NCT01726296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

April 6, 2017

Status Verified

November 1, 2016

Enrollment Period

2.5 years

First QC Date

November 9, 2012

Last Update Submit

April 5, 2017

Conditions

Adenocarcinoma of the LungMucinous Adenocarcinoma of the ColonMucinous Adenocarcinoma of the RectumSignet Ring Adenocarcinoma of the ColonSignet Ring Adenocarcinoma of the RectumSquamous Cell Lung CancerStage I Colon CancerStage I Rectal CancerStage IA Non-small Cell Lung CancerStage IB Non-small Cell Lung CancerStage IIA Colon CancerStage IIA Non-small Cell Lung CancerStage IIA Rectal CancerStage IIB Colon CancerStage IIB Non-small Cell Lung CancerStage IIB Rectal CancerStage IIC Colon CancerStage IIC Rectal CancerStage IIIA Colon CancerStage IIIA Non-small Cell Lung CancerStage IIIA Rectal CancerStage IIIB Colon CancerStage IIIB Non-small Cell Lung CancerStage IIIB Rectal CancerStage IIIC Colon CancerStage IIIC Rectal Cancer

Outcome Measures

Primary Outcomes (1)

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

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

    Up to 6 months

Secondary Outcomes (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

Study Arms (1)

Health services research (educational intervention)

EXPERIMENTAL

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 interventionOther: medical chart review

Interventions

educational interventionOTHER

Complete an educational intervention based on NCCN guidelines and disease-specific issues related to survivorship care

Also known as: intervention, educational
Health services research (educational intervention)
medical chart reviewOTHER

Complete patient medical chart audit

Also known as: chart review
Health services research (educational intervention)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Adenocarcinoma of LungColonic NeoplasmsRectal NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Early Intervention, EducationalMethods

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesInvestigative Techniques

Study Officials

  • Crystal Denlinger, MD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2012

First Posted

November 14, 2012

Study Start

January 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

April 6, 2017

Record last verified: 2016-11

Locations

US(1)