Participants in the intervention group will receive 3 components: 1) a bilingual, culturally tailored clinical trial educational video, 2) a low literacy booklet, and 3) support from a patient navigator to empower cancer patients to make informed decisions about cancer clinical trial participation by increasing awareness of clinical trials and MCC services, positive attitudes and intentions to consider clinical trials as an appropriate treatment option for cancer.

Participants in the usual care control group will receive a general clinical trial fact sheet.

Bilingual, culturally tailored educational video, low literacy booklet, and support from a patient navigator to empower new cancer patients to make informed decisions about cancer clinical trial participation.

Clinical Trial Educational Video

General Clinical Trial fact sheet with usual care information regarding Clinical Trials.

Clinical Trial Fact Sheet

A bilingual low-literacy booklet with educational content about clinical trials.

Low literacy booklet

Support will be provided by a patient navigator to empower cancer patients to make an informed decision about cancer clinical trial participation by increasing awareness of clinical trials and MCC services, positive attitudes, and intentions to consider clinical trials as an appropriate treatment option for cancer.

Navigator

Vivian Cortez, MS

Anna Moreno

Amelie G Ramirez, DrPH, MPH

Patricia Chalela, DrPH

Patricia Chalela, DrPH, MPH

The goal of this study is to develop and pilot test a multi-communication approach to improve informed decision-making about cancer Clinical Trials (CTs) participation by increasing awareness of CTs and Mays Cancer Center (MCC) services (treatment care capacities, reputation and resources), positive attitudes towards CTs, self-efficacy and intentions to consider CTs as an appropriate treatment option for cancer (intention to participate) among patients attending the MCC (clinic-based setting) and the general public in selected Bexar County areas (community-based settings).

The proposed two-year study involves a randomized controlled educational trial featuring a 2-group parallel cohort design with random assignment of 400 cancer patients from the MCC to the intervention or usual care control group. Intervention participants will receive 3 components: 1) a bilingual culturally relevant educational video, 2) a low-literacy booklet and 3) support from a patient navigator to empower new cancer patients to make informed decisions about cancer CT participation by increasing awareness of clinical trials and MCC services, positive attitudes and intentions to consider CTs as an appropriate treatment option for cancer. The usual care control group will receive a general CT fact sheet.

The community setting will involve a community awareness campaign including 400 community members, with 3 components: 1) an educational session delivered via PowerPoint presentation or flip chart, 2) a low-literacy booklet, and 3) support from a community health educator to raise awareness, positive attitudes and intentions to consider CTs as an appropriate treatment option for cancer and promote the MCC services among community members in Bexar County.

Improving Informed Decision Making for Cancer Clinical Trial Participation

The percentage of patients who increased intentions to participate in a CT after the intervention compared with baseline.

The percentage of patients who improved knowledge/awareness about clinical trials after the intervention compared with baseline.

The percentage of patients who improve their attitudes towards clinical trial participation after the intervention compared with baseline.

The percentage of patients who actually participate, or enroll in a clinical trial if they meet the eligibility criteria.

Genentech, Inc.

The University of Texas Health Science Center at San Antonio

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Skin and Connective Tissue Diseases

Uterine Cervical Neoplasms

Breast Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Assigning a patient navigator to patients with abnormal breast and cervical cancer screening results at one of 6 affiliated community health centers

patient Navigation

Karen M Freund, MD, MPH

Tracy Battaglia, MD, MPH

The Boston University Medical Center, funded by the National Cancer Institutes will train health workers at six of its affiliated Community Health Centers to guide patients through the cancer care system. The project will help to teach patients how to communicate more effectively with their health care team in order to understand the treatment options available to them. Although not widely available, it is believed patient navigation programs are beneficial.

This research study will evaluate how well this tool works, especially among those who experience disparities in health care. The goal is to determine if having a trained navigator shortens the time between an abnormal test result and a definitive diagnosis and between a definitive diagnosis and completion of treatment for breast and Cervical cancer patients. The project also will evaluate whether navigation improves the ability to communicate with the doctor, satisfaction with patient's care and quality of life.

Racial and ethnic minority groups and low-income persons experience significantly higher cancer mortality rates than other Americans. These disparities are due to at least two factors: (1) delays in follow-up of abnormal cancer screening results and (2) suboptimal management of diagnosed cancer. Patient navigation represents a promising means for addressing disparities by improving cancer related management for minority and other underserved populations. However, patient navigation for cancer has yet to be evaluated through a well-designed randomized controlled trial. Furthermore, patient navigation is likely to prove most effective and sustainable when it is integrated into primary care and helps patients be more active in their care. This combination of patient empowerment and engagement is referred to as "activation." The aim of this project is to evaluate the effectiveness and costs of such a program in a rigorous manner so that the results can be generalized and the program can be widely disseminated and implemented. We will develop, implement, and evaluate a primary care-based, patient navigation-activation program using specially-trained patient Navigators who work within one of the six affiliated Community Health Centers. We propose to investigate the effect of this intervention on timing and quality of cancer-related care. Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation, and total costs. Project findings will inform national policy regarding patient navigation for cancer.

Patient Navigation in the Safety Net:CONNECTeDD

Boston Medical Center

Assistant Professor

Patient navigator services provided as part of survivorship care plan

Patient Navigation services will be provided to try to eliminate barriers in pursuing survivorship surveillance

Minh Tam Truong, MD

This study seeks to enroll patients receiving a Survivorship Care Plan following curative therapy for cancer. Participants will be randomly assigned to receive usual care or to be followed by a Patient Navigator as part of their Survivorship Care Plan.

This study seeks to enroll patients receiving a Survivorship Care Plan following curative therapy for cancer. Participants will be randomly assigned to receive usual care or to be followed by a Patient Navigator as part of their Survivorship Care Plan.

Study participation for all participants will be for up to 9 months, with study visits approximately every 3 months, based on standard clinical follow-up. All participants will be administered quality of life surveys by a Clinical Research Associate at study entry, mid-study (approximately 3-6 months) and at study completion.

The following factors will be compared between arms:

* Missed/kept appointments
* Use of urgent/emergent care
* Quality of Life in relation to survivorship care
* Participants lost to care

Patient Navigation in Cancer Survivorship at a Safety Net Institution

Patient Navigation as Part of the Cancer Survivorship Care Plan at a Safety Net Institution

The research team will document the number of cancer care appointments scheduled and of those, how many appointments were missed (obtained by medical record and by patient report in case a visit was outside of study institution).

The research team will document the number of urgent/emergent care visits attended within the study period of 9 months (obtained by medical record and by patient report in case a visit was outside of study institution).

Participants will rate their feelings about 39 specific cancer needs on a 5 point scale from "Not a Problem" to "Very Severe Problem" using the Cancer Needs Distress Inventory (CaNDI) tool. Total scores can range from 39 to 195. Lower scores are associated with less cancer related distress.

Participants will rate their understanding about 16 specific aspects of survivorship care on a 4 point scale from "Strongly Disagree" to "Strongly Agree" using the Preparing for Life as a New Survivor (PLANS) Scale. Total scores can range from 16 to 48. Lower scores are associated with less understanding of the survivorship care process.

The research team will document the number of participants lost to care, based on consecutive missed cancer care visits.

Harvard Pilgrim Health Care

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Navigation through the cancer care system is the intervention

Cancer patient receives standard of care.

Cancer patients are randomly assigned to receive standard of care or the help of a trained person to navigated them through the cancer care system

Navigation

Cancer patients receive standard of care for their cancer treatment

Standard of Care

Kevin Fiscella, M.D., MPH

The University of Rochester, Department of Family Medicine, funded by the National Cancer Institute will train community health workers to guide patients through the cancer care system. The project will help to teach patients how to communicate more effectively with their health care team in order to understand the treatment options available to them. Although not widely available, it is believed patient navigation programs are beneficial.

This research study will evaluate how well this tool works, especially among those who experience disparities in health care. The goal is to determine if having a trained navigator shortens the time between an abnormal test result and a definitive diagnosis and between a definitive diagnosis and completion of treatment for breast and colorectal cancer patients. The project also will evaluate whether navigation improves the ability to communicate with the doctor, patient satisfaction with care and quality of life.

Racial and ethnic minority groups and low-income persons experience significantly higher cancer mortality rates than other Americans. These disparities are due to at least two factors: (1) delays in follow-up of abnormal cancer screening results and (2) suboptimal management of diagnosed cancer. Patient navigation represents a promising means for addressing disparities by improving cancer related management for minority and other underserved populations. However, patient navigation for cancer has yet to be evaluated through a well-designed randomized controlled trial. Furthermore, patient navigation is likely to prove most effective and sustainable when it is integrated into primary care and helps patients be more active in their care. This combination of patient empowerment and enablement is referred to as "activation." The aim of this project is to evaluate the effectiveness and costs of such a program in a rigorous manner so that the results can be generalized and the program can be widely disseminated and implemented. we will develop, implement, and evaluate a primary care-based, patient navigation-activation program using specially-trained community health workers (CHWs). We propose to investigate the effect of this intervention on timing and quality of cancer-related care. Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation and total costs. Project findings will inform national policy regarding patient navigation for cancer.

Trial of Patient Navigation-Activation

RCT of Primary Care-based Patient Navigation-Activation

National Cancer Institute (NCI)

University of Rochester

Kevin Fiscella M.D. MPH

Behaviors and Mental Disorders

Mental Disorders

Problem Behavior

Psychotic Disorders

Behavioral Symptoms

experimental group: case manager care combined cancer nurse navigator care

control group: only case manager care(usual care)

oncology case manager care combined with cancer nurse navigator care

cancer nurse navigator care

case manager care

hsiu-ju Chang, PhD

Cancer patients will be recruited from the Taipei Cancer Center of Taipei Medical University. This study was divided into two phases. The first phase adopted cross-sectional study design with questionnaires to analyze the potential predictors of depressive symptoms among cancer patients. The second stage was adopted experimental study design to explore the effectiveness of nurse navigators in cancer care.

The first phase analyze the potential predictors include the following: socio-demographic characteristics, disease characteristics, lifestyle, perceived benefits, cancer patient' experience with medical service, emotional distress, anxiety, and demoralization.

The second phase will be experimental study.Thus, subjects were randomly sampled and divided into 2 groups: experimental group and control group. Subjects in the experimental group will receive oncology case manager care combined with cancer nurse navigator care, while subjects in the control group will be designed as regular care, which only care with cancer case managers. Both groups will receive long-term follow-up analysis (pre-intervention, post-intervention - 3 months, and 6 months). Outcome measures include the following: perceived benefits, emotional distress, depression and anxiety, demoralization, cancer patient' experience with medical service, and medical report indicators (retention rate, completion rate, survival rate, mortality rate, untreated cancer within 3 months).

Eligible patient were randomly assigned by the computer random number generator to either intervention or control group. Several methods were used to maintain the treatment blindly, including segregation of assessment and treatment staff and instructions to patients to avoid discussion of treatment assignment with the independent evaluators.

The Effectiveness of Nurse Navigators in Cancer Care

Questionnaires to measure self-efficacy collected at three time points (baseline, 3th month, and 6th month). Evaluate the effectiveness of interventions in PBS at three time points.

Questionnaires to measure patient' experience with medical service collected at three time points (baseline, 3th month, and 6th month). Evaluate the effectiveness of interventions in PACIC at three time points.

Questionnaires to measure emotional distress and psychological problems collected at three time points (baseline, 3th month, and 6th month). Evaluate the effectiveness of interventions in DT at three time points.

Questionnaires to measure anxiety and depression collected at three time points (baseline, 3th month, and 6th month). Evaluate the effectiveness of interventions in HADS at three time points.

Questionnaires to measure demoralization collected at three time points (baseline, 3th month, and 6th month). Evaluate the effectiveness of interventions in HADS at three time points.

Medical report indicators of the retention rate collected at 6th month

Medical report indicators of the completion rate collected at 6th month

Medical report indicators of the survival rate collected at 6th month

Medical report indicators of the mortality rate collected at 6th month

Medical report indicators of the untreated rate of cancer within 3 months collected at 6th month

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Improving Informed Decision Making for Cancer Clinical Trial Participation	NCT03820687	Educational Pro...	Clinical Trial ... Clinical Trial ... Low literacy bo... Navigator	18 Years -	The University of Texas Health Science Center at San Antonio
Patient Navigation in the Safety Net:CONNECTeDD	NCT00613275	Breast Cancer Cervical Cancer	patient Navigat...	18 Years -	Boston Medical Center
Improving Informed Decision Making for Cancer Clinical Trial Participation	NCT03820687	Educational Pro...	Clinical Trial ... Clinical Trial ... Low literacy bo... Navigator	18 Years -	The University of Texas Health Science Center at San Antonio
Patient Navigation in Cancer Survivorship at a Safety Net Institution	NCT03271099	Cancer	Navigator	18 Years -	Boston Medical Center
Trial of Patient Navigation-Activation	NCT00496678	Breast Cancer Colorectal Canc...	Navigation Standard of Car...	18 Years -	University of Rochester
Patient Navigation in the Safety Net:CONNECTeDD	NCT00613275	Breast Cancer Cervical Cancer	patient Navigat...	18 Years -	Boston Medical Center
The Effectiveness of Nurse Navigators in Cancer Care	NCT05537870	Neoplasms Nurse-Patient R... Psychiatric Dis...	cancer nurse na... case manager ca...	20 Years - 100 Years	Taipei Medical University

Spots Global Cancer Trial Database for navigator

Every month we try and update this database with for navigator 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 navigator

Every month we try and update this database with for navigator 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 navigator 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.