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

April 5, 2017 updated by: Fox Chase Cancer Center

Adherence to NCCN Survivorship Care Guidelines in Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Health services research (educational intervention)
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.
Other: educational intervention
Complete an educational intervention based on NCCN guidelines and disease-specific issues related to survivorship care
Other Names:
  • intervention, educational
Other: medical chart review
Complete patient medical chart audit
Other Names:
  • chart review

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of eligible CRC and NSCLC survivors with medical record documentation of compliance with NCCN guidelines
Time Frame: Up to 6 months
A test of the binomial proportion will have 99% power with 1% type I error to make this distinction.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in percentage of eligible survivors with documentation of compliance with NCCN survivorship guidelines after conducting the targeted educational initiative at participating sites
Time Frame: Baseline and up to 6 months
This two-sample test of binomial proportions will have 99% power with 1% type I error.
Baseline and up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fox Chase Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

November 9, 2012

First Submitted That Met QC Criteria

November 9, 2012

First Posted (ESTIMATE)

November 14, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-841
  • NCI-2012-01717 (REGISTRY: NCI CTRP Registration Site)

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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