- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04234646
Patient Navigation 2.0
Patient Navigation 2.0: Addressing the Challenge of Scaling Navigation Through Checklist-based Implementation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cancer patient navigation (PN) is an effective strategy for resolving patient barriers to care and improving completion and consistency of cancer screening, follow-up of abnormal findings, and treatment initiation. However, as the current standard one-on-one PN model is challenging to scale across cancers and economically difficult to sustain, the investigators propose to convert one-on-one PN into a learning health system "PN 2.0 Checklist" that will help coordinate navigation workflow and integrate clinical team members with community/local resources. This pragmatic, randomized trial tests whether this checklist strategy is as effective as one-on-one PN in addressing patients' social determinants of health and recommended cancer-related screenings, behavioral counseling, and immunizations.
In this study, half of the participants will be navigated using the "PN 2.0 Checklist". The other half will be navigated using the "One-on-One PN". All participants enrolled in the study will be asked to report their utilization of health services and be asked to complete a patient survey at the beginning of the program and every 6 months.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Melissa Simon, MD
- Phone Number: (312) 503-8780
- Email: m-simon2@northwestern.edu
Study Contact Backup
- Name: Laura Tom, MS
- Phone Number: (312) 503-0808
- Email: laura.tom@northwestern.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern
-
Contact:
- Ivy Leung
- Phone Number: 872-216-1878
- Email: ivy.leung@northwestern.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 21 or older
- Reside in one of the eight Chicago zip codes corresponding to Chinatown's geographical boundaries: 60605, 60607, 60608, 60609, 60616, 60623, 60632, 60653
- Self-identify as Chinese
- Not cognitively impaired
- Have the ability to participate in verbal survey in Cantonese, English, Mandarin, or Toishanese
Exclusion Criteria:
- Cognitive impairment
- Incarceration
- Under 21 years of age
- Adult unable to consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1: One-on-One Patient Navigation
One-on-one Patient Navigation will be based on a Case Management Model where patients navigators perform appointment scheduling and reminders; facilitate communication between patients and care teams; and identify and reduce patient barriers through education, outreach, and referrals to community, local, and state resources.
|
The one-on-one Patient Navigation will be based on a Case Management Model where PNs perform appointment scheduling and reminders; facilitate communication between patients and care teams; and identify and reduce patient barriers through education, outreach, and referrals to community, local, and state resources
|
Experimental: Group 2: Patient Navigation 2.0 Checklist
The PN 2.0 Checklist intervention is centered on a learning health system checklist that enumerates a patient's Social Determinants of Health (SDoH) related barriers and tracks completion of services to address SDoH (at community oncology and community social service settings) as well as completion of USPSTF recommended cancer-related screenings, behavioral counseling, and immunizations.
|
The PN 2.0 Checklist intervention is centered on a learning health system checklist that enumerates a patient's Social Determinants of Health (SDoH) related barriers and tracks completion of services to address SDoH (at community oncology and community social service settings) as well as completion of USPSTF recommended cancer-related screenings, behavioral counseling, and immunizations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Receipt of Clinical Cancer Preventive Services and Resolution of Social Determinants of Health Barriers
Time Frame: through study completion, an average of 18 months
|
Patient Receipt of Clinical Cancer Preventive Services and Resolution of Social Determinants of Health (SDoH) Barriers is an adjusted, composite proportion of items completed/resolved in 2 domains: (1) USPSTF recommended cancer screenings, behavioral counseling, and immunizations; and (2) SDoH barriers resolved from those identified in the Accountable Health Communities Health-Related Social Needs (AHC HRSN) Screening Tool
|
through study completion, an average of 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timeliness of diagnostic resolution
Time Frame: through study completion, an average of 18 months
|
Time from an abnormal screening result to diagnostic resolution
|
through study completion, an average of 18 months
|
Timeliness of treatment initiation
Time Frame: through study completion, an average of 18 months
|
Time from diagnostic resolution to initiation of treatment
|
through study completion, an average of 18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Melissa Simon, MD, Northwestern University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STU00211685
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
Clinical Trials on One-on-one Patient Navigation (PN)
-
NYU Langone HealthCenters for Disease Control and PreventionRecruitingCancer ScreeningUnited States
-
Icahn School of Medicine at Mount SinaiCompleted
-
Icahn School of Medicine at Mount SinaiNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
University of UtahNational Institutes of Health (NIH); National Center for Advancing Translational... and other collaboratorsCompleted
-
Columbia UniversityNational Institute on Drug Abuse (NIDA)CompletedSexual Behavior | Substance AbuseUnited States
-
Nancy SchoenbergNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Case Comprehensive Cancer CenterNational Institute on Minority Health and Health Disparities (NIMHD)CompletedCancer Survivor | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
Centre de Recherche de l'Institut Universitaire...Active, not recruitingUrinary Incontinence | Urinary Stress IncontinenceCanada
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...CompletedOverweight and ObesityUnited States
-
Oregon Health and Science UniversityNational Cancer Institute (NCI); National Institute of Arthritis and Musculoskeletal...CompletedCardiovascular Diseases | Cancer | Physical Activity | NutritionUnited States