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KanSurvive: Testing a Model for Improving Cancer Survivorship Care in Rural Practice (KANSURVIVE)

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ClinicalTrials.gov Identifier: NCT04763824
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jennifer Klemp, PhD, MA, MPH, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE November 25, 2020
First Posted Date  ICMJE February 21, 2021
Last Update Posted Date February 21, 2021
Actual Study Start Date  ICMJE November 18, 2020
Estimated Primary Completion Date July 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2021)
Percent change in evidence based cancer screening [ Time Frame: 60 months ]
Percent change in evidence-based cancer screening practices as documented in the electronic health record from pre- to 15-months post intervention.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: February 18, 2021)
Participation rates in the Telementoring and Practice Facilitation Sessions [ Time Frame: 60 month ]
Participation rates will calculated as the total number of rural primary care practices who express interest in the program divided by the total number of eligible rural primary care sites.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE KanSurvive: Testing a Model for Improving Cancer Survivorship Care in Rural Practice
Official Title  ICMJE KanSurvive: Testing a Model for Improving Cancer Survivorship Care in Rural Practice
Brief Summary

Approximately, 20 rural primary care practices to participate in a delayed intervention-controlled trial.

Phase I: Formal and structured work flow evaluations to better identify specific gaps in processes of care while assessing what on-going training is needed for adoption of high-quality cancer survivorship care in rural practice. These will be incorporated into the ECHO sessions (Aim 1).

Phase II: Conduct and test the effectiveness of the novel KanSurvive-ECHO intervention (Aim2) and finally identify barriers and facilitators to implementation of KanSurvive-ECHO (Aim 3).

Detailed Description

While evidence-based practice (EBP) guidelines exist for cancer survivorship care, implementation in rural practices has fallen short. Approximately 72.5% of Kansas cancer survivors who have completed their cancer treatment receive a majority of their health care from Primary Care Providers, yet these providers describe a lack of basic awareness of risk-based surveillance, effects of cancer treatment and their management, as well as inadequate resources, and growing administrative demands as reasons for not working to improve survivorship care. These factors may also prevent shared care management of cancer survivors between primary care and rural oncology care providers. There is a pressing need to understand primary care practice capacity to implement guideline informed management and follow-up for cancer survivors in the acute and extended phases of care.

Specific Aim 1. Formally assess gaps in processes of care and additional training needed to result in actual adoption of high-quality care for acute and chronic survivors of breast, colorectal, lung, and prostate cancer in 20 rural primary care practices. Utilize this formative information to further refine the KanSurvive-ECHO.

Specific Aim 2. Evaluate the effectiveness of KanSurvive-ECHO for enhancing evidence-based survivorship care for rural breast, colorectal, lung, and prostate cancer survivors.

Hypothesis: Compared to delayed intervention control, rural primary care practices randomized to KanSurvive-ECHO will demonstrate greater concordance with evidence-based survivorship care guidelines as measured by a composition score determined by change in EHR documentation consistent with guideline concordant care.

Specific Aim 3: Utilizing the Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework describe key facilitators and barriers to implementation of KanSurvive-ECHO including innovation, recipients, context, and facilitation.

This novel project will provide a model for development of a community of practice using practice facilitation and Project ECHO to improve the management and follow-up of cancer survivors in the acute and extended phases of cancer survivorship.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Breast Cancer
  • Colorectal Cancer
  • Lung Cancer
  • Prostate Cancer
Intervention  ICMJE Behavioral: Telementoring with Practice Facilitation
We are attempting to provide education and encourage practice change
Other Name: Project ECHO
Study Arms  ICMJE
  • Active Comparator: cluster-randomized controlled trial, with delayed start control arm
    Control arm/Delayed Onset
    Intervention: Behavioral: Telementoring with Practice Facilitation
  • Experimental: cluster-randomized controlled trial, intervention
    Intervention arm
    Intervention: Behavioral: Telementoring with Practice Facilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 18, 2021)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2024
Estimated Primary Completion Date July 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must be a rural primary care practice in Kansas
  • Must be willing to participate in four ECHO sessions
  • Must be capable and willing to complete pre- and post- data collection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Catie Knight, MPH 913-588-3666 cknight2@kumc.edu
Contact: Ellie Brent, MPH 913-945-7533 ebrent@kumc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04763824
Other Study ID Numbers  ICMJE STUDY00144314
5R01CA240103-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.
Responsible Party Jennifer Klemp, PhD, MA, MPH, University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE Not Provided
PRS Account University of Kansas Medical Center
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP