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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

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).


Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Lung Cancer Prostate Cancer Behavioral: Telementoring with Practice Facilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: KanSurvive: Testing a Model for Improving Cancer Survivorship Care in Rural Practice
Actual Study Start Date : November 18, 2020
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: cluster-randomized controlled trial, with delayed start control arm
Control arm/Delayed Onset
Behavioral: Telementoring with Practice Facilitation
We are attempting to provide education and encourage practice change
Other Name: Project ECHO

Experimental: cluster-randomized controlled trial, intervention
Intervention arm
Behavioral: Telementoring with Practice Facilitation
We are attempting to provide education and encourage practice change
Other Name: Project ECHO




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04763824


Contacts
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Contact: Catie Knight, MPH 913-588-3666 cknight2@kumc.edu
Contact: Ellie Brent, MPH 913-945-7533 ebrent@kumc.edu

Locations
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United States, Kansas
University of Kansas Cancer Center Recruiting
Westwood, Kansas, United States, 66206
Contact: Catie Knight, MPH    913-588-3666    cknight2@kumc.edu   
Contact: Ellie Brent, MPH    913-945-7533    ebrent@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center
National Cancer Institute (NCI)
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Responsible Party: Jennifer Klemp, PhD, MA, MPH, Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT04763824    
Other Study ID Numbers: STUDY00144314
5R01CA240103-02 ( U.S. NIH Grant/Contract )
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Klemp, PhD, MA, MPH, University of Kansas Medical Center:
Cancer Survivorship
Rural Primary Care Practices
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases