Colon CancerNCT02112747
Adherence to Colon Cancer Screening (ACCS)
A study testing Patient Navigator in people with Colon Cancer and Rectal Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This randomized clinical trial studies website access or genetic counseling with or without patient navigators on adherence to colorectal cancer screening recommendations in patients with newly diagnosed colorectal cancer and their first degree relatives. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- What is being tested?
- Patient Navigator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,900 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 31 Dec 2020
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Newly diagnosed with colorectal adenocarcinoma at Ohio State University (OSU) (or a participating Ohio hospital) with sufficient tumor available to perform the microsatellite instability (MSI) test, regardless of age at diagnosis or family history
- First-degree relatives of the cases who test positive for LS
- First-degree relatives of the cases who test negative for LS
Who cannot join
- Pregnant women
- Prisoners
- Individuals who are cognitively impaired
Trial locations and contacts
1 site in 1 country.
United States1 site
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Ohio Colorectal Cancer Prevention Initiative: Adherence to Colon Cancer Screening (ACCS) Project:Your Personal Prescription For Colorectal Cancer Screening.
This randomized clinical trial studies website access or genetic counseling with or without patient navigators on adherence to colorectal cancer screening recommendations in patients with newly diagnosed colorectal cancer and their first degree relatives. Websites for colorectal cancer prevention and genetic counseling may be effective methods to help people learn about cancer screening. Patient navigators may improve adherence to colorectal cancer screening recommendations. It is not yet known whether website access or genetic counseling is more effective with or without patient navigators.
Read the detailed description
PRIMARY OBJECTIVES:
- Test the comparative-effectiveness of the interventions (i.e., website +/- navigator or genetic counseling +/- navigator) in a randomized controlled trial, using colorectal cancer (CRC) cases as the unit of randomization/analysis on adherence to individualized CRC screening recommendations.
SECONDARY OBJECTIVES:
- Examine the cost effectiveness of the interventions, assessing the effect of the interventions on subgroups (i.e., Lynch syndrome positive vs. Lynch syndrome negative; probands vs. relatives; older vs. younger patients, etc), and barriers to adherence, as well as how the navigators resolve barriers.
II. Overscreening will be explored.
OUTLINE: Participants are assigned to 1 of 2 study components based on LS status. Within each component, participants are randomized to 1 of 2 arms.
COMPONENT #1 (Lynch Negative Proband and their first degree relatives (FDRs):
ARM I: Participants access a website to deliver a "personalized prescription for CRC prevention" based on age, Lynch Syndrome status, cancer history, age of 1st degree relative with CRC, and personal CRC screening history.
ARM II: Participants access a website as in Arm I and receive the services of a patient navigator to address individual barriers to adhering to the "personal prescription" within 1 month.
COMPONENT #2 (Lynch Positive Proband and their FDRs):
ARM III (Lynch positive proband): Participants use genetic counseling to discuss medical and family history and genetic risk of CRC, including genetic factors such as deoxyribonucleic acid (DNA) mismatch repair genes, autosomal dominant inheritance, cancer risks associated with LS, screening recommendations, and genetic testing.
ARM IV (Lynch positive proband): Participants use genetic counseling as in Arm III and receive the services of a patient navigator to address individual barriers to adhering to the CRC screening recommendations within 1 month.
After completion of study treatment, patients are followed up at 12-14 months.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- Patient Navigator
- Keywords
- Colorectal Cancer Prevention, Colorectal Cancer Screening, ACCS, Lynch Syndrome, LS
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigatorOther
Patients are randomized to receive the assistance of a patient navigator to understand, obtain assistance with following the screening recommendations of the personal prescription given to them by the website survey.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: website access only | No intervention | There is no intervention with this arm. Completion of the website is part of enrollment. |
| Arm 2: patient navigator | Experimental | The intervention consists of participants receiving the services of a patient navigator to address individual barriers to adhering to the "personal prescription" for colon and rectal cancer screening. Receives: Other: Patient Navigator |
| Arm 3: genetic counseling | No intervention | There is no intervention in this arm. Patients diagnosed as positive for Lynch Syndrome use genetic counseling to discuss medical and family history and genetic risk of CRC, including genetic factors such as DNA mismatch repair genes, autosomal dominant inheritance, cancer risks associated with LS, screening recommendations, and genetic testing. There is no intervention. This is standard care. |
| Arm 4:Gen. counselor & patient navigator | Experimental | Participants diagnosed positive for Lynch syndrome use genetic counseling as in Arm 3 and in addition receive the services of a patient navigator to address individual barriers to adhering to the CRC screening recommendations. Receives: Other: Patient Navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successfully following screening guidelines appropriate to the participant's risk profile
For participants who are within the recommended guidelines, success would be defined as receiving no further screening. For those outside of the recommended guidelines, success would entail receiving a screening test. The outcome will combine medical record review and self-report by using medical record review when available and self-report otherwise. Evaluations will use a generalized estimating equations (GEE) approach with empirical sandwich variance estimators.
Measured: Up to 14 months
Secondary outcomes (1)
Cost effectiveness of the interventions
Analysis will consist of a cost analysis of the intervention incorporating project expenditures and both financial and non-financial costs incurred by the project participants. Financial benefits from the project will be incorporated into the cost analysis to produce a net cost of the interventions. These financial benefits will include expenditures for unnecessary or "overscreening" prevented by the interventions. The results of the net cost analysis will be combined with the outcome measures for screening interventions to establish the cost per guideline concordant screening.
Measured: Up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startSep 2013
- Primary completion31 Dec 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,900 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Electra Paskett, Ohio State University Comprehensive Cancer Center
- Investigators
- Electra Paskett, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112747
- Sponsor's protocol ID
- OSU-12230
- Other IDs
- NCI-2013-01146
- Status last verified
- Mar 2021
- First submitted
- 10 Apr 2014
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paskett ED, Bernardo BM, Young GS, Katz ML, Reiter PL, Tatum CM, Oliveri JM, DeGraffinreid CR, Gray DM, Pearlman R, Hampel H. Comparative Effectiveness of Two Interventions to Increase Colorectal Cancer Screening for Those at Increased Risk Based on Family History: Results of a Randomized Trial. Cancer Epidemiol Biomarkers Prev. 2020 Jan;29(1):3-9. doi: 10.1158/1055-9965.EPI-19-0797. Epub 2019 Oct 30.
PubMed 31666284
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ohio Colorectal Cancer Prevention Initiative: Adherence to Colon Cancer Screening (ACCS) Project:Your Personal Prescription For Colorectal Cancer Screening.
- ClinicalTrials.gov ID
- NCT02112747
- Acronym / sponsor ID
- OSU-12230
- Conditions
- Colon Cancer, Rectal Cancer
- Keywords
- Colorectal Cancer Prevention, Colorectal Cancer Screening, ACCS, Lynch Syndrome, LS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,900 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 14 Apr 2014 (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 randomized clinical trial studies website access or genetic counseling with or without patient navigators on adherence to colorectal cancer screening recommendations in patients with newly diagnosed colorectal cancer and their first degree relatives. Websites for colorectal cancer prevention and genetic counseling may be effective methods to help people learn about cancer screening. Patient navigators may improve adherence to colorectal cancer screening recommendations. It is not yet known whether website access or genetic counseling is more effective with or without patient navigators.
Detailed description
PRIMARY OBJECTIVES:
- Test the comparative-effectiveness of the interventions (i.e., website +/- navigator or genetic counseling +/- navigator) in a randomized controlled trial, using colorectal cancer (CRC) cases as the unit of randomization/analysis on adherence to individualized CRC screening recommendations.
SECONDARY OBJECTIVES:
- Examine the cost effectiveness of the interventions, assessing the effect of the interventions on subgroups (i.e., Lynch syndrome positive vs. Lynch syndrome negative; probands vs. relatives; older vs. younger patients, etc), and barriers to adherence, as well as how the navigators resolve barriers.
II. Overscreening will be explored.
OUTLINE: Participants are assigned to 1 of 2 study components based on LS status. Within each component, participants are randomized to 1 of 2 arms.
COMPONENT #1 (Lynch Negative Proband and their first degree relatives (FDRs):
ARM I: Participants access a website to deliver a "personalized prescription for CRC prevention" based on age, Lynch Syndrome status, cancer history, age of 1st degree relative with CRC, and personal CRC screening history.
ARM II: Participants access a website as in Arm I and receive the services of a patient navigator to address individual barriers to adhering to the "personal prescription" within 1 month.
COMPONENT #2 (Lynch Positive Proband and their FDRs):
ARM III (Lynch positive proband): Participants use genetic counseling to discuss medical and family history and genetic risk of CRC, including genetic factors such as deoxyribonucleic acid (DNA) mismatch repair genes, autosomal dominant inheritance, cancer risks associated with LS, screening recommendations, and genetic testing.
ARM IV (Lynch positive proband): Participants use genetic counseling as in Arm III and receive the services of a patient navigator to address individual barriers to adhering to the CRC screening recommendations within 1 month.
After completion of study treatment, patients are followed up at 12-14 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: website access only | No intervention | –There is no intervention with this arm. Completion of the website is part of enrollment. |
| Arm 2: patient navigator | Experimental | Other: Patient NavigatorThe intervention consists of participants receiving the services of a patient navigator to address individual barriers to adhering to the "personal prescription" for colon and rectal cancer screening. |
| Arm 3: genetic counseling | No intervention | –There is no intervention in this arm. Patients diagnosed as positive for Lynch Syndrome use genetic counseling to discuss medical and family history and genetic risk of CRC, including genetic factors such as DNA mismatch repair genes, autosomal dominant inheritance, cancer risks associated with LS, screening recommendations, and genetic testing. There is no intervention. This is standard care. |
| Arm 4:Gen. counselor & patient navigator | Experimental | Other: Patient NavigatorParticipants diagnosed positive for Lynch syndrome use genetic counseling as in Arm 3 and in addition receive the services of a patient navigator to address individual barriers to adhering to the CRC screening recommendations. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly diagnosed with colorectal adenocarcinoma at Ohio State University (OSU) (or a participating Ohio hospital) with sufficient tumor available to perform the microsatellite instability (MSI) test, regardless of age at diagnosis or family history
- First-degree relatives of the cases who test positive for LS
- First-degree relatives of the cases who test negative for LS
Key exclusion criteria (3 listed)
- Pregnant women
- Prisoners
- Individuals who are cognitively impaired
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 |
|---|---|---|
| Patient NavigatorPatients are randomized to receive the assistance of a patient navigator to understand, obtain assistance with following the screening recommendations of the personal prescription given to them by the website survey. | Other | Arm 2: patient navigator, Arm 4:Gen. counselor & patient navigator |
Primary outcome
Successfully following screening guidelines appropriate to the participant's risk profile
Time frame: Up to 14 months
For participants who are within the recommended guidelines, success would be defined as receiving no further screening. For those outside of the recommended guidelines, success would entail receiving a screening test. The outcome will combine medical record review and self-report by using medical record review when available and self-report otherwise. Evaluations will use a generalized estimating equations (GEE) approach with empirical sandwich variance estimators.
1 secondary outcome
Cost effectiveness of the interventions
Time frame: Up to 14 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 10 Mar 2021.
- Derived from this study: PubMed 31666284Paskett ED, Bernardo BM, Young GS, Katz ML, Reiter PL, Tatum CM, Oliveri JM, DeGraffinreid CR, Gray DM, Pearlman R, Hampel H. Comparative Effectiveness of Two Interventions to Increase Colorectal Cancer Screening for Those at Increased Risk Based on Family History: Results of a Randomized Trial. Cancer Epidemiol Biomarkers Prev. 2020 Jan;29(1):3-9. doi: 10.1158/1055-9965.EPI-19-0797. Epub 2019 Oct 30.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Electra Paskett principal investigator
Ohio State University Comprehensive 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 Patient Navigator in people with Colon Cancer and Rectal Cancer, run by Ohio State University Comprehensive 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 3 inclusion and 3 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 10 Mar 2021. 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?
Successfully following screening guidelines appropriate to the participant's risk profile (time frame: Up to 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02112747, which also lists 1 linked publication.
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 10 Mar 2021.