KanSurvive 2.0: Testing Enhanced Models of Cancer Survivorship Care for Rural Cancer Survivors in Primary Care Practice
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Rural primary care practice (PCP) located within rural urban continuum codes (RUCC) 4-9 in Kansas
- PCPs must have multiple providers
- PCPs must have at least on medical assistant
- PCPs must have an employed medical scribe or be willing to consider employing a medical scribe using study compensation and practice revenue
- Cancer survivor data is eligible for extraction if the patient is a breast, prostate, lung, and/or colorectal cancer survivor and considered to have a "reasonable likelihood" of 24-month survival by a practice provider.
Exclusion criteria:
- PCPs not located within RUCC 4-9 in Kansas
- PCPs without multiple providers
- PCPs without a medical assistant
- PCPs without a medical scribe or unwilling to consider employing one
- Cancer survivorship data is ineligible for extraction is the patient is <18 years of age or >75 years of age, is currently receiving hospice services, or has a history of cancer other than breast, prostate, lung, or colorectal.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Virtual Scribe Medical Assistant
Virtual scribe medical assistants will engage in KanSurvive 2.0 Project ECHO education assist with clinical documentation, identifying cancer survivors, and scrubbing electronic health records to identify care gaps and opportunities for quality improvement with practice facilitation.
|
Telementoring, education, and case-based learning covering evidence-based practice guidelines for breast, colorectal, lung, and prostate cancer survivorship.
Practice facilitation will be delivered to assist with quality improvement efforts using monthly Plan Do Study Act (PDSA) cycles.
Printed and digital manuals will be distributed to each participating primary care practice to share with the cancer survivors they see in their clinic.
The manual guides patients on how to engage more effectively with their PCP and oncology care team and reviews recommended follow-up, within a format of a "service manual" and written in lay language.
Participating practices who opt-in to receive virtual scribe services.
|
|
Active Comparator: Team Based Care
Rural primary care practice teams will assist with clinical documentation, identifying cancer survivors, and reviewing electronic health records to identify care gaps and opportunities for quality improvement with practice facilitation.
|
Telementoring, education, and case-based learning covering evidence-based practice guidelines for breast, colorectal, lung, and prostate cancer survivorship.
Practice facilitation will be delivered to assist with quality improvement efforts using monthly Plan Do Study Act (PDSA) cycles.
Printed and digital manuals will be distributed to each participating primary care practice to share with the cancer survivors they see in their clinic.
The manual guides patients on how to engage more effectively with their PCP and oncology care team and reviews recommended follow-up, within a format of a "service manual" and written in lay language.
|
|
Placebo Comparator: Enhanced Usual Care
This attention control arm will engage in KanSurvive 2.0 Project ECHO education and receive an obesity management toolkit.
|
Telementoring, education, and case-based learning covering evidence-based practice guidelines for breast, colorectal, lung, and prostate cancer survivorship.
Printed and digital manuals will be distributed to each participating primary care practice to share with the cancer survivors they see in their clinic.
The manual guides patients on how to engage more effectively with their PCP and oncology care team and reviews recommended follow-up, within a format of a "service manual" and written in lay language.
The Enhanced Usual Care arm will receive a short, virtual training and toolkit on the management of obesity in primary care practice and how it relates to cancer survivorship.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Provider Adherence to Cancer Survivorship Guidelines Measured by EHR-Based Composite Adherence Score
Time Frame: Assessed at baseline, 6, 12, and 24 months
|
The primary outcome is provider adherence to evidence-based cancer survivorship guidelines, measured using a composite score derived from electronic health record (EHR) data abstraction.
The composite score assesses concordance between documented care and National Comprehensive Cancer Network (NCCN) survivorship guidelines across multiple domains (e.g., tumor surveillance, distress screening, BMI assessment, tobacco use screening, family history of cancer documentation, osteoporosis screening, and hereditary cancer risk assessment).
Scores are calculated based on the proportion of eligible guideline-concordant care processes completed for each patient and aggregated at the clinic level.
|
Assessed at baseline, 6, 12, and 24 months
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Allen K Greiner, MD, MPH, University of Kansas Medical Center
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- STUDY00160108
- U01CA290664 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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.
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