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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Fox Chase Cancer Center
Sponsor:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT01726296
First received: November 9, 2012
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
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
Other: educational intervention
Other: medical chart review

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • Percentage of eligible CRC and NSCLC survivors with medical record documentation of compliance with NCCN guidelines [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
    This two-sample test of binomial proportions will have 99% power with 1% type I error.


Estimated Enrollment: 1440
Study Start Date: January 2013
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: intervention, educational
Other: medical chart review
Complete patient medical chart audit
Other Name: chart review

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726296

Contacts
Contact: Crystal Denlinger, MD 215-214-1676 crystal.denlinger@fccc.edu

Locations
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Crystal Denlinger, MD    215-214-1676    crystal.denlinger@fccc.edu   
Principal Investigator: Crystal Denlinger, MD         
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Principal Investigator: Crystal Denlinger, MD Fox Chase Cancer Center
  More Information

No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT01726296     History of Changes
Other Study ID Numbers: 12-841, NCI-2012-01717
Study First Received: November 9, 2012
Last Updated: January 31, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Adenocarcinoma, Mucinous
Colonic Neoplasms
Colorectal Neoplasms
Cystadenocarcinoma
Lung Neoplasms
Rectal Neoplasms
Bronchial Neoplasms
Carcinoma
Carcinoma, Bronchogenic
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Glandular and Epithelial
Rectal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014