Adenocarcinoma of the LungNCT01726296
Adherence to Survivorship Care Guidelines in Health Care Providers for Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care
A study testing educational intervention and medical chart review in people with Adenocarcinoma of the Lung and Mucinous Adenocarcinoma of the Colon, run by Fox Chase Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Lung, Mucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum
- What is being tested?
- educational intervention and medical chart review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Adherence to NCCN Survivorship Care Guidelines in Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- 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
- Being tested
- educational intervention, medical chart review
- Medical subject headings
- Adenocarcinoma of Lung, Colonic Neoplasms, Rectal Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
Also called intervention, educational
Complete an educational intervention based on NCCN guidelines and disease-specific issues related to survivorship care
medical chart reviewOther
Also called chart review
Complete patient medical chart audit
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: educational intervention; Other: medical chart review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
This two-sample test of binomial proportions will have 99% power with 1% type I error.
Measured: Baseline and up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the LungStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Crystal Denlinger, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726296
- Sponsor's protocol ID
- 12-841
- Other IDs
- NCI-2012-01717
- Status last verified
- Nov 2016
- First submitted
- 9 Nov 2012
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to NCCN Survivorship Care Guidelines in Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care
- ClinicalTrials.gov ID
- NCT01726296
- Acronym / sponsor ID
- 12-841
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,440 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health services research (educational intervention) | Experimental | Other: educational intervention, Other: medical chart reviewHealth 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational interventionAlso: intervention, educationalComplete an educational intervention based on NCCN guidelines and disease-specific issues related to survivorship care | Other | Health services research (educational intervention) |
| medical chart reviewAlso: chart reviewComplete patient medical chart audit | Other | Health services research (educational intervention) |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crystal Denlinger, MD principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention and medical chart review in people with Adenocarcinoma of the Lung and Mucinous Adenocarcinoma of the Colon, run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of eligible CRC and NSCLC survivors with medical record documentation of compliance with NCCN guidelines (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.