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Adherence to Survivorship Care Guidelines in Health Care Providers for Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care

Primary Purpose

Adenocarcinoma of the Lung, Mucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational intervention
medical chart review
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Adenocarcinoma of the Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HEALTH CARE PROVIDER INCLUSION CRITERIA:
  • Any health care provider (physician, advanced practice clinician) at a study site (Fox Chase Cancer Center [FCCC] and Fox Chase Cancer Center Partners [FCCCP]) who provides care for NSCLC and/or CRC survivors
  • CHART AUDIT INCLUSION CRITERIA (BASELINE):
  • Cancer Registry cases include stage I-III colon cancer (adenocarcinoma histology), stage I-III rectal cancer (adenocarcinoma histology), stage I-III non-small cell lung cancer (squamous or adenocarcinoma histology)
  • Patients must have completed all therapy for curative intent at least six months prior to chart audit
  • Undergoing routine oncology care and surveillance at the chosen site (defined as receiving follow-up care with FCCC or FCCCP site health care providers and have an active medical chart)
  • No evidence of metastatic disease
  • Patients must have been seen for a visit for cancer surveillance between 2009 and 2013
  • Health care providers at the participating site must be willing and able to participate in the educational initiative
  • CHART AUDIT INCLUSION CRITERIA (POST-INTERVENTION)
  • Charts eligible for audit after completion of the educational initiative will be for those CRC and NSCLC survivors presenting for follow-up after the initiative has been completed by site health care providers

Exclusion Criteria:

  • CHART AUDIT EXCLUSION CRITERIA:
  • Cancer Registry cases for diseases other than colon or rectal adenocarcinoma and non-small cell lung cancer (squamous or adenocarcinoma histology)
  • Patients currently receiving active therapy for any cancer, including CRC or NSCLC
  • Patients who do not undergo routine oncologic care at the chosen Partners site or Fox Chase Cancer Center
  • Stage IV cancer or evidence of metastatic disease at any time point
  • Patients who have not undergone a visit for cancer surveillance since 2009
  • Fox Chase Cancer Partners sites who do not agree to chart audit procedures or providers are unable or unwilling to participate in the educational initiative

Sites / Locations

  • Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Health services research (educational intervention)

Arm Description

Health care providers complete an educational intervention based on NCCN guidelines in CRC and NSCLC survivorship care comprising a power point presentation reviewing evidence and prompts for addressing survivorship care components; and an electronic paper copy sample survivorship care plan that can be adapted and distributed at each participating site.

Outcomes

Primary Outcome Measures

Percentage of eligible CRC and NSCLC survivors with medical record documentation of compliance with NCCN guidelines
A test of the binomial proportion will have 99% power with 1% type I error to make this distinction.

Secondary Outcome Measures

Change in percentage of eligible survivors with documentation of compliance with NCCN survivorship guidelines after conducting the targeted educational initiative at participating sites
This two-sample test of binomial proportions will have 99% power with 1% type I error.

Full Information

First Posted
November 9, 2012
Last Updated
April 5, 2017
Sponsor
Fox Chase Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01726296
Brief Title
Adherence to Survivorship Care Guidelines in Health Care Providers for Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care
Official Title
Adherence to NCCN Survivorship Care Guidelines in Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical trial studies adherence to survivorship care guidelines in health care providers for non-small cell lung cancer or colorectal cancer survivor care. The completion of an educational intervention by health care providers may increase compliance and adherence to National Comprehensive Cancer Network guidelines for survivorship care.
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate adherence of oncology health care providers to National Comprehensive Cancer Network (NCCN) guidelines for cancer survivorship care in colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) cancers. SECONDARY OBJECTIVES: I. To develop and assess a targeted educational initiative to improve compliance with NCCN CRC and NSCLC survivorship guidelines for oncology health care providers in academic and community practice. II. To evaluate the impact of this educational initiative on documented adherence and compliance with NCCN guidelines for NSCLC and CRC survivorship care by oncology health care providers. OUTLINE: Health care providers complete an educational intervention based on NCCN guidelines in CRC and NSCLC survivorship care comprising a power point presentation reviewing evidence and guidelines; a USB drive of the NCCN guidelines with paper copy of pages addressing survivorship care; an electronic and paper copy of a sample survivorship clinic template note with prompts for addressing survivorship care components; and an electronic paper copy sample survivorship care plan that can be adapted and distributed at each participating site.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Lung, Mucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum, Signet Ring Adenocarcinoma of the Colon, Signet Ring Adenocarcinoma of the Rectum, Squamous Cell Lung Cancer, Stage I Colon Cancer, Stage I Rectal Cancer, Stage IA Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIA Colon Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIA Rectal Cancer, Stage IIB Colon Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIB Rectal Cancer, Stage IIC Colon Cancer, Stage IIC Rectal Cancer, Stage IIIA Colon Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIA Rectal Cancer, Stage IIIB Colon Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IIIB Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1440 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health services research (educational intervention)
Arm Type
Experimental
Arm Description
Health care providers complete an educational intervention based on NCCN guidelines in CRC and NSCLC survivorship care comprising a power point presentation reviewing evidence and prompts for addressing survivorship care components; and an electronic paper copy sample survivorship care plan that can be adapted and distributed at each participating site.
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Complete an educational intervention based on NCCN guidelines and disease-specific issues related to survivorship care
Intervention Type
Other
Intervention Name(s)
medical chart review
Other Intervention Name(s)
chart review
Intervention Description
Complete patient medical chart audit
Primary Outcome Measure Information:
Title
Percentage of eligible CRC and NSCLC survivors with medical record documentation of compliance with NCCN guidelines
Description
A test of the binomial proportion will have 99% power with 1% type I error to make this distinction.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Change in percentage of eligible survivors with documentation of compliance with NCCN survivorship guidelines after conducting the targeted educational initiative at participating sites
Description
This two-sample test of binomial proportions will have 99% power with 1% type I error.
Time Frame
Baseline and up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HEALTH CARE PROVIDER INCLUSION CRITERIA: Any health care provider (physician, advanced practice clinician) at a study site (Fox Chase Cancer Center [FCCC] and Fox Chase Cancer Center Partners [FCCCP]) who provides care for NSCLC and/or CRC survivors CHART AUDIT INCLUSION CRITERIA (BASELINE): Cancer Registry cases include stage I-III colon cancer (adenocarcinoma histology), stage I-III rectal cancer (adenocarcinoma histology), stage I-III non-small cell lung cancer (squamous or adenocarcinoma histology) Patients must have completed all therapy for curative intent at least six months prior to chart audit Undergoing routine oncology care and surveillance at the chosen site (defined as receiving follow-up care with FCCC or FCCCP site health care providers and have an active medical chart) No evidence of metastatic disease Patients must have been seen for a visit for cancer surveillance between 2009 and 2013 Health care providers at the participating site must be willing and able to participate in the educational initiative CHART AUDIT INCLUSION CRITERIA (POST-INTERVENTION) Charts eligible for audit after completion of the educational initiative will be for those CRC and NSCLC survivors presenting for follow-up after the initiative has been completed by site health care providers Exclusion Criteria: CHART AUDIT EXCLUSION CRITERIA: Cancer Registry cases for diseases other than colon or rectal adenocarcinoma and non-small cell lung cancer (squamous or adenocarcinoma histology) Patients currently receiving active therapy for any cancer, including CRC or NSCLC Patients who do not undergo routine oncologic care at the chosen Partners site or Fox Chase Cancer Center Stage IV cancer or evidence of metastatic disease at any time point Patients who have not undergone a visit for cancer surveillance since 2009 Fox Chase Cancer Partners sites who do not agree to chart audit procedures or providers are unable or unwilling to participate in the educational initiative
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Crystal Denlinger, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Adherence to Survivorship Care Guidelines in Health Care Providers for Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care

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