Symptoms and General Pathology

All Conditions

Colonic Polyps

Polyps

Pathological Conditions, Anatomical

Intestinal Polyps

Approximately 35 endoscopists whom are certified to perform colonoscopies on FIT-positive patients in the Dutch population screening program

Colonoscopies on FIT-positive patients in the Dutch population screening program

Olympus colonoscopes with Narrow Band Imaging

3-monthly or no 3-monthly feedback on results of optical diagnosis

Feedback

Evelien Dekker, Prof. dr.

In this study, Dutch gastroenterologists who are certified for performing colonoscopies on FIT-positive patients in the Dutch population screening program are trained in optical diagnosis with validated methods. After this training, an ex- and in-vivo test phase leads to "accreditation" and endoscopists will be observed in their optical diagnosis for 1 year. During this year, half of the endoscopists will be randomized towards 3-monthly feedback and the other half will receive feedback on their results after 1 year. The endoscopic prediction of endoscopists on polyp histology will be compared to histopathological outcome.

Through the recently started nationwide bowel cancer screening programme in the Netherlands, an extra 70.000 colonoscopies are annually performed. In current practice, all resected colonic lesions are histopathologically analysed. Even diminutive polyps, which rarely harbour cancer or advanced histological features. If endoscopists are able to accurately differentiate between neoplastic and non-neoplastic lesions during colonoscopy, practice could become more efficient and costeffective. This strategy is called optical diagnosis and two clinical practice strategies have been proposed by the American Society of Gastroenterologists (ASGE). First, diminutive polyps could be resected and discarded if \>90% of the surveillance intervals predicted on optical diagnosis correlate with the surveillance intervals after histopathological validation (if assessed with high confidence). Second, hyperplastic polyps in the rectosigmoid could be left in situ if endoscopists are able to confidently predict neoplastic histology of diminutive colorectal polyps with a negative predictive value (NPV) of ≥90%.

The accuracy of white light colonoscopy is not acceptable for daily practice (59%-84%), but narrow band imaging (NBI) allows higher accuracies up to 98% and it was demonstrated that experienced endoscopists could reach a NPV of ≥90% for diminutive colorectal lesions. However, recent research shows that community gastroenterologists are not able to meet the quality thresholds proposed by the ASGE. Before this strategy could be safely applied in daily practice, community gastroenterologists should be able to meet thresholds as well.

In this study, Dutch gastroenterologists who are certified for performing colonoscopies on FIT-positive patients in the Dutch population screening program, are trained in optical diagnosis with validated methods. After training, an ex- and in-vivo test phase leads to "accreditation" and endoscopists will be observed in their optical diagnosis for 1 year. During this year, half of the endoscopists will be randomized towards 3-monthly feedback and the other half will receive feedback on their results after 1 year. The endoscopic prediction of endoscopists on polyp histology will be compared to histopathological outcome.

Implementation of Optical Diagnosis for Diminutive Polyps Amongst Endoscopists: Training and Long-term Quality Assurance

Implementation of Optical Diagnosis for Diminutive Polyps Amongst Accredited Endoscopists for the Dutch Bowel Cancer Screening Program: Training and Long-term Quality Assurance

Dutch Digestive Diseases Foundation

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

MD, PhD

Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Subjects with pancreatic carcinoma who joined the interview group.

Subjects with pancreatic carcinoma who joined the user testing group

Black subjects with pancreatic cancer will provide insight on their experience discussing clinical trials and preferences for communicating clinical trial information

semistructured interviews

Black subjects with pancreatic cancer will provide feedback on mHealth app prototype.

feedback

Lori Stravers

Brent Henderson

Jen Jen Yeh, MD

Christian Campbell

Ugwuji Maduekwe, MD, MMSc, MPH

Jen J Yeh, MD

To develop a culturally tailored informational mobile application and test whether it will increase participation among Black pancreatic cancer subjects in clinical trial discussions with their care team.

This project aims to identify and address barriers to enrollment of Black subjects in pancreatic cancer clinical trials using a culturally informed mobile health application to promote participation.

The clinical trial education and communication needs of Black people with pancreatic cancer will be determined. A new mHealth application for clinical trial education and communication tailored to subject needs will be developed. It was hypothesized that a culturally tailored informational mobile application will increase the participation of Black subjects in clinical trial discussions with their care team among the target population.

This study focuses on Black pancreatic cancer subjects, who experience higher mortality rates and lower clinical trial participation than White subjects. Research shows that the disparity between clinical trial participation is in part due to inequitable recruitment practices. This study will use mobile application technology (mHealth app) as an educational, communication, audit, and feedback tool to promote patient-initiated clinical trial discussions among Black people with pancreatic cancer and their cancer care team.

There will be 2 groups: 20 subjects with pancreas carcinoma for phone interviews and 6 for user testing the first version of the application..

Promoting CT Engagement for Pancreatic Cancer With App

PROmoting CLinicAl TrIal EngageMent for Pancreatic Cancer App Study (PROCLAIM Study

The clinical trial education and communication needs of Black people with pancreatic cancer will be determined with feedback and qualitative analysis of findings from semi-structured interviews to develop an mHealth application.

Lustgarten Foundation

UNC Lineberger Comprehensive Cancer Center

Carcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Physicians and clinic staff provide and patients recieve CRC screening usual care throughout the trial.

Physicians and clinic staff receive ongoing training, education, and feedback on CRC screening, and utilize point-of-care clinical decision support tool throughout the trial. Patients receive CRC screening recommendations from provider, a FIT kit with culturally tailored instructions, consultation with clinic staff, and text message reminders throughout the trial.

Best Practice

Consultation

Recieve education and training on CRC screening

Educational Intervention

Electronic Health Record Review

Recieve FIT kit with culturally tailored instructions

Fecal Immunochemical Test

Health Education

Support Education Activity

Text Message-Based Navigation Intervention

Roshan Bastani

This clinical trial implements research strategies to increase colorectal cancer (CRC) screening rates among low income and ethnic minority groups. CRC is the second most common cause of cancer mortality in the United States and disproportionately burdens low income and ethnic minority groups. Fecal immunochemical testing (FIT) is a test to check for blood in the stool. A brush is used to collect water drops from around the surface of a stool while it is still in the toilet bowl. The samples are then sent to a laboratory, where they are checked for a human blood protein. Blood in the stool may be a sign of colorectal cancer. Despite its potential for reducing CRC incidence and mortality, screening remains woefully underutilized. There is an unmet need for practical and effective programs to improve CRC screening rates. By implementing a culturally-tailored screening CRC program that supports providers and clinic staff to encourage eligible patients to complete FIT, researchers hope to reduce cancer disparities among low-income and ethnic groups and increase the CRC screening rate, which will help providers find CRC sooner, when it may be easier to treat.

PRIMARY OBJECTIVE:

I. To increase CRC screening rates within Northeast Valley Health Corporation (NEVHC).

OUTLINE: Clinic sites are randomized to 1 of 2 groups.

GROUP I CLINICS: Physicians and clinic staff receive ongoing training, education, and feedback on CRC screening, and utilize point-of-care clinical decision support tool throughout the trial. Patients receive CRC screening recommendations from provider, a FIT kit with culturally tailored instructions, consultation with clinic staff, and text message reminders throughout the trial.

GROUP II CLINICS: Physicians and clinic staff provide and patients recieve CRC screening usual care throughout the trial.

Implementation Research to Increase Colorectal Cancer Screening Rates Among Low Income and Ethnic Minority Groups

Implementation Research to Reduce Colorectal Cancer Disparities

Patient-level study data on the primary outcome of CRC screening receipt will be assessed through electronic health record data systems. Fecal immunochemical test (FIT) is the screening method most commonly utilized in NEVHC. Patients who have completed a FIT within the past 12 months will be considered screened. Consistent with current CRC screening guidelines, patients screened via a flexible sigmoidoscopy in the past five years (very rare) or colonoscopy (very small numbers) in the past ten years will also be considered screened. The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients.

Missed opportunity rates will be calculated at baseline, end of study, and intermediate time points by determining the number of eligible patients who made a clinic visit but did not receive a FIT kit. The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients.

The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients.

Tobacco Related Disease Research Program

Jonsson Comprehensive Cancer Center

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Lymphosarcoma

Participants in the intervention arm will receive a Fitbit upon admission and will receive feedback from the activity tracker and the in-room TV screen as demonstrated by the Study Navigator. Study participants in this arm will be engaging with their physicians around achievement of daily step goals by viewing the in-room TV display of their daily step counts on rounds.

Subjects in the control arm will receive a Fitbit upon admission for their transplant but neither the physician, nurse, nor patient will receive any feedback from the device. They will be blinded to any data capture by their activity monitor. Nurses and doctors will not monitor ambulation with the activity monitor, they will use standard methods to encourage ambulation.

The system uses Sonifi health (TV content and visualizations) and Fitabase (3rd party server to process Fitbit data and export to Sonifi). The system utilizes the patient's TVs to engage the patient and multidisciplinary team in monitoring ambulation status.

Ron Paquette, MD

The purpose the research is to obtain preliminary data about the change in fitness from admission to discharge in patients undergoing an Autologous Stem Cell Transplant (ASCT) , assessed by the 6 minute walk test as the primary objective and the SF-36 as the secondary objective. All subjects will wear a Fitbit monitor while admitted for the ASCT to record their daily activity.

This study will enroll 20 subjects with a diagnosis of multiple myeloma or lymphoma (10 with each diagnosis) scheduled to undergo ASCT at Cedars-Sinai Medical Center.

After signing the informed consent form, intake data will be collected on all subjects will include age, diagnosis, Karnofsky performance status, and comorbidity index. Subjects will complete an SF-36 questionnaire that assesses their functional and emotional status. Each subject will undergo a 6-minute walk test (6MWT) while wearing a Fitbit monitor to record the number of steps taken. After admission, subjects will be randomly assigned to either the control or intervention group. Subjects in the control arm will receive an activity monitor but the physician, nurse, and patient will not receive any feedback from the device. Patients will be blinded to any data capture from their activity monitor. Participants in the intervention arm will receive an activity monitor and they will receive feedback from the activity tracker and the in-room TV screen. Study participants in this arm will engage with their physicians and nurses around achievement of daily step goals by viewing the in-room TV display of daily step counts on rounds. After discharge, all subjects will again complete the SF-36 questionnaire and perform a 6MWT at a routine clinic visit, within 30 days of the transplant procedure. Descriptive statistics in the form of mean and standard deviation will be used to summarize patient physical activity as measured by 6MWT.

Subjects who are randomized to not get feedback about their activity will not be aware that there is another group that is receiving feedback

Stepping Up: A Trial of Activity Monitoring Devices in Patients Undergoing Autologous Stem Cell Transplant

Standard 6 minute walk test will be performed

Standard SF-36 questionnaire will be completed

Cedars-Sinai Medical Center

Medical Director, Blood and Marrow Transplant Program

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

20 men with newly diagnosed clinically localized prostate cancers and utilize NLP to extract key content using the top five sentences by NLP probability for key content areas will be generated and will be provided to patients and providers within 2 weeks after each case.

Audio recordings will be made using either digital recorders or telehealth platform-generated transcripts. Patient reports will include only the extracted sentences related to content areas. Physician reports will note the extracted statements across each content area, the quality scores for individual statements based on the pre-specified hierarchy, the statements that achieved the highest score across each content area, and feedback on what could be improved. For patients, decisional conflict and risk perception will be assessed before and after receiving the NLP-based feedback. For physicians, the investigators will assess baseline quality of risk communication by pre-specified hierarchy, any changes in individual physician communication over time, and accuracy of risk estimates for key content areas.

NLP-based Feedback

Timothy Daskivich, MD

Antwon Chaplin

Timothy Daskivich

In this pilot study, the investigators will show feasibility of the NLP-based feedback system in 20 consultations of men with newly diagnosed prostate cancer. The investigators will recruit from the practices of up to 10 physicians who typically see these patients. The investigators will report the top five sentences from each consultation across key content areas (cancer prognosis, life expectancy, erectile dysfunction, urinary incontinence, and irritative urinary symptoms) to both patients and physicians within 2 weeks of the consultation.

The primary research procedures are:

1. Audio recording and transcribing treatment counseling discussions for 20 men with newly diagnosed clinically localized prostate cancers and utilize NLP to extract key content using the system described above.
2. Reports including the top five sentences by NLP probability for key content areas will be generated and will be provided to patients and providers within 2 weeks after each case.
3. For patients, decisional conflict and risk perception will be assessed before and after receiving the NLP-based feedback.
4. For physicians, the investigators will assess baseline quality of risk communication, any changes in individual physician communication over time, and accuracy of risk estimates for key content areas.
5. Within 2 weeks of receiving the NLP-based feedback, the investigators will conduct a 30-minute semi-structured interview with patients to obtain their opinions on the utility and ideal implementation strategy for the NLP-based feedback.
6. At the conclusion of the pilot trial, the investigators will conduct 30-minute semi-structured interview with counseling physicians to obtain their opinions on the utility and ideal implementation strategy for the NLP-based feedback.

NLP-Based Feedback to Improve Risk Comms and Informed Shared Decision Making

Natural Language Processing-Based Feedback to Improve Physician Risk Communication and Informed Shared Decision Making in Men With Clinically Localized Prostate Cancer

The investigators will employ the validated Decisional Conflict Scale (DCS), to estimate uncertainty associated with treatment choice. Effect sizes of 0.3 to 0.4 are considered meaningful. Variability (standard deviation) in DCS scores before and after receiving NLP-based feedback will be assessed and used in planning a larger trial.

The investigators will evaluate concordance of cancer risk perception with actual cancer risk at the patient level before and after the intervention. Cancer risk perception will be assessed by multiple-choice questions. Concordance of patient answers with actual cancer risk as estimated by outcomes of the SPCG-4 randomized trial comparing surgery versus watchful waiting at the patient's PCCI-predicted life expectancy will be assessed as a binary outcome. Risk perception will be assessed before and after their consultation. Variability (standard deviation) in risk perception scores before and after receiving NLP-based feedback will be assessed and used in planning a larger trial.

30-minute semi-structured interviews with counseling physicians will be conducted within 2 weeks of the intervention to obtain their opinions on the utility and ideal implementation strategy for the NLP-based feedback.

The difference in reported risk estimates given by physicians during the consultation as compared with the gold standards for these risks (i.e. for side effects, estimates from the CAESAR study; for cancer risk with and without treatment, risks of cancer mortality in the WW group of SPCG-4 trial at the patient's life expectancy as determined by the prostate cancer comorbidity index). Variability (standard deviation) in accuracy of estimates will be assessed and used in planning a larger trial. Accuracy of estimates for the interventional period will be compared with physician-specific historical references from a previously conducted trial using the standard of care (i.e. no NLP-based intervention).

Quality of risk communication scores will be calculated by qualitatively analyzing treatment consultation transcripts to assess the highest quality of communication used to transmit information regarding all key tradeoffs (cancer prognosis, life expectancy, erectile dysfunction, urinary incontinence, and irritative urinary symptoms). The quality of risk communication scale ranges from 0 to 5 for each outcome, with 0 representing the lowest score and 5 representing the highest score (Daskivich et al, J Urol 2022; Naser-Tavakolian et al, J Urol 2022). Scores for all key tradeoffs will be averaged to yield a composite quality of risk communication score. Variability (standard deviation) in quality scores will be assessed and used in planning a larger trial.

30-minute semi-structured interviews with patients will be conducted at the conclusion of the study period to obtain their opinions on the utility and ideal implementation strategy for the NLP-based feedback

National Cancer Institute (NCI)

Assistant Professor, Department of Urology

Nervous System Diseases

Behaviors and Mental Disorders

Dementia

Heart Failure

Heart Diseases

Brain Diseases

Central Nervous System Diseases

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Feedback to provider regarding frequency and quality of communication

Providers will receive detailed feedback about the timing, quality, and frequency of their goals of care communication with patients

The goal-concordant care lab will develop and test strategies to optimize communication in advanced serious illness.

The goal-concordant care lab will develop and test strategies to optimize communication in advanced serious illness. The lab will test a variety of interventions, including triggered conversations and feedback to healthcare providers.

Several interventions will be tested, at the patient and provider levels

Goal Concordant Care Learning Laboratory

Palliative Care Learning Laboratory

Frequency of goals of care conversations in the last 6 months of life

Proximity of goals of care communication to death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Implementation of Optical Diagnosis for Diminutive Polyps Amongst Endoscopists: Training and Long-term Quality Assurance	NCT02407925	Colonoscopy Colonic Polyps	Feedback	55 Years - 75 Years	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Promoting CT Engagement for Pancreatic Cancer With App	NCT06252545	Pancreas Cancer	semistructured ... feedback	18 Years -	UNC Lineberger Comprehensive Cancer Center
Implementation Research to Increase Colorectal Cancer Screening Rates Among Low Income and Ethnic Minority Groups	NCT06090643	Colorectal Carc...	Best Practice Consultation Educational Int... Electronic Heal... Fecal Immunoche... Feedback Health Educatio... Support Educati... Text Message-Ba...	50 Years - 75 Years	Jonsson Comprehensive Cancer Center
Stepping Up: A Trial of Activity Monitoring Devices in Patients Undergoing Autologous Stem Cell Transplant	NCT04985409	Multiple Myelom... Lymphoma Transplant-Rela...	Feedback	18 Years - 80 Years	Cedars-Sinai Medical Center
NLP-Based Feedback to Improve Risk Comms and Informed Shared Decision Making	NCT05923684	Prostate Cancer	NLP-based Feedb...	18 Years -	Cedars-Sinai Medical Center
Implementation of Optical Diagnosis for Diminutive Polyps Amongst Endoscopists: Training and Long-term Quality Assurance	NCT02407925	Colonoscopy Colonic Polyps	Feedback	55 Years - 75 Years	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Implementation Research to Increase Colorectal Cancer Screening Rates Among Low Income and Ethnic Minority Groups	NCT06090643	Colorectal Carc...	Best Practice Consultation Educational Int... Electronic Heal... Fecal Immunoche... Feedback Health Educatio... Support Educati... Text Message-Ba...	50 Years - 75 Years	Jonsson Comprehensive Cancer Center
Goal Concordant Care Learning Laboratory	NCT05879211	Cancer Heart Failure Copd Dementia	Feedback	18 Years -	Duke University

Spots Global Cancer Trial Database for feedback

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

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