Trial Information

Navigation From Community to Clinic to Promote CRC Screening in Underserved Populations

Design overview:

This study will employ a 2-phase experimental, randomized design to test a community to
clinic navigation intervention: (1) to increase attendance at primary care clinics (Phase
I), and (2) to track CRC screening among those who visit clinics (Phase II). The
investigators will recruit non-adherent individuals from multicultural community sites in
low-income zip codes in the Phoenix Arizona metropolitan area.

In Phase I, community sites will be randomized to either group education (GE) or group
education plus tailored navigation (GE +TN) to increase attendance at the primary care
clinics. In Phase II, individuals who complete a clinic appointment (from Phase I) will then
receive the standard of care (provider prompts, navigation calls to patients) in the clinic.
Phase I brings individuals into the primary care system (clinic attendance), and Phase II
follows them through to CRC screening completion (either stool-based or colonoscopy). An
accelerated plan will be initiated for individuals identified as at high risk for CRC,
referring them for colonoscopy, to realistically evaluate effects of the interventions in
real-world conditions, including the range of patient risk profiles in this setting.
Recruitment, intervention, and data collection materials have been developed in English and
Spanish and reviewed by a Cultural Community Advisory Board (CCAB) for cultural fit across
our multicultural population of low-income participants.

Intervention details:

Group education (Phase I): Groups will be assembled for an educational class after all
baseline surveys are completed for a community site. The curriculum for the 60 minute class
will include:

- general information on cancer risk,

- specific risk factors for CRC,

- brief review of dietary and physical activity guidelines,

- stool blood test: purpose, preparation, and procedures(emphasis on the fecal occult
blood test-- FOBT-- and FIT test),

- requirements and reasons for annual testing,

- meaning of results, and importance of follow-up for positive tests,

- instructions and sample kit discussion

- colonoscopy discussion,

- preventative potential when polyps are removed,

- colonoscopy preparation,

- anesthesia,

- guidelines regarding use of colonoscopy as the primary screening tool for individuals
at higher risk, and for those who test positive on stool-based screening will be
discussed

Tailored navigation (TN) Phase I: Participants randomized to the groups receiving GE + TN
intervention will be called within 5 days of the completion of the class and will be
encouraged to schedule an appointment at the nearby identified clinic. Trained, culturally
sensitive navigators will navigate participants through their individual barriers and
concerns, using the tailored set of responses from the message library (with a
multi-theoretical basis) developed in the co-PI's previous research (R21CA100566;PI:Menon &
R01NR8425; PI: Menon). Calls will continue, for a total of 5 within an 8-week period (or
less, if attendance to clinic and/or adherence to screening are obtained). In whichever call
becomes the final, Tracking Questions will be administered to assess the status of clinic
attendance or reasons for not scheduling or keeping a clinic appointment (with the same data
collected at the end of 8 weeks for non-navigated control group participants).

Tailored navigation (TN) Phase II will utilize the full message library to assist patients
to overcome barriers to care, negotiate healthcare systems, and access quality care. Within
each clinic, an existing trained, staff member(or study navigator) will follow up on the
patients who attend a clinic appointment.

Although patient navigators vary by site, the primary role of the clinic-based navigator
includes connecting patients to resources and support systems; assisting in communication
with clinic providers and staff; streamlining appointments and paperwork; helping patients
identify and access financial services, basic counseling on psychosocial issues such as
fear, anxiety, appropriate social services; and tracking all interactions and outcomes. Our
TN will cover all these components in the proposed study. Calls will continue for a total of
5 within an 8-week period.

Control conditions clarification. In Phase I, participants in the control arm of the study
will receive 3 calls designed to support data collection and tracking, but will not receive
navigation messages. Call 1: 1-2 weeks after the initial clinic visit to verify contact
information; Call 2: during weeks 5-6 to inquire if a clinic appointment was made and kept
and to schedule data collection call for week 8 (Call 3). Call 3 (or earlier, if clinic was
attended) will utilize the Tracking survey to document clinic attendance or reasons for
non-attendance. During any call if an appointment was made and kept, the clinic name and
provider visited will be documented, and the patient will be followed through Phase II.

Data Collection:

Eligibility status will be determined using initial screening questions. Participants who we
determine to be ineligible will be thanked for their time, encouraged to continue with CRC
screening annually (or on whatever schedule appropriate based on risk status, age and type
of screening obtained). Those who are eligible will be administered the study consent.
Consent procedures will inform participants the purpose and details of the study.

Once participants are consented, they will be interviewed for baseline data collection. The
demographic data to be collected at baseline and confirmed (repeated) if participants appear
in clinics for Phase II include age, date of birth, gender, race, ethnicity, education,
income and insurance, marital status, and number of adults and children in household.
Screening history and risk status will be obtained to determine eligibility and serve as
baseline CRC screening data.

Questionnaires will be administered face to face by a Survey Interviewers who will ask
questions and record the answers. Questionnaire administration will be distributed across
three different points: 1) at baseline, 2) post-intervention, and 3) 6 month
post-intervention.

Data collection materials have been developed in English and Spanish and reviewed by a
Cultural Community Advisory Board for cultural fit across our multicultural population of
low-income participants.

Data collection for cost-effectiveness analysis:

Data for the cost analyses will be drawn from study and clinic records and tracked
separately for each phase of the study. Navigators will keep logs of time spent to recruit
sites, run the group classes and implement TN to account for salary spent for Phase I
intervention and control. Phase II navigation calls will be tracked by clinic staff in
contracting clinics. We will also capture the number of clinic appointments made, kept, and
missed without timely cancellation and the number of each of the different types of
screenings received.

Sample Size:

We expect to recruit and randomize 1,840 participants total, allowing 15% attrition (that
is, 85% retention) for a final sample size of 1,600 participants. Approximately 266 groups
of 5-7 participants will be formed, resulting in approximately 133 each in the control
condition and intervention condition. Education groups will begin in staggered sessions over
46 months. Approximately 450 participants will be recruited each year to achieve total
recruitment goals.

Recruitment:

We will recruit older adult, low-income participants in community settings in Phase I by (a)
identifying previously engaged and new formal sites (churches, senior citizen centers,
employers) for recruitment, (b) continuing to canvass nontraditional options (apartment
complexes, neighborhood associations, barber shops/salons, areas of commerce), and (c)
investigating new types of sites to reach a broader range of multicultural populations in
low-income areas.

Members of our Cultural Community Advisory Board (CCAB) include both lay advisors and strong
community leaders and directors representing key institutions with community links.
Eligibility screening will be done in a face-to-face interview and if the criteria are met
the informed consent will be administered.