancer	Patient Navigat...	25 Years - 75 Years	Ohio State University Comprehensive Cancer Center
Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities	NCT00453661	Breast Cancer Cervical Cancer Prostate Cancer Colorectal Canc... Lung Cancer	Questionnaire Patient Navigat...	40 Years -	M.D. Anderson Cancer Center
Study of Patient Navigation to Reduce Social Inequalities	NCT01555450	Colorectal Canc...	Patient Navigat...	50 Years - 74 Years	Institut National de la Santé Et de la Recherche Médicale, France
Study of Patient Navigation to Reduce Social Inequalities	NCT01555450	Colorectal Canc...	Patient Navigat...	50 Years - 74 Years	Institut National de la Santé Et de la Recherche Médicale, France

Spots Global Cancer Trial Database for patient navigator