- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04763824
KanSurvive: Testing a Model for Improving Cancer Survivorship Care in Rural Practice (KANSURVIVE)
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 (Aim 2) and finally identify barriers and facilitators to implementation of KanSurvive-ECHO (Aim 3).
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kansas
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Westwood, Kansas, United States, 66206
- University of Kansas Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primary care practice (PCP) caring for rural cancer survivors
- Willing to participate in four ECHO sessions
- Capable and willing to complete pre- and post- data collection under a data use agreement
- 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 unwilling to engage in project activities
- PCPs with no rural-dwelling patients on their patient panel
- Cancer survivor data is ineligible for extraction if 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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: KanSurvive Telementoring with Practice Facilitation
This study does not involve a therapeutic intervention. The KanSurvive project includes Project ECHO telementoring and education with practice facilitation to improve the delivery of cancer survivorship care in primary care practice. |
Four, 1-hour, virtual, case-based education sessions covering the evidence-based practice guidelines for breast, colorectal, lung, and prostate cancer survivorship care.
Practice facilitation also provided to support participating primary care practices with quality improvement in the delivery of cancer survivorship care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tumor Surveillance Completion (Pre-Intervention)
Time Frame: Baseline (Pre-Intervention) Chart Audit
|
This outcome reflects whether recommended tumor surveillance was completed and documented in the EHR.
Tumor surveillance includes cancer-specific follow-up imaging consistent with evidence-based survivorship guidelines (e.g., NCCN, ASCO).
Charts were coded as "Completed" if the recommended surveillance test was documented within the appropriate interval and "Not Completed" if documentation was absent, outdated, or incomplete.
The outcome reports the proportion of EHR charts meeting tumor surveillance recommendations at baseline (pre-intervention) and again 24 months after the intervention.
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Baseline (Pre-Intervention) Chart Audit
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Tumor Surveillance Completion (Post-Intervention)
Time Frame: 24-Month Follow-Up (Post-Intervention) Chart Audit
|
This outcome reflects whether recommended tumor surveillance was completed and documented in the EHR.
Tumor surveillance includes cancer-specific follow-up imaging consistent with evidence-based survivorship guidelines (e.g., NCCN, ASCO).
Charts were coded as "Completed" if the recommended surveillance test was documented within the appropriate interval and "Not Completed" if documentation was absent, outdated, or incomplete.
The outcome reports the proportion of EHR charts meeting tumor surveillance recommendations at baseline (pre-intervention) and again 24 months after the intervention.
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24-Month Follow-Up (Post-Intervention) Chart Audit
|
|
Distress Screening Completion (Pre-Intervention)
Time Frame: Baseline (Pre-intervention) Chart Review
|
This outcome reflects whether recommended Distress Screening was completed and documented in the EHR.
Distress Screening was defined as documentation of using a standardized distress assessment tool consistent with survivorship best practices.
Charts were coded as "Completed" when a distress screening result was documented during the chart abstraction interval.
"Not Complete" indicated missing or incomplete documentation.
|
Baseline (Pre-intervention) Chart Review
|
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Distress Screening Completion (Post-Intervention)
Time Frame: 24-Month Follow-Up (Post-Intervention) Chart Audit
|
This outcome reflects whether recommended Distress Screening was completed and documented in the EHR.
Distress Screening was defined as documentation of using a standardized distress assessment tool consistent with survivorship best practices.
Charts were coded as "Completed" when a distress screening result was documented during the chart abstraction interval.
"Not Complete" indicated missing or incomplete documentation.
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24-Month Follow-Up (Post-Intervention) Chart Audit
|
|
Body Mass Index (BMI) Assessment Completion (Pre-Intervention)
Time Frame: Baseline (Pre-intervention) Chart Review
|
BMI assessment was defined as documentation of a height and weight measurement sufficient to calculate body mass index (BMI) in the electronic health record (EHR).
Charts were coded as "Completed" when BMI or its components were documented within the recommended timeframe.
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Baseline (Pre-intervention) Chart Review
|
|
Body Mass Index (BMI) Assessment Completion (Post-Intervention)
Time Frame: 24-Month Follow-Up (Post-Intervention) Chart Audit
|
BMI assessment was defined as documentation of a height and weight measurement sufficient to calculate body mass index (BMI) in the electronic health record (EHR).
Charts were coded as "Completed" when BMI or its components were documented within the recommended timeframe.
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24-Month Follow-Up (Post-Intervention) Chart Audit
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Tobacco Use Screening Completion (Pre-Intervention)
Time Frame: Baseline (Pre-Intervention) Chart Audit
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Tobacco use screening was defined as documentation of current tobacco use status in the electronic health record (EHR).
Charts were coded as "Completed" when a screening result was documented within the recommended timeframe.
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Baseline (Pre-Intervention) Chart Audit
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Tobacco Use Screening Completion (Post-Intervention)
Time Frame: 24-Month Follow-Up (Post-Intervention) Chart Audit
|
Tobacco use screening was defined as documentation of current tobacco use status in the electronic health record (EHR).
Charts were coded as "Completed" when a screening result was documented within the recommended timeframe.
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24-Month Follow-Up (Post-Intervention) Chart Audit
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Cancer Diagnosis on Problem List (Pre-Intervention)
Time Frame: Baseline (Pre-Intervention) Chart Audit
|
This outcome reflects whether a cancer diagnosis was documented on the patient's EHR problem list, consistent with survivorship care documentation standards.
Charts were coded as "Completed" when the cancer diagnosis appeared in the structured problem list.
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Baseline (Pre-Intervention) Chart Audit
|
|
Cancer Diagnosis on Problem List (Post-Intervention)
Time Frame: 24-Month Follow-Up (Post-Intervention) Chart Audit
|
This outcome reflects whether a cancer diagnosis was documented on the patient's EHR problem list, consistent with survivorship care documentation standards.
Charts were coded as "Completed" when the cancer diagnosis appeared in the structured problem list.
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24-Month Follow-Up (Post-Intervention) Chart Audit
|
|
Family History of Cancer Documentation (Pre-Intervention)
Time Frame: Baseline (Pre-intervention) Chart Audit
|
Family history of cancer documentation was defined as the presence of cancer-related family history information in the EHR.
Charts were coded as "Completed" when documentation included a family history of cancer assessment entry.
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Baseline (Pre-intervention) Chart Audit
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Family History of Cancer Documentation (Post-Intervention)
Time Frame: 24-Month Follow-Up (Post-Intervention) Chart Audit
|
Family history of cancer documentation was defined as the presence of cancer-related family history information in the EHR.
Charts were coded as "Completed" when documentation included a family history of cancer assessment entry.
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24-Month Follow-Up (Post-Intervention) Chart Audit
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
60 month
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Intestinal Diseases
- Respiratory Tract Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Colonic Diseases
- Skin Diseases
- Breast Diseases
- Skin and Connective Tissue Diseases
- Prostatic Neoplasms
- Lung Neoplasms
- Colorectal Neoplasms
- Breast Neoplasms
Other Study ID Numbers
- STUDY00144314
- 5R01CA240103-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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