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

Sponsor
Fox Chase Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT01726296
Collaborator
(none)
1,440
1
1
29.9
48.1

Study Details

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:
  1. 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:
  1. 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.

  2. 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 Design

Study Type:
Interventional
Actual Enrollment :
1440 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Adherence to NCCN Survivorship Care Guidelines in Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of eligible CRC and NSCLC survivors with medical record documentation of compliance with NCCN guidelines [Up to 6 months]

      A test of the binomial proportion will have 99% power with 1% type I error to make this distinction.

    Secondary Outcome Measures

    1. Change in percentage of eligible survivors with documentation of compliance with NCCN survivorship guidelines after conducting the targeted educational initiative at participating sites [Baseline and up to 6 months]

      This two-sample test of binomial proportions will have 99% power with 1% type I error.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111

    Sponsors and Collaborators

    • Fox Chase Cancer Center

    Investigators

    • Principal Investigator: Crystal Denlinger, MD, Fox Chase Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fox Chase Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01726296
    Other Study ID Numbers:
    • 12-841
    • NCI-2012-01717
    First Posted:
    Nov 14, 2012
    Last Update Posted:
    Apr 6, 2017
    Last Verified:
    Nov 1, 2016

    Study Results

    No Results Posted as of Apr 6, 2017