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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01726296
First Posted: November 14, 2012
Last Update Posted: April 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fox Chase Cancer Center
  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: 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

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


Enrollment: 1440
Study Start Date: January 2013
Study Completion Date: July 2015
Primary Completion Date: July 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726296


Locations
United States, Pennsylvania
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
  More Information

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT01726296     History of Changes
Other Study ID Numbers: 12-841
NCI-2012-01717 ( Registry Identifier: NCI CTRP Registration Site )
First Submitted: November 9, 2012
First Posted: November 14, 2012
Last Update Posted: April 6, 2017
Last Verified: November 2016

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