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

Primary Purpose

Breast Cancer, Colorectal Cancer, Lung Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telementoring with Practice Facilitation
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring Cancer Survivorship, Rural Primary Care Practices

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kansas Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

cluster-randomized controlled trial, with delayed start control arm

cluster-randomized controlled trial, intervention

Arm Description

Control arm/Delayed Onset

Intervention arm

Outcomes

Primary Outcome Measures

Percent change in evidence based cancer screening
Percent change in evidence-based cancer screening practices as documented in the electronic health record from pre- to 15-months post intervention.

Secondary Outcome Measures

Full Information

First Posted
November 25, 2020
Last Updated
May 11, 2023
Sponsor
University of Kansas Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04763824
Brief Title
KanSurvive: Testing a Model for Improving Cancer Survivorship Care in Rural Practice
Acronym
KANSURVIVE
Official Title
KanSurvive: Testing a Model for Improving Cancer Survivorship Care in Rural Practice
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer
Keywords
Cancer Survivorship, Rural Primary Care Practices

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cluster-randomized trial with delayed-start control arm
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cluster-randomized controlled trial, with delayed start control arm
Arm Type
Active Comparator
Arm Description
Control arm/Delayed Onset
Arm Title
cluster-randomized controlled trial, intervention
Arm Type
Experimental
Arm Description
Intervention arm
Intervention Type
Behavioral
Intervention Name(s)
Telementoring with Practice Facilitation
Other Intervention Name(s)
Project ECHO
Intervention Description
We are attempting to provide education and encourage practice change
Primary Outcome Measure Information:
Title
Percent change in evidence based cancer screening
Description
Percent change in evidence-based cancer screening practices as documented in the electronic health record from pre- to 15-months post intervention.
Time Frame
60 months
Other Pre-specified Outcome Measures:
Title
Participation rates in the Telementoring and Practice Facilitation Sessions
Description
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.
Time Frame
60 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Must be a primary care practice caring for rural cancer survivors Must be willing to participate in four ECHO sessions Must be capable and willing to complete pre- and post- data collection
Facility Information:
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.

Learn more about this trial

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

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