- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07528963
KanSurvive 2.0: Testing Enhanced Models of Cancer Survivorship Care for Rural Cancer Survivors in Primary Care Practice
April 7, 2026 updated by: University of Kansas Medical Center
Rural cancer survivors experience a higher risk of negative health outcomes and require coordinated care to address the many effects of cancer and its treatment.
Primary care providers recognize the importance of providing high-quality, evidence-based survivorship care and are well-positioned to meet survivor needs, however, these needs are often unmet due to limitations in knowledge, lack of resources, and administrative demands.
Practical strategies are needed to help PCPs improve cancer survivorship care, and this proposal will test implementation strategies to optimize the adoption of evidence-based practices for cancer survivorship care in rural primary care settings.
Study Overview
Status
Enrolling by invitation
Conditions
Detailed Description
Cancer survivors require long-term and coordinated care to address the physical, emotional, and psychosocial effects of cancer and its treatment.
Rural cancer survivors are disproportionately affected by chronic illness and face a higher risk of negative health outcomes.
Primary care providers (PCPs) recognize the importance of delivering evidence-based practice (EBP) cancer survivorship care and are well-positioned to provide comprehensive and coordinated care, however, the needs of cancer survivors are frequently unmet, and providers describe limitations in knowledge of risk-based surveillance, long-term effects of cancer treatment and their management, inadequate resources, and growing administrative demands as barriers to improving survivorship care.
The overall goal of this project is to test the effectiveness of pragmatic strategies to promote high quality, evidence-based guideline concordant care for rural adult cancer survivors in primary care practice and utilizing tools from implementation science to gain a better understanding of the decision making and actions taken that facilitate or hinder implementation across multiple healthcare systems.
To achieve this objective, we propose a three-arm cluster-randomized, multi-level intervention to provide education, tele-mentoring, and whether 1) virtual scribes filling the role as trained medical assistants, 2) a team-based approach, 3) or usual care produces more guideline concordant cancer survivorship care.
The primary outcome is provider adherence to EBP cancer survivorship guidelines as measured using a previously developed composite scoring system that compares electronic health record (EHR) documented activity to National Comprehensive Cancer Network guidelines.
The secondary outcome is to assess intervention sustainability of arm 1 and 2 activities at 12 and 24-months post implementation; measured as a function of virtual scribe or team-based actions to promote prior cancer diagnoses coding (ICD-10), use of EHR tools and health maintenance order sets and annual ordering of appropriate screenings for cancer survivors.
Prior to implementation, formative evaluations will assess current systems of care and practice-level barriers and facilitators for the delivery of EBP cancer survivorship care and inform modifications to implementation strategies.
Guided by the Normalization Process Theory, we will examine agentic factors (e.g., actions taken/decisions made by the practice) to modify modes of care management and delivery.
The RE-AIM evaluation framework will be used to explore potential population-level impact and generalizability of the intervention in real-world clinical settings.
The study will be conducted in 16 rural primary care practices in Kansas and was intentionally designed to bring care delivery changes into resource-limited practices and health systems.
Results will add new evidence by informing pragmatic strategies to facilitate the adoption and delivery of EBP cancer survivorship in rural primary care.
Study Type
Interventional
Enrollment (Estimated)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / 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
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
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Allen K Greiner, MD, MPH, University of Kansas Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
June 30, 2029
Study Registration Dates
First Submitted
April 15, 2025
First Submitted That Met QC Criteria
April 7, 2026
First Posted (Actual)
April 14, 2026
Study Record Updates
Last Update Posted (Actual)
April 14, 2026
Last Update Submitted That Met QC Criteria
April 7, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00160108
- U01CA290664 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Research resources generated within this project will be explicitly developed in an effort to improve cancer survivorship outcomes in rural primary care practice.
We will develop a strategic plan with the KU Cancer Center and NCI to widely disseminate any product, intellectual property, or data to promote scientific activity and health promotion work that will be of assistance to similar patient populations.
As such, we will work to fully share these materials and items with qualified individuals across the greater scientific community and with rural practices, providers and community members.
All program materials and data generated within the overall study will be shared to the fullest extent possible.
De-identified data from this project will be preserved and shared in a public repository to validate and replicate research findings described in the Aims.
IPD Sharing Time Frame
Start date: June 2026 End date: June 2029
IPD Sharing Access Criteria
De-identified study data will be made available as public use data to the research community via Open Science Framework.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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