FIT Mailing Protocol-For Cancer Screening Navigation

2016-10-18 02:08:21 | BioPortfolio


We plan to study whether the impact of offering the choice of a pre-colonoscopy physician visit or direct referral to colonoscopy will increase adherence to colonoscopy relative to usual care in a large fecal immunochemical test (FIT) mailing campaign.

We will evaluate two study options, usual care during which patients will be required to have an office visit with wither a PCP or a Gastroenterologist prior to being scheduled for a colonoscopy, or a choice where patients will be given the option of a pre-colonoscopy visit with a gastroenterologist or PCP vs. direct referral for a colonoscopy.

In these two options we will examine colonoscopy adherence, adequacy of triage, patient satisfaction, colonoscopy outcomes (no show rate, prep quality, and pain during colonoscopy) and how insurance coverage, gender, race, education or patient understanding of colon cancer screening message during the navigation process might impact outcomes.


A total of 13,392 patients will be invited to participate in the study. Approximately 2500 patients will be enrolled in the study every month for 4 months. This sampling plan will enable sufficient statistical power (at least .80) to conduct the analyses of the objectives using logistic regression.

At the time of enrollment into the study, an educational brochure and a letter will be sent to all potential participants advising them that they may not be up to date in colon cancer screening and that they will be receiving a free FIT test in the mail in a couple weeks. The letter will advise them that they will be participating in a study that Renown is doing to improve the ability to diagnose early colon cancer and that they will be contacted by Renown with their results and also any additional recommendations if the FIT is positive. If they have questions or do not want to participate, there is a number for potential participants to call for more information or to opt out. Patients that choose not to participate in the study who would still like to complete the FIT screening kit, will be informed that they will be responsible to pay for the FIT test (about $25) following Renown's standard operating procedures.

2 weeks after the initial letter, all newly enrolled patients will receive a mailing including a FIT test, an educational brochure, instructions on how to collect the FIT test and a Thank You letter for participating.

An initial automated telephone message will be left for each patient at the time of the mailing reminding them to submit their stool FIT. At 2 and 3 weeks after the FIT mailing all patients medical records will be reviewed and those who have not yet returned their stool FIT will receive an automated telephone call reminder to mail in their stool FIT.

At 4 weeks all patients who have not yet returned their stool FIT will be contacted by phone and those that are able to be reached and agree to submit the stool FIT will be mailed a 2nd stool FIT if needed. If the stool FIT is not submitted by 2 months of the mailing, the patient will be listed as not returning a FIT.

All patients who have returned a stool FIT with a negative result will be provided their results by letter.

The patients PCP will be also provided the positive or negative results by letter.

All patients with a positive stool FIT will be randomized into either Usual Care or Choice study groups. The two study groups will be matched by gender, race/ethnicity, Spanish-speakers, and rural/urban location.

Patients in Group 1 (Usual Care) who have a positive result will be contacted by phone by the Nurse Navigator with their results, receive some education about the significance of a + stool FIT relative to colon cancer screening and advised to make an appointment with a PCP or Gastroenterologist to discuss the results and possibly be referred for colonoscopy. If they do not have a PCP they will receive assistance in being referred to one. They will be asked to complete a telephone questionnaire that explores patient demographics (education, race, income, prior colonoscopy etc) in Spanish or English. Patients' EPIC electronic medical records will be monitored to see if they have made an appointment within 2 days of getting their results. If not, they will receive 2 attempted live telephone reminders followed by a certified letter. If a patient is referred to a GI consult, and fails to schedule an appointment within 1 month, GI will notify the patients Renown PCP of the failed appointment.

Patients in Group 1 with a positive result who cannot be reached by phone will receive a certified letter with their results with instructions to contact the Study Navigator to arrange further testing.

Patients in Group 2 (Choice) who have a positive FIT result will be contacted by phone by the Nurse Navigator with their results, receive some education about the significance of a + stool FIT relative to colon cancer screening and given the choice to either schedule an appointment with a PCP or Gastroenterologist to discuss their results, or will receive direct referral to Gastroenterology Consultants for a colonoscopy. They will be asked to complete a telephone questionnaire that explores patient demographics (education, race, income, prior colonoscopy) in Spanish or English. Patients will then receive assistance and monitoring as in that described above for Group 1 depending upon whether they are referred for an office visit/consultation vs. a direct referral for a colonoscopy.

Patients in Group 2 with a positive result who cannot be reached by phone will receive a certified letter with their results with instructions to contact the Study Navigator to arrange further testing.

Patients who are referred directly for a colonoscopy will be contacted by phone by a scheduler at Gastroenterology Consultants and be asked questions to determine the best bowel preparation and sedation for them (conscious sedation with fentanyl and versed vs. propofol, and to insure that the patient has no significant co-morbidities that might require a pre-colonoscopy visit for medical assessment (anticoagulants, severe lung disease, recent MI, bleeding disorder).

Additionally, those that are referred for a direct colonoscopy and fail to schedule or show for their appointment will be referred back to the Renown Nurse Navigator for 2 attempts at a live call then a certified letter.

All patients in group 2 who have not yet had a colonoscopy 6 months after they were initially given their results will again be contacted by phone by a Navigator and again encouraged to have colonoscopy or at minimum to discuss the procedure/FIT results with either their physician or a Gastroenterologist and be offered assistance to schedule those appointments.

Patients in both groups will have 1 year from the date their initial FIT test is mailed to obtain a colonoscopy as recorded in the EPIC EMR.

All patients with a positive stool FIT who have completed the study either by having a colonoscopy or by not having a colonoscopy at the end of the study period will be mailed a questionnaire assessing various quality parameters of the colon cancer screening experience with a stamped self addressed envelope for return and Thank You letter for their participation including a $10 Amazon gift certificate as a token of appreciation for their time. If the questionnaire is not returned within 2 weeks, they will be sent a 2nd questionnaire and reminder letter. After 2 more weeks, if the questionnaire is not returned the research assistant will contact the patient to offer the choice to complete the survey over the telephone.

To accommodate Spanish speaking only patients, all documents mailed to patients will be written both in English and Spanish versions and Spanish translators will be available to speak with patients by phone to respond to questions or to go over the questionnaires.

Other Items A script will be used for any participants who call with questions (see "Script if participant calls").

To protect participant's identity, only de-identified data will be reviewed by the UNR co-investigator (Paul Devereux). The de-identified data will be stored on a password-protected computer in Paul Devereux's locked office. The data will be transferred to Paul Devereux using a password-protected USB flash drive. Data will not contain, names, addresses, dates of birth, or Renown ID numbers.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening


Colorectal Neoplasms


Colon Cancer Screening Navigation, Standard of Care


Renown Regional Medical Center
United States


Active, not recruiting


Renown Regional Medical Center

Results (where available)

View Results


Published on BioPortfolio: 2016-10-18T02:08:21-0400

Clinical Trials [6011 Associated Clinical Trials listed on BioPortfolio]

Study of Patient Navigation to Promote Colon Cancer Screening

This study will investigate whether patient navigation can increase rates of colorectal cancer screening among linguistically and culturally diverse disadvantaged patients served by urban ...

Improving Comprehensive Cancer Screening Among Vulnerable Patients Using Patient Navigation

Patient navigation (PN) has been shown to improve rates of cancer screening in vulnerable populations. Most cancer PN programs are located in community health centers and focus on a single...

Comparing Interventions to Increase Colorectal Cancer Screening

The purpose of this study is to test different approaches to help people understand the purpose of colorectal cancer (CRC) screening, two screening test options available, and the barriers...

Unprepped CT Colonography

It is our objective to improve the performance of CTC in the prepared colon, and to validate CTC in the unprepared colon for the detection of colorectal neoplasia. The cost-effectiveness ...

Initiation of Colon Cancer Screening in Veterans or "Start Screening Now"

Initiation of colon cancer screening in veterans is a theory-based stepped intervention to increase first time colorectal cancer screening (CRCS) among male and female veterans age 50 and ...

PubMed Articles [30446 Associated PubMed Articles listed on BioPortfolio]

The Effects of the Nurse Navigation Program in Promoting Colorectal Cancer Screening Behaviors: a Randomized Controlled Trial.

Although screening programs are known and recommended for the early detection of colorectal cancer (CRC), the screening rates for the fecal occult blood test (FOBT) and colonoscopy are very low among ...

Effect of Medicaid Expansion on Colorectal Cancer Screening Rates.

Colorectal cancer screening decreases incidence and improves survival. Minorities and low-income patients have lower screening rates. The Affordable Care Act increased insurance coverage for low-incom...

Flexible sigmoidoscopy in colorectal cancer screening: implications of different colonoscopy referral strategies.

Flexible sigmoidoscopy (FS) screening reduces colorectal cancer incidence and mortality. Its potential to detect proximal neoplasms depends on colonoscopy referral. We estimated diagnostic performance...

The impact of the rising colorectal cancer incidence in young adults on the optimal age to start screening: Microsimulation analysis I to inform the American Cancer Society colorectal cancer screening guideline.

In 2016, the Microsimulation Screening Analysis-Colon (MISCAN-Colon) model was used to inform the US Preventive Services Task Force colorectal cancer (CRC) screening guidelines. In this study, 1 of 2 ...

Economic assessment of patient navigation to colonoscopy-based colorectal cancer screening in the real-world setting at the University of Chicago Medical Center.

This report details the cost effectiveness of a non-nurse patient navigation (PN) program that was implemented at the University of Chicago Medical Center to increase colonoscopy-based colorectal canc...

Medical and Biotech [MESH] Definitions

Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.

A group of autosomal-dominant inherited diseases in which COLON CANCER arises in discrete adenomas. Unlike FAMILIAL POLYPOSIS COLI with hundreds of polyps, hereditary nonpolyposis colorectal neoplasms occur much later, in the fourth and fifth decades. HNPCC has been associated with germline mutations in mismatch repair (MMR) genes. It has been subdivided into Lynch syndrome I or site-specific colonic cancer, and LYNCH SYNDROME II which includes extracolonic cancer.

Tumor suppressor genes located in the 5q21 region on the long arm of human chromosome 5. The mutation of these genes is associated with the formation of colorectal cancer (MCC stands for mutated in colorectal cancer).

Tumors or cancer of the COLON.

Tumor suppressor genes located in the 18q21-qter region of human chromosome 18. The absence of these genes is associated with the formation of colorectal cancer (DCC stands for deleted in colorectal cancer). The products of these genes show significant homology to neural cell adhesion molecules and other related cell surface glycoproteins.

More From BioPortfolio on "FIT Mailing Protocol-For Cancer Screening Navigation"

Quick Search


Relevant Topics

Pain Disorder
Pain is a feeling (sharp or dull) triggered in the nervous system which can be transient or constant. Pain can be specific to one area of the body eg back, abdomen or chest or more general all over the body eg muscles ache from the flu. Without pain ...

Colorectal Cancer
Colon or Colorectal cancer is the growth of malignant polyps on the colon, bowel, anus and rectum. Growths in these locations can be benign, and removed by colonoscopy, but they have a risk of becoming malignant.  About 10 per cent of bowel cancer...

Searches Linking to this Trial