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


N/A
18 Years
N/A
Open (Enrolling)
Both
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

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

Percentage of eligible CRC and NSCLC survivors with medical record documentation of compliance with NCCN guidelines

Outcome Description:

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

Outcome Time Frame:

Up to 6 months

Safety Issue:

No

Principal Investigator

Crystal Denlinger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

12-841

NCT ID:

NCT01726296

Start Date:

January 2013

Completion Date:

Related Keywords:

  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Cystadenocarcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Neoplasms
  • Lung Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111