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.
Verified April 2013 by Fox Chase Cancer Center
Sponsor:
Fox Chase Cancer Center
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT01726296
First received: November 9, 2012
Last updated: April 15, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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: | April 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lung Neoplasms Adenocarcinoma Adenocarcinoma, Mucinous Colonic Neoplasms Rectal Neoplasms Cystadenocarcinoma Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Intestinal Neoplasms |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013