Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Patient navigators provided culturally sensitive support and guidance to Latina women who presented radiologic abnormalities categorized as BI-RADS 3, 4 and 5. Patient Navigators also collected clinical information from the patients' medical charts.

A convenience sampling approach was used to recruit non navigated Latinas. Eligibility criteria targeted self-identified Latinas at community-based health clinics, aged \> 18 years with an abnormal breast screening mammogram resulting in BI-RADS 3, 4 or 5. Controls were chosen by determining eligibility consecutively backwards from the study start date.

Patient Navigated Latinas

Non Navigated Latinas

Amelie G Ramirez, DrPH

The purpose of this study is to assess the efficacy of a "patient navigator" program that uses a trained community lay health worker to assist Hispanic patients in utilizing cancer care services. This study is a two part study. The first part of the study consists of a retrospective data collection procedure called "baseline clinical chart audit" of 50 Hispanic women over 18 years of age who have had a mammography abnormality classified as BI-RADS 3, 4 or 5. These data will be drawn from the study clinic's existing records and will serve as baseline data for subjects recruited during the course of the study. The second part of the study, the intervention group, involves the recruitment of 50 low-income, Hispanic women who receive abnormal breast cancer screening results (also classified as BI-RADS 3, 4 or 5) from screening services at local community health clinics. Participants will have significantly higher compliance rates and significantly shorter time lags and between an abnormal screening result, and confirmatory screening tests and commencement of treatment, compared to our baseline. The investigators expect at least a 12% increase in after-screening compliance rate and a 25% reduction in time lags in the treatment group, in relation to the pre-intervention baseline assessment.

Breast cancer is the leading cause of cancer-related deaths in Latinas, chiefly because of later diagnosis. The time from screening to diagnosis is critical to optimizing cancer care, yet the efficacy of navigation in reducing it is insufficiently documented. Here the investigators evaluate a culturally sensitive patient navigation program to reduce the time to diagnosis and increase the proportions of women diagnosed within 30 days and 60 days. METHODS. The investigators analyzed 425 Latinas who had Breast Imaging Reporting and Data System (BI-RADS) radiologic abnormalities categorized as BI-RADS-3, BI-RADS-4, or BI-RADS-5 from July 2008 to January 2011. There were 217 women in the navigated group and 208 women in the control group. Women were navigated by locally trained navigators or were not navigated (data for this group were abstracted from charts). The Kaplan-Meier method, Cox proportional hazards regression, and logistic regression were used to determine differences between groups. RESULTS. The time to diagnosis was shorter in the navigated group (mean, 32.5 days vs 44.6 days in the control group; hazard ratio, 1.32; P ¼ .007). Stratified analysis revealed that navigation significantly shortened the time to diagnosis among women who had BI-RADS-3 radiologic abnormalities (mean, 21.3 days vs 63.0 days; hazard ratio, 2.42; P \< .001) but not among those who had BI-RADS-4 or BI-RADS-5 radiologic abnormalities (mean, 37.6 days vs 36.9 days; hazard ratio, 0.98; P ¼ .989). Timely diagnosis occurred more frequently among navigated Latinas (within 30 days: 67.3% vs 57.7%; P ¼ .045; within 60 days: 86.2% vs 78.4%; P ¼ .023). This was driven by the BI-RADS-3 strata (within 30 days: 83.6% vs 50%; P \< .001; within 60 days: 94.5% vs 67.2%; P \< .001). A lack of missed appointments was associated with timely diagnosis. CONCLUSIONS. Patient-centered navigation to assist Latina women with abnormal screening mammograms appeared to reduced the time to diagnosis and increase rates of timely diagnosis overall. However, in stratified analyses, only navigated Latinas with an initial BI-RADS-3 screen benefited, probably because of a reduction in missed diagnostic appointments in this group.

Redes II National Patient Navigator Intervention Study

Redes en Acción: National Patient Navigator Intervention Study

Number of days from date of index screening abnormality to definitive diagnosis and the proportion achieving timely diagnosis (within 30 days or 60 days of screening).

Number of days from date of definitive diagnosis to initiation of treatment and the proportion achieving timely treatment (within 30 or 60 days of diagnosis)

Relationship of # of reported barriers by navigated women and relationship of it to T0-T1 and T1-T2

Patient satisfaction with navigation provided as measured by Patient Satisfaction scale

Patient mental health status pre- and post-navigation

The Brooklyn Hospital Center

University of Miami Sylvester Comprehensive Cancer Center

The University of Texas Health Science Center, Houston

University of California, San Francisco

University of California, San Diego

The University of Texas Health Science Center at San Antonio

Heart and Blood Diseases

Heart Failure

Heart Diseases

Patients admitted to University of Colorado Hospital with at least one of the following diagnoses:

* Heart Failure
* COPD
* Cancer

Bedside nurses who provide care at the inpatient level for the following diseases:

* Heart Failure
* COPD
* Cancer

The storytelling intervention consists of an audio-recorded interview with each patient participant prompted the participant to share their story with questions such as: tell me about your illness, tell me how your illness has affected your emotions, relationships, and spirituality. The interview transcripts will be used to co-create a 1 page patient story using these criteria:1) written in the first person; 2) nonjudgmental; 3) captures the participant's voice; 4) accurately reflects content of the interview; and 5) non-labeling. Once the story has been approved by the participant, I will upload it to the EHR.

Storytelling Intervention for Patient Participants

Once the patient's story is uploaded to the EHR, automatic alerts will be sent to the participant's EHR-assigned nurses. For usability testing, nurse participants will 1) provide content expertise of the workflow processes, and 2) put the storytelling intervention through in-house usability testing to check the "strength" of EHR features and user-friendliness. Data will be collected with exit interviews and completion of a questionnaire: the System Usability Scale which asks them to rank their satisfaction with specific elements such as: how the story is labeled and presented in the EHR, any technical navigation EHR difficulties, and use of the material.

Storytelling Intervention for Nurse Participants

The purpose of this research is to develop patient-centered palliative care interventions to improve patient-provider communication and Quality of Life (QoL) of ethnic and racial minority patients living with life-limiting illnesses. Eliciting personal experiences is an effective way for patients to communicate their cultural values and beliefs. This study will assess how to integrate the patients' personal experience narratives into the electronic health record (EHR). The primary hypothesis is that the implementation of a patient-centered intervention to elicit personal experiences that are included in the EHR will improve patient-provider communication and patients' QoL.

Racial and ethnic minority patients with a Life Limiting Illnes (LLI) in the United States are underserved in many ways, including quality of palliative care. Specific disparities have been reported in palliative care for minority patients, including sub-optimal patient-provider communication and resulting lower QoL. A potential approach to improve communication is to elicit patients' personal narratives that address their cultural or spiritual values and beliefs, and include them in the EHR. The objective of this observational study is to assess the feasibility and efficacy of a palliative care nursing intervention designed to 1) identify barriers and facilitators for eliciting and recording relevant narratives from the perspectives of the key stakeholders: minority patients with LLI; 2) to conduct usability testing, applying a user-system-environment evaluation process to determine essential requirements for integration of the patient-centered narratives into the EHR; and 3) identify barriers and facilitators of integration of the patient's narrative into daily workflow from the perspectives of key stakeholders: acute care bedside nurse.

Personalized Experiences to Inform Improved Communication for Minorities With Life Limiting Illness

This study will utilize an observational design to define and refine the storytelling intervention, seeking input from the key stakeholders: providers (acute care bedside nurses).The SUS scale is a 10 item Likert scale which gives a global view of subjective assessment of usability with five item responses options from strongly agree to strongly disagree. SUS yields a single number representing a composite measure of the overall usability of the system being studied. Note that scores for individual items are not meaningful on their own. To calculate the SUS score, first sum the score contributions from each item. Each item's score contribution will range from 0 to 4. For items 1,3,5,7, and 9, the score contribution is the scale position minus 1. For items 2,4,6,8, and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall value of the SUS, with the higher the number, the better the outcome.

Using an observational design, this measure (exit interviews) were completed with 20 inpatient participants and 18 nurse participants. The qualitative data from the interviews were used to define and refine the storytelling intervention. The data collected from the exit interview is qualitative in nature and therefore does not have a numerical value.

National Institute of Nursing Research (NINR)

University of Colorado, Denver

Patients admitted to University of Colorado Hospital with at least one of the following diagnoses:

* Heart Failure
* COPD
* Cancer

Storytelling Intervention for Patient Participants: The storytelling intervention consists of an audio-recorded interview with each patient participant prompted the participant to share their story with questions such as: tell me about your illness, tell me how your illness has affected your emotions, relationships, and spirituality. The interview transcripts will be used to co-create a 1 page patient story using these criteria:1) written in the first person; 2) nonjudgmental; 3) captures the participant's voice; 4) accurately reflects content of the interview; and 5) non-labeling. Once the story has been approved by the participant, I will upload it to the EHR.

Inpatient Participants

Bedside nurses who provide care at the inpatient level for the following diseases:

* Heart Failure
* COPD
* Cancer

Storytelling Intervention for Nurse Participants: Once the patient's story is uploaded to the EHR, automatic alerts will be sent to the participant's EHR-assigned nurses. For usability testing, nurse participants will 1) provide content expertise of the workflow processes, and 2) put the storytelling intervention through in-house usability testing to check the "strength" of EHR features and user-friendliness. Data will be collected with exit interviews and completion of a questionnaire: the System Usability Scale which asks them to rank their satisfaction with specific elements such as: how the story is labeled and presented in the EHR, any technical navigation EHR difficulties, and use of the material.

Nurse Participants

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Heather Coats, PhD, APRN-BC, PI

Number of Completed Exit Interviews From Patients on Feasibility of Their Use of Their Narrative Integrated Into EHR

Patient Participants did not complete this secondary measure. This was only the nurse participants completing the NIH System Usability Scale

Usability Assessment Via the System Usability Scale(SUS), Range of 0 to 100, With Higher Number Representing a Better Outcome SUS Scores Have a Range of 0 to 100, the Higher the Number Represents a Better Outcome.

Overall Study

Behaviors and Mental Disorders

Anxiety Disorders

Depression

Depressive Disorder

Behavioral Symptoms

Female Sexual Function Index (FSFI), Hospital Anxiety and Depression Scale (HADS), and a demographic questionnaire given to underserved and minority women with a gynecologic cancer or premalignant condition.

Surveys -- Female Sexual Function Index (FSFI), the Hospital Anxiety and Depression Scale (HADS), and a demographic questionnaire completed at time of clinic appointment, taking about 20 minutes.

Surveys

Lois M. Ramondetta, MD

Objectives:

* Assess the prevalence and severity of depression and anxiety in underserved and minority women seen in the gynecologic oncology clinic at Lyndon Baines Johnson General Hospital.
* Assess the prevalence and severity of sexual dysfunction in this patient population.

The instruments used in this study will be completed at one timepoint, by those women who choose to participate, anonymously. The questionnaires will be preceded with a statement informing the patient that by completing the study questionnaires she is consenting to study participation. No patient names or medical record numbers will be documented.

When a patient checks in for her clinic appointment, she will receive a packet of study materials consisting of a cover letter describing the study objectives, the Female Sexual Function Index, the Hospital Anxiety and Depression Scale, and a demographic questionnaire. The tools used in this study will be available in both English and Spanish.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Redes II National Patient Navigator Intervention Study	NCT02269033	Breast Cancer	Patient Navigat... Non Navigated L...	18 Years -	The University of Texas Health Science Center at San Antonio
Personalized Experiences to Inform Improved Communication for Minorities With Life Limiting Illness	NCT03391115	COPD Heart Failure Cancer	Storytelling In... Storytelling In...	18 Years -	University of Colorado, Denver
Assessment of Sexual Dysfunction, Depression and Anxiety in Underserved, Minority Gynecologic Cancers Patients	NCT01031602	Gynecologic Can...	Surveys	-	M.D. Anderson Cancer Center
Redes II National Patient Navigator Intervention Study	NCT02269033	Breast Cancer	Patient Navigat... Non Navigated L...	18 Years -	The University of Texas Health Science Center at San Antonio

Spots Global Cancer Trial Database for underserved

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

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