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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA240103-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KanSurvive Telementoring with Practice Facilitation | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KanSurvive ECHO and Practice Facilitation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Surveillance Completion (Pre-Intervention) | 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. | Baseline (Pre-Intervention) Chart Audit |
| Tumor Surveillance Completion (Post-Intervention) | 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. | 24-Month Follow-Up (Post-Intervention) Chart Audit |
| Distress Screening Completion (Pre-Intervention) | 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 |
| Distress Screening Completion (Post-Intervention) | 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Cancer Center | Westwood | Kansas | 66206 | United States |
There is not a plan to make IPD available.
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Clinics were the unit of assignment. The intervention was delivered at the clinic level. Outcome data were collected through retrospective, de-identified EHR chart reviews. Participants represent chart abstractions for cancer survivors seen during two independent audit periods: a baseline (pre-intervention) chart audit and a 24-month post-intervention chart audit. These audit samples were drawn from the same participating clinics but do not represent the same individual cancer survivors.
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| ID | Title | Description |
|---|---|---|
| FG000 | Baseline (Pre-Intervention) Chart Audit | This arm represents the baseline, pre-intervention chart audit sample drawn from participating primary care clinics. Charts included in this audit reflect an independent analytic sample of cancer survivors being seen in the practice. Demographic characteristics were abstracted at this time point to describe the baseline sample. Analyses are descriptive and no inferential comparisons were conducted between baseline and post-intervention samples. |
| FG001 | 24-Month (Post-Intervention) Follow-Up Chart Audit | This arm represents the analytic sample of EHR charts reviewed at the 24-month post-intervention time point. Charts reflect an independent sample drawn from the same participating clinics and do not necessarily represent the same cancer survivors included in the baseline chart audit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Arm |
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| Post-Intervention Arm |
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"Participants" represent EHR charts selected for analysis from participating primary care clinics. Charts were abstracted during two independent audit periods-baseline (pre-intervention) and 24-month post-intervention-and do not represent the same individual cancer survivors followed longitudinally. No human participants were prospectively enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline (Pre-Intervention) Chart Audit | This arm represents the baseline, pre-intervention chart audit sample drawn from participating primary care clinics prior to implementation of the KanSurvive ECHO + Practice Facilitation intervention. Charts included in this audit reflect an independent analytic sample of cancer survivors and do not necessarily represent the same individuals included in the baseline chart audit. Demographic characteristics were abstracted at this time point (Baseline) to describe the post-intervention sample. Analyses are descriptive and no inferential comparisons were conducted between baseline and post-intervention samples. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age (mean and standard deviation) was abstracted from EHR charts included in the baseline sample (n=138). Values reflect age at the baseline pre-intervention period. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tumor Surveillance Completion (Pre-Intervention) | 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. | Analysis population includes all EHR charts meeting inclusion criteria with complete documentation for the specified time point. Differences in sample size between baseline and post-intervention reflect routine variation in chart availability and completeness across clinics | Posted | Count of Participants | Participants | Baseline (Pre-Intervention) Chart Audit |
|
No adverse event monitoring was conducted because this was a retrospective EHR chart-review study with no enrolled patient participants.
Because this study consisted solely of retrospective abstraction of electronic health record (EHR) data and did not involve prospective enrollment or exposure to an intervention, no adverse event assessments were performed. Adverse events were therefore not monitored or reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baseline (Pre-Intervention) Chart Audit | Participants in this group represent independent EHR chart audit samples drawn from participating clinics. |
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This study relied on retrospective EHR abstraction in rural primary care practices, and documentation variability may not fully reflect all care delivered. Differences in baseline and post-intervention sample sizes reflect routine variation in chart availability and completeness. Data collection occurred during and following the COVID-19 pandemic, which affected project implementation, staffing and workflows.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Klemp, PhD, Principal Investigator | The University of Kansas Medical Center | 9135887750 | 3662 | jklemp@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 9, 2020 | Apr 25, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D008175 | Lung Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Single-arm feasibility study aimed at evaluating the effectiveness of the KanSurvive ECHO intervention combined with practice facilitation to promote the adoption of evidence-based practice survivorship care guidelines.
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| 24-Month Follow-Up (Post-Intervention) Chart Audit |
| Body Mass Index (BMI) Assessment Completion (Pre-Intervention) | 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. | Baseline (Pre-intervention) Chart Review |
| Body Mass Index (BMI) Assessment Completion (Post-Intervention) | 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. | 24-Month Follow-Up (Post-Intervention) Chart Audit |
| Tobacco Use Screening Completion (Pre-Intervention) | 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. | Baseline (Pre-Intervention) Chart Audit |
| Tobacco Use Screening Completion (Post-Intervention) | 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. | 24-Month Follow-Up (Post-Intervention) Chart Audit |
| Cancer Diagnosis on Problem List (Pre-Intervention) | 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. | Baseline (Pre-Intervention) Chart Audit |
| Cancer Diagnosis on Problem List (Post-Intervention) | 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. | 24-Month Follow-Up (Post-Intervention) Chart Audit |
| Family History of Cancer Documentation (Pre-Intervention) | 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. | Baseline (Pre-intervention) Chart Audit |
| Family History of Cancer Documentation (Post-Intervention) | 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. | 24-Month Follow-Up (Post-Intervention) Chart Audit |
| NOT COMPLETED |
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| BG001 | 24-Month Follow-Up (Post-Intervention) Chart Audit | This arm represents the 24-month post-intervention chart audit sample drawn from the same participating primary care clinics following implementation of the KanSurvive ECHO + Practice Facilitation intervention. Charts included in this audit reflect an independent analytic sample of cancer survivors and do not necessarily represent the same individuals included in the baseline chart audit. Demographic characteristics were abstracted at this time point (Post) to describe the post-intervention sample. Analyses are descriptive and no inferential comparisons were conducted between baseline and post-intervention samples. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex was abstracted from EHR charts included in the baseline sample (n=138). Counts reflect the baseline pre-intervention period. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity was abstracted from EHR charts included in the baseline sample (n=138) at the pre-intervention time point. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race was abstracted from EHR charts included in the baseline sample (n=138). Categories reflect OMB race classifications. | Count of Participants | Participants |
|
| Number of EHR charts analyzed at baseline | "Participants" represent EHR charts selected for baseline analysis in a rural primary care survivorship intervention. No human participants were enrolled. Baseline characteristics reflect chart-level variables collected at the pre-intervention time point. | Number | EHR charts |
|
| KanSurvive ECHO + Practice Facilitation |
This was a single-arm, delayed-start, clinic-level design. Primary care clinics were the unit of assignment and all clinics received the same KanSurvive ECHO + practice facilitation intervention. Pre- and post-intervention data represent chart abstractions, not longitudinal follow-up of the same individuals." |
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| Primary | Tumor Surveillance Completion (Post-Intervention) | 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. | Analysis population includes all EHR charts meeting inclusion criteria with complete documentation for the specified time point. Differences in sample size between baseline and post-intervention reflect routine variation in chart availability and completeness across clinics. | Posted | Count of Participants | Participants | 24-Month Follow-Up (Post-Intervention) Chart Audit |
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| Primary | Distress Screening Completion (Pre-Intervention) | 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. | Analysis population includes all EHR charts meeting inclusion criteria with complete documentation for the specified time point. Differences in sample size between baseline and post-intervention reflect routine variation in chart availability and completeness across clinics | Posted | Count of Participants | Participants | Baseline (Pre-intervention) Chart Review |
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| Primary | Distress Screening Completion (Post-Intervention) | 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. | Analysis population includes all EHR charts meeting inclusion criteria with complete documentation for the specified time point. Differences in sample size between baseline and post-intervention reflect routine variation in chart availability and completeness across clinics. | Posted | Count of Participants | Participants | 24-Month Follow-Up (Post-Intervention) Chart Audit |
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| Primary | Body Mass Index (BMI) Assessment Completion (Pre-Intervention) | 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. | Analysis population includes all EHR charts meeting inclusion criteria with complete documentation for the specified time point. Differences in sample size between baseline and post-intervention reflect routine variation in chart availability and completeness across clinics | Posted | Count of Participants | Participants | Baseline (Pre-intervention) Chart Review |
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| Primary | Body Mass Index (BMI) Assessment Completion (Post-Intervention) | 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. | Analysis population includes all EHR charts meeting inclusion criteria with complete documentation for the specified time point. Differences in sample size between baseline and post-intervention reflect routine variation in chart availability and completeness across clinics | Posted | Count of Participants | Participants | 24-Month Follow-Up (Post-Intervention) Chart Audit |
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| Primary | Tobacco Use Screening Completion (Pre-Intervention) | 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. | Analysis population includes all EHR charts meeting inclusion criteria with complete documentation for the specified time point. Differences in sample size between baseline and post-intervention reflect routine variation in chart availability and completeness across clinics | Posted | Count of Participants | Participants | Baseline (Pre-Intervention) Chart Audit |
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| Primary | Tobacco Use Screening Completion (Post-Intervention) | 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. | Analysis population includes all EHR charts meeting inclusion criteria with complete documentation for the specified time point. Differences in sample size between baseline and post-intervention reflect routine variation in chart availability and completeness across clinics | Posted | Count of Participants | Participants | 24-Month Follow-Up (Post-Intervention) Chart Audit |
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| Primary | Cancer Diagnosis on Problem List (Pre-Intervention) | 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. | Analysis population includes all EHR charts meeting inclusion criteria with complete documentation for the specified time point. Differences in sample size between baseline and post-intervention reflect routine variation in chart availability and completeness across clinics | Posted | Count of Participants | Participants | Baseline (Pre-Intervention) Chart Audit |
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| Primary | Cancer Diagnosis on Problem List (Post-Intervention) | 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. | Analysis population includes all EHR charts meeting inclusion criteria with complete documentation for the specified time point. Differences in sample size between baseline and post-intervention reflect routine variation in chart availability and completeness across clinics | Posted | Count of Participants | Participants | 24-Month Follow-Up (Post-Intervention) Chart Audit |
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| Primary | Family History of Cancer Documentation (Pre-Intervention) | 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. | Analysis population includes all EHR charts meeting inclusion criteria with complete documentation for the specified time point. Differences in sample size between baseline and post-intervention reflect routine variation in chart availability and completeness across clinics. | Posted | Count of Participants | Participants | Baseline (Pre-intervention) Chart Audit |
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| Primary | Family History of Cancer Documentation (Post-Intervention) | 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. | Analysis population includes all EHR charts meeting inclusion criteria with complete documentation for the specified time point. Differences in sample size between baseline and post-intervention reflect routine variation in chart availability and completeness across clinics. | Posted | Count of Participants | Participants | 24-Month Follow-Up (Post-Intervention) Chart Audit |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 24-Month Follow-Up (Post-Intervention) Chart Audit | Participants in this group represent independent EHR chart audit samples drawn from the same participating clinics. Cancer survivors charts included in the baseline (pre-intervention) chart audit are not necessarily the same cancer survivors included in the 24-month post-intervention chart audit. Therefore, the number of participants starting the post-intervention period is not expected to equal the number who completed the baseline period. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |