Increasing Colorectal and Breast Cancer Screening in Women
Phase: NA
Conditions: Breast Cancer Female, Colorectal Cancer
Sponsor: Indiana University

 
 
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Increasing Colorectal and Breast Cancer Screening in Women 
A. Specific Aims 
 
The cancer burden in women could be significantly reduced by increasing participation in 
recommended screening for colorectal cancer (CRC) and breast cancer (BC) in all eligible women. 
Colorectal and breast cancers account for 36% of all cancer mortality among women in the United States.(1, 2) 
Women diagnosed with localized-stage CRC or BC realize at least a 95% five-year survival, whereas those 
diagnosed with distant disease have only a 20% chance of living 5 years.(2) Although regular CRC and BC 
screenings are widely available and a national priority,(2) rates for CRC screening adherence are low and rates 
for yearly screening for BC have recently decreased. Nationally, only 52% of persons report having had CRC 
screening with either fecal occult blood test (FOBT) or endoscopy within the past 5 years.(3) During the same 
time period, mammography rates have shown a disturbing decline; adherence for women ages 50 to 64 has 
declined by 7%, and for women older than 65 years the decrease has been 4.2%.(4)  
A new paradigm of multiple behavior change is emerging that is supported by theoretical and practical 
considerations. Today’s health care providers are challenged to encourage preventive care and early detection 
behaviors at the same time they are treating acute and chronic illnesses. There is limited opportunity for 
counseling on cancer screening during the average clinical visit. Multiple health behavior change research is 
emerging as a new model to change the way in which interventions can be packaged.(5) To date, intervention 
trials have focused on only one behavior even though we know that screening behaviors for BC and CRC are 
related.(6) If we can find an efficacious and cost-effective intervention to increase both BC and CRC cancer 
screening simultaneously, we can not only decrease overall cancer morbidity and mortality in women but do so in 
a more efficient and cost-effective manner. This research will test an intervention to simultaneously increase both 
CRC and BC screening using behavior change strategies and providing access to recommended screening tests 
by enabling appointment scheduling or mailing of FOBT cards through phone contact with a nurse who has 
access to their medical records. 
Routine population-based CRC and BC screening are recommended for women over 50 providing an 
ideal situation to combine screening interventions. First, both screenings are recommended for women 
ages 50 to 75. Secondly, both screenings require an appointment outside of a regular health care visit. Third, 
research demonstrates that the behaviors are correlated (6) and that common variables predict adherence to 
both screenings. Additionally, although cervical cancer screening is also recommended, this screening test is 
conducted during a health care provider visit and requires a thorough history of sexual activity and prior 
screening results. Cervical cancer incidence and mortality rates in the United States are extremely low and the 
American Cancer Society estimates that over half of the 65.6 million Papanicoulau tests done annually are not 
needed.(7) Finally, appropriate testing for cervical cancer is most important in a younger age cohort--not women 
50 and older.(8) Therefore, this proposal will address innovative approaches to increase adherence to 
screening tests for two cancers that have the greatest impact on female cancer mortality in the United States – 
colorectal and breast cancer. 
We are now ready to test a new paradigm that integrates interventions for two screening behaviors 
simultaneously.  Our previous randomized trials demonstrated efficacy for interventions that promote screening 
for CRC and BC separately.(9-11) Using a theoretical paradigm for multiple health behaviors, we will build on 
previous work to develop an individually tailored interactive computer program that promotes CRC and BC 
screening simultaneously. We will test the program using a tailored interactive website (TIWeb). Because 
research has also demonstrated the effectiveness of telephone counseling to promote screening, we will test a 
cancer screening call (CSC) alone and in combination with the TIWeb. The CSC includes counseling tailored to 
the same constructs included in theTIWeb.  In each intervention arm, women will have the opportunity to 
schedule the appropriate screening tests without a prior clinical appointment.  
The proposed interventions will target female patients in a family practice-based research network who 
are 5050 to 75 years of age, nonadherent to current CRC screening recommendations, and may or may 
not be adherent to BC  screening. Nonadherence to CRC screening recommendations is defined as not having 
had one of the recommended screening tests (fecal occult blood test, fecal immunochemical test, sigmoidoscopy, 
or colonoscopy) in the appropriate timeframe.(12) A review of records for 180,000 women in the targeted age 
group and practice plan found that 26% were nonadherent to CRC screening guidelines but were adherent to BC 
guidelines, 44% were nonadherent to both CRC and BC screening guidelines, 10% were adherent to CRC but 

 
 
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not to BC screening guidelines, and 20% were adherent (currently up-to-date) to both screening guidelines. 
Because the group that is adherent to CRC but not BC screening is so small (10%), we will not have power to 
sufficiently test interventions with this group. However, some women who may be at higher risk for CRC because 
of family history will likely be included in the study because family history data is not readily available in the 
medical records.  At baseline interview and during the intervention, these women will be considered at higher 
than average risk for CRC and colonoscopy will be recommended. 
For women who are nonadherent to CRC screening guidelines but adherent to BC screening (Group A), 
the TIWeb and the CSC will encourage CRC screening by building on the women’s success with regular 
BC screening. For women who are nonadherent to both CRC and BC screening (Group B), the TIWeb and the 
CSC interventions will promote both CRC and BC screening simultaneously.  Research indicates that individuals 
who undergo one type of cancer screening are more likely to pursue other forms of screening,(13) making a 
holistic approach to cancer screening efficient and consistent with what would happen in a routine preventive 
care visit. In the proposed study, we also will test the cost-effectiveness of each intervention arm and the 
intervention interactions with demographic and practice variables. Past research(14, 15) has shown that 
interventions vary in both cost and efficacy, making the addition of cost-effectiveness analysis important for future 
translation to practice. We will use a 2X2 factorial design with women randomly assigned to receive one of the 
following: 1) usual care, 2) aTIWeb, 3) a Cancer Screening Call (CSC), or 4) a TIWeb plus a CSC. 
Aim 1: Compare the efficacy (adherence and stage) of four conditions to promote CRC and BC screening 
among women ages 50 to 75: 1) usual care; 2) a mailed TIDVD; 3) a CSC, and 4) a mailed TIDVD + a 
CSC. All women will be non adherent to CRC screening and may or may not be adherent to BC 
screening.  50Group A (nonadherent to CRC screening guidelines but adherent to BC screening 
guidelines) 
 
  
Hypothesis 1 (Primary outcome): There will be differences in CRC screening  adherence and stage of 
adoption, when controlling for adherence to BC screening at baseline, among women who are randomized to 
1) usual care; 2) a TIWeb; 3) a CSC, and 4) a TIWeb plus a CSC.  
 
 
Group B (nonadherent to both CRC and BC screening guidelines) 
Hypothesis 2 (Secondary outcome): In the group that is nonadherent to both CRC and BC screening at 
baseline, there will be differences in adherence to both CRC and BC screening and stage of adoption, among 
women who are randomized to 1) usual care; 2) a TIWeb; 3) a CSC, and 4) a TIWeb plus a CSC. 
 
Aim 2: Compare the cost-effectiveness of four conditions to promote CRC and BC screening among women 
ages 50 to 75: 1) usual care; 2) a TIWeb; 3) a CSC, and 4) a TIWeb + a CSC. Two groups of women 
will be included. Group A includes women who are nonadherent to CRC screening but adherent to BC 
screening and Group B includes women nonadherent to both CRC and BC screening. 
Aim 3: Examine differences in intervention effects by knowledge, cancer screening beliefs, health status, 
demographic variables (age, race, education, and marital status), screening history, out-of-pocket costs 
for screening, baseline stage of adoption, health care site, and participant involvement in the 
intervention. 
 Hypothesis 1: Interactions will be observed when intervention effects are examined by knowledge, 
cancer screening beliefs, health status, demographic variables (age, race, education, and marital 
status,), provider recommendation, screening history, out-of-pocket costs for screening, baseline stage 
of adoption, provider recommendation, and participant involvement in the intervention. 
 
Hypothesis 2: Women receiving care at primary care practices that have on-site colonoscopy available 
will have greater CRC adherence than women receiving care at sites where on-site colonoscopy is not 
available. 
 

 
 
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Our intervention approach will include interactive, tailored, and theoretically based interventions to 
promote appropriate cancer screening based on risk assessment and adherence status. We will use the 
theoretical model proposed by Noar for multiple health behaviors, which identifies common variables that predict 
multiple behaviors.(16) If a woman needs only CRC screening, interventions will deliver messages that affirm her 
prior success with mammography while encouraging participation in CRC screening. For women who are 
currently nonadherent to CRC and BC screening recommendations, the intervention will address both screening 
behaviors, reflective of the clinical encounter women would have with their health care provider. We will also test 
for the effectiveness of the intervention to move women across stages of screening. Exposure to the intervention 
could move a woman from precontemplation (not thinking about having screening) to contemplation (considering 
screening). Past research has demonstrated that stage progression is an important outcome that ultimately leads 
to screening.(17) In today’s health care setting, addressing only one type of cancer screening with patients, if more 
than one is relevant and overdue, would constitute substandard preventive care. Providing a comprehensive and 
interactive preventive health intervention to motivate cancer screening during a single point of contact may be 
the most efficacious and cost-effective approach for increasing cancer screening rates. 
B. Background and Significance 
 
B.1. Prospective randomized trials have demonstrated that routine screening for both BC and CRC 
significantly reduce cancer mortality. Mortality and incidence for CRC and BC are higher than for any other 
cancers among nonsmokers in the United States.(18) In 2009, approximately 24,680 women are expected to die 
from CRC and  40,170 women are expected to die from BC.(12) Timely and routine screening is our best weapon 
against both CRC and BC mortality. Prospective randomized trials have demonstrated the efficacy of screening 
with fecal occult blood tests (FOBT) in reducing CRC mortality by over 30%.(19) The removal of precancerous 
(adenomatous) polyps in the colon and rectum at the time of endoscopic screening has been found to decrease 
CRC incidence by 75% to 90%.(20) Additionally, mammography screening has been demonstrated to decrease 
mortality through early detection in randomized prospective trials conducted over the last 30 years. Eight major 
randomized controlled studies have collectively included more than 500,000 women in screening studies.(21-34) 
Women 50 or over who are routinely screened by mammography demonstrate a 30% reduction in mortality. 
B.2. Screening for both CRC and BC is recommended for women 50 or older. Current guidelines for CRC 
screening recommend starting at age 50 and include 7 different test options for average-risk individuals, 
including: 1) annual FOBT, 2) annual fecal immunochemical test (FIT), 3) stool DNA test (sDNA), 4) flexible 
sigmoidoscopy every 5 years, 6) colonoscopy every 10 years, 6) double contrast barium enema every 5 years, 
or 7) CT colonography (virtual colonoscopy) every 5 years.(1, 35) For persons at increased risk for CRC, 
screening colonoscopy is recommended.(3) Although out-of-pocket cost varies by insurance plan, all insurers of 
women in this study include colonoscopy coverage for those at average or increased risk. 
  
B.3. Research has identified common variables related to a woman’s propensity to be screened for either 
CRC or BC. A description of these variables will be followed by a review of health promotion interventions that have 
been efficacious in promoting CRC and BC screening. Additionally, we will review the theoretical support for tailored 
interventions, including our preliminary studies that demonstrated efficacy in increasing CRC and BC screening. 
Tailored interventions are defined as “any combination of information and behavior change strategies that are 
designed to reach one specific person, based on characteristics that are unique to that person.” Information is also 
tailored to the outcome of interest - in this case CRC and BC screening.(36) Research supports tailored and 
interactive CRC and BC screening interventions as a promising strategy for influencing attitudes and behaviors. 
Research also supports proactive outreach by the health care setting in the form of Cancer Screening Calls (CSC), 
which have yielded significant increases in mammography adherence.(11) Goldstein (2004) has specifically 
addressed an evidence-based strategy for increasing behaviors that includes arranging or scheduling appointments 
or providing increased access to care.(37) Finally, an important component of screening interventions is the cost of 
delivery. We will provide support for adding the cost-effectiveness component as well as rationale for comparing the 
various intervention strategies. 
B.4. Common predictors including risk, benefits, barriers, and self efficacy have been identified for both 
BC and CRC screening. Beeker(38) conducted 14 focus groups to identify knowledge, attitudes, and beliefs 
about CRC screening. Respondents had little knowledge about their own risk or the benefits of screening. 
Barriers such as embarrassment, inconvenience, physical discomfort, and concern about being able to actually 

 
 
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complete screening tests were cited. Knowledge about cancer and knowing someone with CRC have been 
related to adherence to both FOBT(39-41) and flexible sigmoidoscopy.(39, 42) Manne(43) studied the relationships of 
the Transtheoretical Model (TTM) and Health Belief Model (HBM) variables to stage of screening and adherence 
for CRC, finding that perceived risk, benefits, and barriers, among other variables, were related to both stage of 
screening and adherence. In prospective studies of patient or community populations, the demographic 
characteristics of being older (over 70 years of age), being male, having less education, and being of low income 
were consistently negatively associated with FOBT. Adherence was lowest in persons aged 70 or older. 
However, a gender bias favoring male utilization of endoscopy was suggested when authors found that men are 
more likely to be screened than women.(44, 45)  Studies have shown the predictive value of higher perceived risk 
and perceived benefits, and lower perceived barriers for CRC screening for both average-risk individuals and 
those at increased risk due to family history.(43, 46, 47) 
Descriptive research has identified beliefs such as perceived risk, benefits, and barriers to BC screening, as well 
as self-efficacy as important in predicting mammography adherence. Younger age and higher education are also 
reported to predict increased adherence.(48-50)  The barrier “fear of cancer” has emerged as a salient factor to be 
considered when evaluating the predictors of BC screening.(50, 52) The same beliefs - perceived risk, benefits, 
barriers, and self-efficacy - are related to stage of screening for BC. Skinner(53) and Lauver(54) both found beliefs 
were significantly different among women in precontemplation (no intent to screen), contemplation (intent to 
screen) or action. In both studies, higher perceptions of benefits and fewer perceived barriers predicted a more 
advanced stage of mammography adoption. Finally, recommendation by a health care provider has been 
consistently linked to screening.(55),(56-63) 
B.5. Research has supported the efficacy of tailored interventions for increasing CRC and BC 
screening.(64-66) Tailored interventions can be delivered in several ways. King et al.,(67) Marcus et al.,(68) and 
Rimer et al.,(69) along with the proposed investigators,(70) have delivered tailored mammography counseling 
interventions by telephone and found significant increases in mammography use. A recent innovation is using 
computer-tailored print materials created specifically for individual recipients based on their responses to 
particular questions.(71-73) Randomized controlled intervention trials comparing tailored and non-tailored print 
communications have demonstrated that tailoring enhances intervention efficacy in promoting mammography 
use.(74, 75) For example, Skinner and colleagues(75) found that among low-income women nonadherent at 
baseline but considering a mammogram, those who received tailored print communications were much more 
likely to have a mammogram than those whose print communications were not tailored (75% vs. 32%). Lipkus 
et al,(64) and Rakowski et al,(65) also found an advantage in tailoring mammography interventions. Clark et al,(76) 
demonstrated the advantage of stage-matched tailoring as compared to non-stage-matched tailoring.  
Interventions that have been tailored to individuals’ beliefs about CRC screening have also been efficacious in 
increasing CRC behavior. Jerant (77) found that a tailored interactive computer program significantly increased 
beliefs and stage of readiness for CRC screening. Studies that have addressed variables theoretically related 
to CRC screening behavior such as knowledge, health beliefs, and attitudes have yielded high rates of 
participation in FOBT and sigmoidoscopy.(78-82)  
B.6. Technology has opened a new paradigm for tailoring health messages to individuals. Interactive 
computer programs, whether delivered via TIWeb or some other platform, allow linkage of participant 
responses to individualized messages that are then delivered to the user in real time.(83) There is evidence that, 
regardless of age, education, or socioeconomic status, people like these interactive programs.(84-91) 
Advantages of interactive programs include not requiring the presence of an educator or nurse counselor, 
private and consistent information delivery, and the ability to meet the needs of people with low literacy.  
TIWeb allow users to interact with the program using a mouse or keys on the keyboard, which would likely be 
familiar to those with computers or experience with computers. The number of households with broadband 
internet  is now 67%. 
B.7. Intervention messages can be tailored in real time through a proactive counseling call from a 
health care provider and have been used with both CRC and BC screening.(56-63, 94, 95) Stone found that use 
of a designated staff member to focus on patient reminders increased CRC screening by an odds ratio of 2.75.(95) 
Many studies have tested the effect of telephone interventions among both healthy community-residing adults 
and cancer survivors and found telephone counseling to be as effective as face-to-face encounters.(96) Taplin 

 
 
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found that a brief reminder call from a health care staff member that included an opportunity to schedule a 
mammogram significantly increased mammography adherence over a simple reminder postcard.(11)  
B.8. Cost-effectiveness analysis of screening interventions is necessary to guide decision-makers 
toward the most efficient means to achieve important health behaviors and outcomes and the costs of 
providing the interventions. Population screening for CRC has been shown to compare favorably to other 
expenditures in the health care field.(97-99) Another important issue is the cost-effectiveness of interventions to 
increase CRC screening. Cost-effectiveness analysis for intervention delivery is defined as the cost per 
individual screened.(100) Abrams (1999) identifies cost per incremental gain in outcome as one of the key 
factors in translating research. Unfortunately, almost a decade later, we still lack data on the cost-effectiveness 
of tailored interventions as compared to other more commonly used practice interventions.(101)  
An important component of this proposal is the estimation of the efficacy and cost-effectiveness of interactive 
interventions tailored to beliefs and stage of adoption alone and together. Similar to other studies, the outcome 
to be compared in the cost-effectiveness analysis is the proportion of participants in each of the intervention 
arms who have had recommended CRC or BC screening tests during the six-month period following initial 
intervention. Using this design, we will be able to determine if aTIWeb, a CSC, or a TIWeb+ CSC will significantly 
increase adherence for CRC and/or BC screening and at what costs. If efficacy and cost effectiveness relative to 
other interventions are demonstrated with the TIWebprogram, it could be promoted at health care visits. If the 
CSC increases screening at an acceptable incremental cost when added to the TIWeb, office staff could make 
telephone counseling calls to participants from the health care setting after the TIWeb. 
B.9. Researchers have tested the effectiveness of intervening simultaneously for multiple health 
behaviors. In 2005, Emmons et al. reported that a telephone-delivered intervention which focused on six 
behavioral risk variables for colorectal cancer was effective in promoting change.(102) In a different research 
study, a home-based intervention to change smoking, high fat diet, and sun exposure produced significant 
changes as compared to a control.(103) Recently, a series of articles addressed multiple behavior research.(5) 
Behaviors included weight management, smoking, exercise, and fruit and vegetable intake.(104-106)  All 
interventions that addressed multiple behavior change were effective.  
Theoretical considerations for multiple behavior change have been presented by Noar et al. (2007).(66) A key 
theoretical consideration is to identify common principles or variables that have been found to predict 
behaviors. An example includes the variables of benefits and barriers (pros and cons) that are common to 
many theories. Health behavior theories have driven many interventions to change single behaviors.(16) Most 
theories, however, include a common set of variables that determine behaviors as is the case with BC and 
CRC screening. If similar variables do predict multiple behaviors, interventions that address several behaviors 
can be effectively combined. Additionally, research has demonstrated the superiority of simultaneous 
interventions over sequential interventions when addressing multiple behavior change.(107)  
The use of a multiple behavior theoretical approach is especially appealing when addressing behaviors 
that are conceptually similar-such as cancer screening behaviors. For women, guidelines support 
population screening for both BC and CRC. Screening for BC and CRC have many commonalities and the 
behaviors have been found to be correlated.(6) Additionally, common variables are known to predict both 
screenings. These variables include perceived risk, benefits and barriers to screening, as well as self-efficacy. 
Risk for both cancers is driven by age and family history, and routine screening is supported for both starting at 
50 years of age. Both screening behaviors include benefits of finding cancer early, thus decreasing the need 
for aggressive treatment and saving the individual’s life. Barriers, or cons to each behavior, are strongly related 
to action but vary depending on the screening behavior.  
The common variables that will be used to deliver simultaneous messages originate in the Health Belief Model 
(HBM) and the Transtheoretical Model of Behavior Change (TTM)-both of which have demonstrated efficacy with 
single behaviors. The multiple behavior theoretical approach will build on this previous work by identifying the 
common variables that have predicted behavior change and applying these tailoring of these variables 
simultaneously to CRC and BC screening. The variables have been integrated into a conceptual framework that 
will guide the proposed study (see Figure 1) and  include: perceived risk, perceived benefits and barriers to a 
health behavior and self-efficacy to accomplish the behavior.(108, 109), (110) The belief variables of perceived risk, 
perceived benefits and barriers, and perceived self-efficacy have been used in previous interventions and found 

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Beliefs about CRC & BC 
screening (Risk, Benefits, 
Barriers, Self-Efficacy)
Intervention
TIDVD 
+ CSC
CSC
TIDVD
Usual 
Care
Patient 
Involvement
Antecedents
Mediators
Outcomes
Stage of Screening for
CRC or BC screening
Knowledge about CRC & BC
Demographic/ 
Experiential Variables
Demographics (age, 
race, education, marital 
status)
Past CRC & BC screening     
Health status 
Comorbidities
Media Exposure
Knowledge/Beliefs 
Variables
 Knowledge
 Perceived Risk
 Benefits
 Barriers
 Self Efficacy
Health Care Services
 Presence of 
Colonoscopy service at 
site
Breast Cancer & 
Colon Cancer 
Screening 
and Stage
Cost-
Effectiveness

 
 
Version date 1.24.2014   IRB Protocol #1009001808 
 
C. Preliminary Studies 
 
Dr. Champion has a strong history of developing and demonstrating the efficacy of tailored mammography 
interventions and of collaborating with Drs. Rawl, Springston, Zollinger, and Monahan.  Dr. Rawl, the study Co-I, 
conducted several CRC studies and collaborated with Dr. Champion on both BC and CRC screening studies. 
Preliminary data presented below support tailored interventions significantly improving adherence to both BC and 
CRC. 
 
The efficacy of a computer-tailored printed physician recommendation letter plus information packets 
versus tailored telephone counseling for mammography adherence was tested with women accrued 
from two managed care sites (R01NR04081, 1996-2000).(70) At two months post-intervention, percentages of 
participants in the action stage (i.e., recently screened) differed across groups; 1) usual care- 26%, 2) tailored 
letter- 38%, 3) tailored telephone- 36%, and 4) tailored letter plus telephone counseling-40%. Compared to 
usual care, all intervention groups significantly increased mammography adherence (odds ratios 1.60 to 1.91). 
We also considered stage movement by intervention. That is, baseline precontemplators could move one 
stage to contemplation or two stages to action post-intervention. Contemplators could move forward one stage 
and become adherent, or women could remain in their current baseline stage. Analyses controlling for 
covariates showed that all intervention groups moved women forward in stage. For contemplators, the 
combination of telephone and print was clearly the most effective intervention for promoting both 2-month 
stage movement (OR = 2.5, p < .0005) and 4-month adherence (OR = 2.1, p = .0003). It appeared that adding 
printed material to the phone messaging had an additive effect and that it may be a useful intervention to move 
women forward in stage even if adherence is not the outcome. 
The investigators developed and tested a tailored interactive computer program for low-income African 
American women who were clients of a multi-service community center in Indianapolis (R01CA77736, 
1999-2005). The program content addressed perceived breast cancer risk and perceived mammography 
benefits, barriers, and self-efficacy. Using a randomized trial design, we compared women receiving: 1) a tailored 
interactive computer program, 2) a targeted, culturally appropriate videotape promoting mammography 
specifically for African American women, and 3) usual care. The results showed that the odds of adherence 
were twice as great (OR = 2.0) for the interactive computer program compared to the targeted video.(123) The 
interactive computer program was significantly better than either pamphlet or video in moving a woman forward 
in mammography adoption stage. 
We are currently testing the efficacy of a tailored DVD mailed to a woman’s home against an interactive 
tailored phone intervention for women aged 50 to 75 who are nonadherent to BC screening. Preliminary 
data from the study indicated that there was a significant difference (p<0.05) in mammography adherence at 1 
month between women receiving a DVD (18%) or a phone counseling session (20%) as compared to usual care 
(10%). At six months, the adherence levels were 61% for the DVD group, 56% for the phone counseling group, 
and 45% for the usual care group. Additionally, we found that 83% of women who received a mailed DVD 
completed the interactive DVD and reported it to be highly usable (Mean of 4.79 on a 5 point scale). Although 
data are preliminary, it can be concluded that women used the DVD when mailed to their homes and that both 
the mailed DVD and phone counseling session were significantly more effective than usual care.  
 
Finally, Drs. Rawl, Champion, and Springston are testing a tailored interactive computer program 
designed to promote CRC screening among African Americans in a primary care setting through a 
current intervention trial funded by the National Cancer Institute (1R01 CA115983, 2006-2011). Prior to 
this trial, Drs. Rawl, Champion, and Skinner, with support from the Walther Cancer Institute, collaborated on 
the development of an interactive computer intervention designed to increase CRC screening among African 
Americans. Variables that are being assessed and used to generate tailored messages include health beliefs 
such as perceived risk of CRC, perceived benefits and perceived barriers to screening, self-efficacy, and stage 
of adoption. Preliminary results from this ongoing pilot study showed that, among persons who were 
noncompliant with FOBT at baseline, participation increased to 43% in the interactive computer group 
compared to no change in the control group. Satisfaction with the program was very high; of 36 African 
Americans who evaluated the program, 100% indicated they found the program interesting, easy to use, easy 
to understand, and that it provided important information.  
 

 
 
Version date 1.24.2014   IRB Protocol #1009001808 
 
This proposal builds on over a decade of intervention research by study investigators, who have found 
that interactive tailored interventions and telephone counseling increase both CRC and BC screening 
behaviors. Our current work has demonstrated that both a mailed DVD and a counseling call are more effective 
than usual care, but we have yet to compare the interventions against each other or considered the additive 
effect of these two interventions compared to each other or usual care. Because we are also assessing important 
covariates such as stage of screening, race, age, and out-of-pocket costs, we will be able to determine which 
intervention is more effective for subgroups of women. This proposal is unique in that it compares the efficacy of 
interventions that include either CRC screening alone or both CRC and BC screening combined based on the 
individual needs of the participant. Screening research, however, has not tested promotion of more than one 
behavior at a time nor has research compared an interactiveTIWeb, a CSC, or the combination against each 
other or usual care.(6) 
The proposed research is innovative in two important ways. First the interventions being tested will provide 
the opportunity for participants to receive or schedule screening tests by phone. We are including an access-
enhancing component in both interventions to simplify the screening process.  Women in all groups can request 
a mailed FOBT card or can schedule appointments for colonoscopy and mammograms, as needed,  on the 
phone.(14, 15)  Second, we will examine both the efficacy and the cost-effectiveness of these interventions. 
Lairson(124) has emphasized the importance of defining the costs attributable to both intervention development 
and personnel costs. This information will be key to translating the intervention to practice if found to be 
efficacious.  
Rationale for Combining BC and CRC Screening. There are several arguments for simultaneously promoting 
BC and CRC screening.  It makes little sense and could be argued that it is negligent to promote CRC screening 
without recommending BC screening if both are needed. The focus on comprehensive screening for cancer is 
emerging as the model for health care. In a supplement to the American Journal of Preventive Medicine, a series 
of health care policy experts provided a comprehensive overview of the need to address multiple behavioral risk 
factors in primary care, yet research on implementing interventions that promote multiple screening behaviors is 
limited.(125)  
Three arguments support this trial which combines BC and CRC screening into one intervention. First, in a 
supplement to the American Journal of Preventive Medicine, health care policy experts provided a 
comprehensive overview of the need to address multiple behavioral risk factors in primary care especially in 
relation to cancer screening.(126)  Prochaska argues that the burden of health care and the importance of 
preventive medicine demand that interventions be more efficient and cost-effective.(5)  A more integrated 
approach to preventive care can lead to better outcomes with less provider burden and lower costs for our health 
care system.   
Secondly, research has demonstrated that similar variables drive adherence to both BC and CRC screening.  
The principal investigators have found that tailored interventions targeting perceived risk, benefits (pros), cons 
(barriers), and self-efficacy have been effective in increasing both BC and CRC screening behaviors. In a meta-
analysis Hall and Rossi, (2008) described 48 target behaviors, including mammography and colonoscopy, that 
were driven by the theoretical concepts of pros and cons.(43, 127, 128) Thus similar variables drive both behaviors. 
Research also has demonstrated a strong relationship between participation in mammography and CRC 
screening.(129)   
Third, it is possible that co-variation does occur and would be demonstrated if the uptake of one screening 
behavior increases the odds of uptake for another. Noar (2007) discussed a multiple behavior approach that 
would identify behaviors that might be expected to change together. Combining an intervention to increase 
screening for both BC and CRC has the potential to be synergistic as well as additive. 
D. Research Design and Methods 
D.1. Research Design. We propose a prospective randomized 2X2 factorial design: 1) usual care; 2) aTIWeb; 
3) a Cancer Screening Call (CSC), and 4) a TIWeb + a Cancer Screening Call (CSC). The intervention will be 
tested in two groups of women. Group A will include women who are nonadherent to CRC but adherent to BC 
screening guidelines. Group B will include women who are nonadherent to both CRC and BC screening 
guidelines. Random assignment to intervention 

 
 
Version date 1.24.2014   IRB Protocol #1009001808 
 
arms will be performed within both Group A and Group B. A periodic list of eligible women will be pulled from 
databases and sent to the research study office at IUSON.  The list will then be forwarded to the co-investigator 
in charge of recruitment  (Dr. Deborah Allen, Executive Director for the Indiana Family Practice Research 
Network) and the physicians for the opportunity to review their own patient list.  This information will consist of 
name, DOB/age, address, and phone number.  An additional field will include mammogram status, indicating 
whether the individual has a documented mammogram in the past 15 months. Then a letter, brochure, and 
refusal postcard will be sent to potentially eligible women. A parsed list of women who don’t opt out by returning 
the refusal post card, calling a toll free number, or emailing the project manager (number and email provided on 
brochure) will be scheduled for a recruitment phone call. Participants in the TIWeb Intervention Arm will be 
given access to a TIWeb that is programmed to provide an intervention that is interactive and tailored to the 
participant’s individual beliefs and demographics. Individuals receiving the TIWeb will be given information that 
allows them to call and receive an FOBT kit in the mail or schedule an appropriate CRC test and/or 
mammogram. The physicians at the recruitment sites will have reviewed the list of potential participants before 
recruitment to ensure they are candidates for screening tests. 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Women randomized to CSC will receive a telephone counseling call during which the opportunity to complete 
CRC screening (FOBT or a colonoscopy) and/or mammography will be offered. The CSC will include tailored 
counseling as well as the ability to schedule BC and CRC screening tests. The combined TIWeb + CSC group 
will receive a mailed TIWeb followed in four weeks by a CSC with the same opportunity to receive FOBT kits or 
schedule a colonoscopy and/or mammogram. The nurse counselor, knowing the participant is a good 
candidate for screening tests, will be trained to schedule CRC or BC screening appointments or to mail FOBT 
kits to individuals in the intervention groups even if they have not had a recent clinic visit. The usual care group 
will receive usual care that varies dependent upon the practice setting. Participants will have a baseline 
telephone or electronic survey prior to randomization that assesses beliefs, knowledge, self-reported CRC & 
BC screening, and other study variables. Four weeks following intervention, participants will be surveyed via 
Figure 2. Study Schema 
Group A (had mammo) 
Group B (no mammo) 
(Control for mammo) 
Randomize 
6-month telephone survey & 
Claims + Medical record audit 
4-week telephone survey 
assessing intervention use 
TIWeb 
TIWeb 
Usual 
Care 
Eligible women mailed invitation letter with opt-out postcard 
List of women who do not opt out in two weeks  
Women contacted by phone, screened for eligibility and verbal consent obtained. Informed consent 
mailed. Baseline interview completed during telephone contact or scheduled within 1 week of 
consent 
CSC 
Eligible women identified through administrative databases 
Figure 2. Study Schema 

 
 
Version date 1.24.2014   IRB Protocol #1009001808 
 
telephone or electronic survey on CRC & BC beliefs, knowledge, and participant involvement in and 
satisfaction with the intervention. Again at 6 months, a final telephone or electronic survey will be done and 
claims data collected. (See Figure 2) A Community Advisory Board will be involved in design and review of 
interventions, accrual, and intervention delivery. 
 
In order to tell whether or not the two week opt out period is sufficient time for women to opt out, the PI and 
project manager will monitor a spreadsheet that will be developed for tracking calls made by study staff to 
women who indicate that they did opt out of the study by returning the refusal postcard, calling the toll free 
number, or emailing the project manager.  If a woman indicates that she did opt out the study staff will 
apologize and indicate to the project manager or PI that this has happened.  The project manager will then 
make sure her documentation is destroyed.  Once this occurrence has happened a total of ten times, the PI will 
reevaluate the opt out time period and consider revising.  Any occurrences will be reported to the IRB at 
continuing review. 
 
 
D.2. Eligibility Criteria. Women will be considered eligible if they: 1) have been a patientof any of the 
participating physicians 2) ages 50 to 75; and 3) nonadherent to CRC screening guidelines and 4) have high 
speed Internet access. Exclusion criteria are: 1) having a personal history of colorectal cancer, colorectal polyps, 
or inflammatory bowel disease, and 2) having any medical conditions that would prohibit a mammogram or CRC 
screening. We are excluding women at high risk due to the exclusion criteria above which can be obtained 
through medical records. However, there will be women at higher than average risk for CRC due to family history 
that will likely be entered into the study.  We will obtain the information about family history during the baseline 
interview and it will be considered through the intervention. Women at higher than average risk because of family 
history will be encouraged to have a colonoscopy. 
Nonadherence to CRC screening guidelines will be defined as having had neither: 1) a fecal occult blood test in the 
last 12 months; or 2) a fecal immunochemical test in the past 12 months; or 3) a sigmoidoscopy more than 5 years 
ago; or 4) a colonoscopy more than 10 years ago.  The algorithm for training research assistants to determine 
eligibility/adherence at baseline for CRC is included in Appendix A.  
Women may or 
may not have 
had a 
mammogram in 
the last 15 
months. 
Women who 
are 
nonadherent to 
CRC guidelines 
but current with 
mammography 
will be in Group 
A. Women who 
are 
nonadherent to 
CRC screening 
guidelines and 
have not had a 
mammogram in 
the past 15 
months will be in Group B. Although there is a small group of women who could be adherent to CRC screening 
but not to BC screening (10%), the numbers are too small to have adequate power for testing hypotheses. In 
practice, however, the program can be easily modified to also accommodate women who are adherent to CRC 
but not to BC screening. Because administrative data may not include complete screening history information, 
adherence to CRC and BC screening guidelines will be verbally verified with each woman prior to consent to 
Table 1. Timeline  
 
Activity 
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
Q1  Q2  Q3  Q4 
Q1  Q2  Q3  
Q4 
Q1  Q2  Q3  
Q4 
Q1  Q2  Q3  Q4 
Q1  Q2  Q3  Q4 
Intervention Development 
  X    X     X    X 
 
 
 
 
Refinement of process 
and outcome measures 
 
       X   X 
 
 
 
 
Development/testing of 
study databases 
                  X    X  
 
 
 
 
Training research staff 
           X    X   X 
 
 
 
 
Intervention pre-testing 
          X    X 
 
 
 
 
Participant Enrollment 
         
X        X     X  X 
X     X    X    X 
X      X    X    X 
 
Baseline data collection & 
intervention delivery 
 
 
 
X       X    X    X 
 
X     X    X   X 
 
X     X    X     X 
 
4-week follow-up 
interview 
 
 X     X    X     X 
 X     X    X   X 
X    X     X     X 
 
6-month follow-up 
interviewed med record 
audit 
 
                X     
X      
X      X    X   X 
X    X     X     X 
X      X 
Data cleaning and 
analyses 
 
 
 
X     X     X    X 
X    X    X    X 
Analysis, write-up, 
dissemination 
 
 
 
 
X    X    X   X 
Quality Assurance 
 
X     X    X    X 
X     X     X   X 
X     X           X 
X 

 
 
Version date 1.24.2014   IRB Protocol #1009001808 
 
determine eligibility. This will allow us to screen out women who are ineligible because they have received CRC 
or BC screening within the appropriate timeframe. The study timeline is illustrated in Table 1.  
A minimum age of 50 was selected to allow women time for screening after they turned 50. If a woman 
develops CRC or BC during the study, she will no longer be a candidate for routine screening and her data will 
be deleted from final analysis. In our past work, this occurred only 2-4 times over the course of any given 
project. Claims data will verify initial eligibility regarding age and CRC and/or BC screening status followed by 
verbal confirmation at time of enrollment. 
D.3. Sample. In the Power Analyses section, we show that inclusion of 397 participants in each of the four 
intervention groups - usual care, TIWeb, CSC, and TIWeb plus CSC - will yield adequate power to detect 
clinically significant effects at 6 months. The sample size also takes into account the average rollover of 
women to different health care plans that may occur during the course of this study. Women members are 
approximately 81% Caucasian and 19% African American. Letters of support for all sites are included in the 
consortium agreement section.  
We will use a total of eight practice sites of which four have colonoscopy available on site and four that must 
schedule colonoscopy at other locations. The first four sites with colonoscopy facilities have approximately 8,500 
women patients who are between the ages of 50 and 75. The second four sites without colonoscopy have 8,700 
potentially eligible women patients for a total of 17,200 women. According to our prior data approximately 26% 
are nonadherent to CRC but adherent to BC (n=4472) and 44% are nonadherent to both (n=7568). Our study 
requires 1588 women for Group A (nonadherent to CRC) and Group B (nonadherent to both CRC and BC 
screening) total (see Section D.1.2). Assuming a 50% acceptance rate, we will contact 3176 total for both 
groups. Although there will be some participants who cannot be contacted because of recent moves or change in 
telephone numbers, our past work (Preliminary Studies) has shown that fewer than 13% would be lost to follow-
up or because of change in insurance. In a current ongoing study, we have found that up to 30% of phone 
numbers are incorrect, reflecting increased use of cell phones. Assuming the worst case scenario of 30% 
incorrect numbers, we will have more than adequate numbers to enroll the total of 1588 women. 
D.4. Recruitment/Accrual Procedures. Recruitment and other study procedures are depicted in Figure 2. 
Our recruitment procedures have been determined to be Health Insurance Portability and Accountability Act 
(HIPAA) compliant. A periodic list of eligible women will be derived from the Indiana Network for Patient Care (INPC), 
Community Health Network, or may be provided by the participating physicians or their designee and sent to the research study office 
at IUSON.  The list will then be forwarded to the co-investigator in charge of recruitment (Dr. Deborah Allen, 
Executive Director for the Indiana Family Practice Research Network), and the participating physician will have 
the opportunity to review. The lists will include contact information (name, address, DOB/age, and phone 
number) as well as mammogram status (y/n) indicating whether the subject has a record of mammogram in the 
past 15 months.  Each potentially eligible woman will be mailed an informational letter about the study 
(Appendix B) and brochure. A postage-paid postcard will be included for women to return should they not 
wish to be contacted. Women may opt out by mailing back the refusal postcard, calling a toll free number, or 
emailing the project manager (number and email provided on the letter and the brochure). In order to tell 
whether or not the two week opt out period is sufficient time for women to opt out, the PI and project manager 
will monitor a spreadsheet that will be developed for tracking calls made by study staff to women who indicate 
that they did opt out of the study by returning the refusal postcard, calling the toll free number, or emailing the 
project manager.  If a woman indicates that she did opt out the study staff will apologize and indicate to the 
project manager or PI that this has happened.  The project manager will then make sure her documentation is 
destroyed.  Once this occurrence has happened a total of ten times, the PI will reevaluate the opt out time 
period and consider revising.  Any occurrences will be reported to the IRB at continuing review.  Once the two-
week opt-out period has passed, research assistants (RAs) at the Center for Survey Research will call each 
woman using a “call sheet” with the woman’s name, address, and telephone number and with spaces for 
recording information about each call attempt, including the date, time, disposition (e.g., busy, no answer, 
answering machine), and callback preference. If the woman is not reached initially, RAs will make up to 10 call 
attempts at different times. Ten calls allows the staff to have adequate attempts to reach the woman.  The calls 
will be made at different times of day and different days of the week.  After reaching an eligible woman, the RA 
will verify eligibility and explain the study.( See Appendix A). Eligibility based on nonadherence to CRC 
screening guidelines will be determined first as defined in section D.2. Women then will be asked about their 
last mammogram. Women who have had a mammogram in the past 15 months will be in Group A and those 

 
 
Version date 1.24.2014   IRB Protocol #1009001808 
 
who have not in Group B. The RA will also review the entire study verbally with the potential participant. 
Women will be referred to the introductory letter that indicates what study involvement includes. If a woman 
agrees to participate, the RA will obtain verbal consent for the study and conduct a baseline telephone 
interview immediately or schedule a more convenient time within one week. If she would like to complete the 
baseline interview electronically, she will be given instructions on how to do that. HIPAA documentation for 
release of medical records will be accessed and signed electronically at the time of the second online 
questionnaire.  The woman will be able to review the electronic forms before indicating her signature. She will 
be able to print off the form as well. If a woman declines participation, she will be thanked for her time. We will 
need a cohort of approximately 45 women consented each month for 36 months to accrue a total of 1588 
women. Assuming 50% will agree to participate, we will actually contact approximately 90 women each month. 
Summary: 
1) . A list of eligible women will be pulled from databases and sent to the research study office at IUSON.  The 
list will then be forwarded to the co-investigator in charge of recruitment (Dr. Deborah Allen, Executive 
Director for the Indiana Family Practice Research Network), and the physician at each recruitment site will 
have the opportunity to review the list  Data will include name, address, DOB/age, and phone number as 
well as mammogram status.  Each woman mailed an informational letter about the study and brochure. If 
the woman has not declined in two weeks, the woman’s name will be added to the recruitment call list. 
2) Trained RAs at the Center for Survey Research will begin call attempts to those women who had not opted 
out of the study. 
a. The RA will attempt 10 calls 
b. The call attempts will be logged on a call sheet. 
If the woman is reached, the RA will verify eligibility using the screening questionnaire.  
3) The RA will also review the entire study by reading the study information sheet over the phone, ask if she is 
interested in participating, and conduct a baseline interview at that time (or within 1 week if it’s not a 
convenient time) if she agrees to participate in the study and gives verbal consent for the study. 
a. If she does not want to participate, she will be thanked for her time and her information will be 
destroyed. 
4) After a woman provides verbal consent over the phone, she will be prompted to do the electronic HIPAA 
form at the time of the second online survey. 
5) Once the consent and authorization are given, the woman is eligible for the rest of the study. 
a. A reminder call will be made if the first online survey is not completed within 2 weeks.  A refusal 
postcard will be sent if she cannot be reached. 
6) Depending on the randomization of group: 
a. Those receiving TIWeb only, the TIWeb information will be mailed and emailed out within 1 week of 
receiving the consent and authorization. 
b. Those receiving the cancer screening call, the RA will begin attempting 1 week after receiving the 
consent and authorization 
c. Those receiving the TIWeb and call, the TIWeb information will be mailed and emailed within 1 
week of receiving the consent and authorization.  The call will then be attempted 1 week after the 
mailing of the TIWeb information. 
7) Data collection calls or electronic communications will be placed at 4 weeks and 6 months following the 
intervention by the Center for Survey Research in Bloomington. 
8) Information will be stored in locked file cabinets in a locked research office and data stored on a database 
that is password protected.  This database will be used for this study only. 
 
D.5. Data Collection. The baseline interview by phone or electronic communication, which will occur during 
the verbal consent call or within 1 week if the women needs a more convenient time, will include questions 
about CRC and BC screening as well as questions for perceived risk, benefits, barriers, and self-efficacy. 
Sociocultural/demographic variables will be measured for subgroup comparisons. The computer program used 
to conduct telephone surveys will have the randomization scheme integrated into the program. When a 
baseline survey is completed, the computer program will provide the randomized group assignment to the 
research assistant. The research assistant will then provide instructions to the participant based on her 
randomized group assignment. 

 
 
Version date 1.24.2014   IRB Protocol #1009001808 
 
Those randomized to the TIWeb or CSC intervention group will be told they will receive a TIWeb or CSC in the 
next week followed by data collection calls at four weeks and six months. Women randomized to the TIWeb plus 
CSC will be told they will receive access to TIWeb in the next week followed by the CSC about CRC or BC 
screening as well as data collection calls or electronic communication at 4 weeks and six months. The usual care 
group will be told they will receive telephone calls or electronic communication for data collection at 4 weeks and 
six months. At the 4-week interview, women will be queried about their receipt, recall, and use of the TIWeb and 
their recall of the CSC. At six months, women will be asked about their screening behaviors. Participants will be 
offered a $20 gift certificate for each telephone survey they complete, for a total of $60 per participant across the 
entire study. This small incentive compensates women for their time. Table 1 contains a timeline of project 
activities.  
D.6. Tailored Interactive Website (TIWeb). The interactive program will operate from a computer. The specific 
graphic design will be determined 
after Community Advisory Board 
(CAB) preference testing, but be 
similar to the sample screens 
provided in Appendix C. Control 
buttons will be large enough to be 
easily seen and will be clearly 
labeled for easy identification. The 
narrator will walk the viewer through 
every aspect of the program so that 
each woman can easily respond to 
data queries. The program will also 
be designed to allow a woman to 
stop the program at any given point 
and return later to that place in the 
program. 
D.6.1. ITWeb Development: 
Message libraries, tailoring 
algorithms, and the majority of the 
content that will be included in the 
proposed 
TIWeb and 
CSC have 
been 
developed in our preliminary studies. The development of TIWeb programs will begin by convening all key 
stakeholders: (1) content experts, Drs. Champion and Rawl; (2) Dr. Kathy Russell, head of the Community 
Advisory Board; and (3) the design team from the University of Georgia led by Dr. Jeff Springston. First, we will 
conduct scientific review and content inventory of Dr. Champion and Rawl’s existing interactive programs and 
identify the components that will be used for each TIWeb program. Next, we will engage the Community 
Advisory Board by eliciting feedback on the user interface and navigation of the existing programs in 
meetings facilitated by Dr. Russell. The primary outcome of the meetings with the Community Advisory 
Board will be to clearly identify the goal of the TIWeb programs from the users’ and stakeholders’ 
perspectives. We will also elicit information from our community advisors about user characteristics and 
preferences for the “look and feel” of programs, including users’ expectations of how the interactive products 
should work in the home setting, that is, contextual factors. 
Based on the results of the CAB session and scientific review, co-investigators Rawl and Champion will 
develop a content matrix document, incorporating theoretical constructs. The document will identify theoretical 
constructs, user input, core content, health messages, and media assets (e.g., video clips, audio files, 
animations) in a hierarchical classification that will determine the information flow. Although the matrix 
document will continue to be refined in subsequent iterative design phases, the design team will use the matrix 
to identify the number and type of media assets to be created as well as the basis for algorithms that will 
determine navigation pathways. 
Table 2. Messages for Screening by Stage 
Group A   Introduction / Instructions about TIWeb 
Questions to determine age, objective risk for 
BC & CRC, and BC & CRC screening stage
Generic Information
User Input
Tailored messages
Build on Knowledge 
of BC to deliver CRC 
Knowledge 
Build on Benefits of 
mammography to 
increase Benefits of 
colonoscopy CRC
Self-Efficacy
Message for 
colonoscopy 
tailored to person
Barriers
Messages for CRC 
tailored to individual
Concluding Remarks
Build on risk of 
BC to clarify risk 
of CRC
Self efficacy for 
FOBT 
or colonoscopy
Barriers assessed for FOBT 
or colonoscopy
Benefits of
FOBT 
or colonoscopy
Knowledge of 
CRC
Perceived risk
CRC
Average Risk CRC
Choice of CRC Screening
Assessment and message 
For stage
Increased Risk  due
to Family History
Colonoscopy (CP)
Assessment and message
For stage
Self-Efficacy
Message for  
CRC tailored to 
person
Barriers
Messages for  
CRC tailored to 
individual
Self efficacy for 
mammography &  
colonoscopy
Barriers assessed 
for mammography & 
colonoscopy
Benefits of 
colonoscopy
Knowledge of 
CRC
Perceived risk
CRC
Build on risk of 
BC to clarify risk 
of CRC
Build on Knowledge of BC to 
deliver CRC Knowledge 
Build on Benefits of 
mammography to 
increase Benefits of CRC
Figure 3. Flow of TIWeb Content for Group  A (Non adherent to both CRC and BC)

 
 
Version date 1.24.2014   IRB Protocol #1009001808 
 
 D.6.2. TIWeb 
Program 
Intervention 
Pretesting: 
To validate 
narrative 
content, 
literacy level, 
and ease of 
use, 10 
women who 
meet the 
eligibility 
criteria for the 
study will 
participate in 
one of up to 
four 
Community 
Advisory 
Board (CAB) 
meetings. 
Women for the CAB will be selected in the same way as those who participate in the larger study but will be 
ineligible for the larger study. Selected participants will be representative of women in the target populations 
with regard to age and race.(130) Other qualitative methodologists(131, 132) indicate that three to five sessions are 
sufficient to achieve redundancy or “saturation” of information. The program’s usability will be evaluated by 
assessing ease of use, content (leveling and appropriateness), aesthetic appeal, and cultural relevance. The 
program will also branch women dependent on whether answers to risk factors identify them as average or high 
risk for CRC due to family history. Women at average risk will be offered options of FOBT or colonoscopy. For 
women at increased CRC risk due to family history, colonoscopy will be recommended as the most appropriate 
test. If a woman at increased risk is not interested in colonoscopy, FOBT will be offered. The interactive 
programming allows users to receive feedback after each question or short series of questions. For individuals 
in Group A (Figure 3), the program will provide messages to increase CRC screening that build on the success 
with BC screening using the common principles identified in the theoretical framework. The program will begin 
with risk messages that include age and stage of adherence. For women who are non-adherent to both cancer 
screenings (Group B), the program will branch to messages designed to promote both CRC and BC screening 
behaviors simultaneously. (Figure 4)  For both groups of women, benefits and barriers to screening will be 
individually tailored. For barriers, each individual item will be listed so that all perceived barriers can be included. 
For women who have never had previous CRC or BC screenings or for those whose answers indicate low self-
efficacy, the TIWeb will include a video of the procedures. Women receiving TIWeb will be able to observe video 
demonstrations of mammography and CRC screening tests as appropriate, and to listen to testimonials from 
health providers and survivors. Animated graphics and charts will be included. For example, for women in Group 
A, message tailoring will target CRC screening because they are already adherent to BC screening.  However, 
the message will incorporate illustrations that relate back to their adherence to BC screening. 
 
Stage 
Precontemplation 
Both BC and CRC 
Contemplation BC and 
Precontemplation  
CRC 
Precontemplation BC 
and Contemplation CRC 
Contemplation for both BC 
and CRC 
Message 
Although you haven’t 
thought about having 
breast or colon cancer 
screening in the next 
six months, there are 
very good  reasons 
why you should 
consider both of these 
tests.  As we grow 
older, both breast and 
colon cancer 
incidence increases 
but both  cancers can 
be detected early and 
cured 95% of the 
time.  This program 
will tell you more 
about both of these 
cancers including  
your risk and the 
benefits of getting 
screened. 
Although you have 
thought about having a 
mammogram, you 
haven’t really 
considered colon cancer 
screening.  Actually, the 
need for both types of 
tests is important.  This 
program will help you 
take the next step for 
breast cancer screening-
scheduling a 
mammogram-and also 
help you think about the 
need for colorectal 
cancer screening. 
You have thought about 
having colon cancer 
screening but not 
considered having a 
mammogram.    Actually, 
the need for both types of 
tests is important.  This 
program will help you take 
the next step for colon 
cancer screening-deciding 
what test is right for you 
and answering questions 
about what is holding you 
back.  We will also help 
you think about the need 
for a mammogram 
It is great that you have 
thought about having 
screening tests for both breast 
cancer and colon cancer. Your 
willingness to consider both 
these tests probably means 
that you know the occurrence 
of both cancers increases as 
we get older.  Also, both 
cancers have tests that can 
detect the cancer early when 
there is a 95% chance of being 
cured.  There are many things 
that keep us from taking the 
next step-actually scheduling a 
mammogram and colon cancer 
screening.  This program will 
help you with concerns about 
both breast and colon cancer 
screening so you can take the 
final step-scheduling an 
appointment and getting 
screened.  In fact, you can call 
the number given in this 
program to schedule both 
tests. 

 
 
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D.6.3. Tailored 
Messages: The tailoring 
for each construct occurs 
when a woman’s answer 
to a key question prompts 
delivery of the appropriate 
message. For Group B, 
several scenarios might 
present depending on a 
woman’s staging answers 
for BC and CRC 
screening. Table 2 
illustrates how messaging 
could be combined 
depending on these 
categories.  Additionally, 
depending on answers to 
a benefits question, a variation of messaging combinations could be delivered as illustrated in Table 3.  Further 
examples are given in Appendix C.  Examples of pain barriers messages for women in Group B are illustrated 
in Table 4. 
 
D.6.4. Intervention Content: Our tailored interventions will require a short initial query to obtain information that 
classifies the individual as average or higher than average risk because of family history for CRC so that the 
appropriate CRC screening test can be recommended. Mammography screening recommendations are uniform 
regardless of risk. Therefore, the telephone nurse counselors placing the CSCs must have knowledge about 
each individual’s CRC 
family history and ability to 
undergo colonoscopy prior 
to making scheduling 
appointments. The nurse 
counselor will be trained 
with an appropriate 
algorithm by our co-
investigator, Dr. Allen, to 
review participants’ 
records prior to calls to 
determine if participants 
should be excluded from a 
colonoscopy 
recommendation because 
of their health history.  
An experienced 
professional multimedia 
development firm, used in 
our prior studies, will edit 
and revise the program 
under the direction of the 
study investigators. 
Production of the TIWeb 
will include layout and 
design of navigation 
elements, background, 
color schemes, and layout of content including video, graphics, text, and animation as appropriate to this family 
practice patient population. These refined prototype interfaces will appear as complete designs. They will be 
reviewed within CAB of women in the target population (discussed in more detail below), after which the 
Table 3. Differences in Benefits Messages between Women in Group A and Group B 
Colorectal 
Cancer Screening 
Benefit Question 
Having regular 
colon cancer 
screening tests 
would help me find 
colorectal cancer 
early when it can 
be successfully 
treated. 
Breast Cancer 
Screening Benefit 
Question 
Having a 
mammogram will 
help me find BC 
early when it can 
be successfully 
treated. 
Common 
Principle 
Content for 
Benefits. 
Cancer starts as 
a single cell that 
grows more 
quickly than other 
cells. 
 
Finding cancer 
early is one of the 
best strategies for 
treating it. 
 
Almost 95% of 
early stage colon 
cancer and 
breast cancers 
can be cured 
Group A (Yes-BC& No CRC) 
You already understand the 
benefit of mammography but 
might not know that colon 
cancer starts as a single cell 
just like Breast Cancer. And it 
can grow and divide for a 
long time before you would 
be aware you had cancer. 
Just like breast cancer, if 
colon cancer isn’t found early, 
it can spread to a woman’s 
brain, liver or bones and 
when it does, it is hard to 
treat. Also just like Breast 
Cancer, if Colorectal Cancer 
is found early before it has 
spread, 95% of women are 
cured. 
Group B (No-BC&No CRC) 
Many women don’t realize it but 
both breast cancer and colon 
cancer start as a single cell that is 
so small it can’t be seen. It can 
grow and divide for a long time 
before you would be aware you had 
cancer. If either of these cancers 
isn’t found early, they can spread to 
a woman’s brain, liver or bones and 
when it does, it is hard to treat. The 
good news is that both breast 
cancer and colon cancer can be 
found early – before they spread 
and when 95% of women are 
completely cured. That’s why it is so 
important to be regularly screened 
for both breast and colon cancer. 
 
Table 4. Tailoring Barriers Messaging for Women in Group B 
Target Question 
Barrier BC 
(Group B) 
Barrier CRC 
(Group B) 
Barriers Message for Pain  
Colorectal Cancer 
Screening Barrier 
Question 
Having a 
colonoscopy would 
be painful 
No 
No 
No message 
 
No 
 
Yes 
Many people are concerned that colonoscopy may be 
painful.  Most of the time, you can be put to sleep so 
that you don’t even know what is happening.  This is 
why you will have someone come with you for the 
test.  The medicine may make you sleepy 
Breast Cancer 
Screening Barrier 
Question 
Having a 
mammogram will be 
painful. 
 
Yes 
 
No 
Most women do not find mammography painful but if 
you are worried there are several things you can do.  
Take Tylenol before coming for an appointment.  
Also-talk with the technician who does your 
mammogram.  Tell her that you are concerned and 
she will do her best to only do what is absolutely 
necessary.   
 
Yes 
 
Yes 
A lot of women put off having both a mammogram 
and colonoscopy because they have heard about 
how painful it is.  Most women do not find 
mammography painful but if you are worried there are 
several things you can do.  Take Tylenol before 
coming for an appointment..  Also-talk with the 
technician who does your mammogram.  Tell her that 
you are concerned and she will do her best to only do 
what is absolutely necessary.  As far as a 
colonoscopy-almost everyone is put to sleep so you 
shouldn’t have any pain at all.  This is why they ask 
you to bring another person to drive you home. 

 
 
Version date 1.24.2014   IRB Protocol #1009001808 
 
prototypes will be finalized. We estimate that approximately 800 unique photographs will be acquired through 
on-site photography/ videography and digital imaging libraries. Full-motion video clips (500) will be used to 
show mammography and CRC screening procedures and to present key testimonials and other material as 
media space allows. Illustrations will be multimedia firm and, if appropriate, obtained from stock illustration 
libraries. Graphics will be integrated within the interface to ensure consistency of themes(s) and user 
experience. A visual animation will demonstrate how cancer that is not detected early can grow and spread 
through the body. Animation will also be used within charts or graphs to emphasize important elements, and 
animated icons and sound designed by the will be incorporated throughout the program to enhance the look, 
feel, consistency, and usability of the program. All pages will have spoken (audio) dialogue with the same 
information repeated in the form of written text, allowing women with low literacy to use the program. Our goal 
is to create a tailored  
TIWeb program that is narratively rich 
and applicable to women at all levels of 
education. 
D.7. Cancer Screening Call. (CSC) A 
computer interface will act as a 
counseling guide, but nurse counselors 
will have flexibility in responding to 
individuals’ questions based on the 
conversation flow. Our team is 
experienced in training counselors to 
use these guides without seeming 
“rote” or “stiff” in presentation. The 
conversational tone of messages in the 
program, combined with flexibility of 
counselors to paraphrase and answer 
questions, has assured a pleasing 
presentation.  The telephone nurse 
counselor will call individuals 
randomized to the CSC alone to 
schedule the telephone counseling call 
after they have been consented and 
baseline data collected. The call will be 
placed within 1 week of randomization. 
For individuals who are randomized to 
the TIWeb+ CSC, the TIWeb will be 
mailed after randomization and the 
telephone nurse counselor will call 1 
week after this mailing.  The follow up 
data collection will occur at 4 weeks 
post intervention. 
 Interpersonal communication 
interventions using telephone 
counseling have demonstrated 
significant increases in cancer screening compared to usual care. Telephone counseling is interactive and 
provides a mechanism to provide conversation between a trained nurse counselor and a recipient. The Cancer 
Screening Call (CSC) intervention in this proposal will use the same theoretical constructs present in the TIWeb-
perceived risk, benefits, barriers, and self-efficacy.  Although intervention content is similar in both the 
TIWeband CSC, the delivery varies.  Both use an interactive format in which women are queried about content 
and then messages delivered specific to that content.  The TIWeb allows use of video, graphs and other media 
not available in the CSC.  The CSC, however, allows individual message clarification in real time.  Both the 
TIWeb and the CSC will offer scheduling of the screening tests without a prior visit.  In the TIWeb program, a 
dedicated number will allow participants to call for scheduling appointments.  In the CSC arm, nurse counselors 
Table 5. CSC Intervention Objectives, Constructs and Content 
Construct  
Objective 
Telephone Counseling Content  
Time Mins 
Intro 
Establish 
rapport 
• Identification of Counselor as 
nurse 
• Verify participant identification 
• Review purpose of call   
• Identify adherence and stage 
with BC and CRC 
1 
Objective 
risk 
Identify 
objective risk 
• Assess family hx 
• Information about individual risk  
3 
Knowledge  
Increase 
knowledge of 
CRC & BC 
screening 
options 
depending on 
individual risk 
and choice 
• Assess knowledge of options 
• Clarify misconceptions 
• Answer questions 
• Provide options of FOBT or 
colonoscopy and mammography 
for Average Risk individuals and 
colonoscopy and mammography 
information for High Risk 
individuals  
5 
Benefits  
Increase 
benefits of 
CRC & BC 
screening 
• Information about benefits 
• Clarifying misconceptions 
• Answer questions  
2 
Barriers to 
selected 
CRC 
screening 
option  
Reduce 
perceived 
barriers to 
colonoscopy, 
mammograph
y or FOBT 
• Assess barriers 
• Counsel on barriers identified 
5 
Access 
Enhance 
access to 
selected CRC 
& BC 
screening 
option 
• Mail FOBT 
• Assist with scheduling colonoscopy 
2 
Conclude 
Summary for patient activation of CRC & BC screening guidelines 

 
 
Version date 1.24.2014   IRB Protocol #1009001808 
 
will offer to mail FOBT cards and schedule colonoscopies and mammograms at the end of the CSC. The 
objectives and content related to each common theoretical variable are listed in Table 5.  
D.8. Intervention Delivery.  Women randomized to any of the four groups will receive a baseline call and a 
call at 4 weeks and 6 months for data collection. Women randomized to the TIWeb alone group will receive a 
letter and an email with information that will detail how to enter the TIWeb within one week after completing the 
baseline survey. Women randomized to the CSC call will be scheduled to receive the CSC call within one 
week of baseline survey. For women randomized to the  combination group (TIWeb + CSC), the a letter and an 
email that details how to enter the TIWeb within the next week. One week after mailing and emailing the 
information on entering the  TIWeb, the CSC will be placed. Individuals will first be asked if they received the 
letter and/or email detailing how to enter the TIWeb and if they viewed the TIWeb. Prior to delivering the 
scripted CSC, women will also be given the opportunity to ask any questions that have arisen from watching 
the TIWeb.  The TIWeb will contain both programs for women who are adherent to BC screening but not to 
CRC (Group A) or nonadherent to both (Group B). A trained research assistant will be available by phone to 
provide technical assistance to any women who needs help using the TIWeb. Because CRC screening 
recommendations vary depending on risk factors, a risk algorithm will be incorporated into the TIWeb and CSC 
to identify women at average risk or at increased risk due to family history. Women at increased risk will be 
reminded that colonoscopy is the best test for them, if it is not contraindicated. If their risk is average, a choice 
of either FOBT or colonoscopy will be presented. If women are uncertain about which method would be best 
for them, they will be encouraged to schedule an appointment with their primary health care provider to discuss 
options for screening. Scheduling of colonoscopy or mammography via telephone will be offered to all women 
in the intervention groups. Women receiving only the TIWeb will have a dedicated number to call and schedule 
colonoscopy or mammography, or to receive an FOBT kit in the mail.  If the woman is an appropriate 
participant and wants to schedule an appointment for CRC or BC screening, it can be completed while on the 
call. If the patient requests an FOBT kit, it will be mailed immediately following the call. BC screening 
recommendations do not vary; therefore, a message will encourage yearly mammography for all women. 
Within the family practice research network, usual care consists of preventive services for women performed 
during the physical including regular Pap and pelvic exams. As part of the annual exam, the primary care 
physician reviews the current age-appropriate screening guidelines for the patient and suggests that these be 
done. Most hospital systems or radiology clinics also notify the patient when a mammogram is due.  
D.9. Training for Interviewers and CSC Nurse Counselors. Graduate nurses will be hired and trained as 
counselors to complete the CSCs. The nurse counselors will have an initial training session consisting of the 
following elements: 1) project rationale and overview, 2) detailed information about each intervention, 3) delivery 
practice, 4) a detailed training manual, 5) an extensive question-and-answer period, and 6) breakout for 
individual training roles and training to use an algorithm developed by Dr. Allen to determine eligibility for 
colonoscopy.  Nurse counselors will be trained to appropriately answer spontaneous questions that occur either 
during telephone interviews or during telephone counseling. Nurse counselors who conduct telephone 
counseling calls will have all calls recorded. Responding to impromptu questions will be an important part of 
training so that standardization can be achieved. Role play will be especially important in learning to respond to 
questions. We will have four hours of role play in which mock participants will challenge nurse counselors with 
extraneous questions. The nurse counselors for the CSCs will be continuously recorded for quality assurance. 
The role-playing and taped interviews will be evaluated based on a checklist contained in the Appendix A. Initial 
training will be conducted during a two-day session. The first day will consist of presentations including the 
following: 1) overview of grant objectives and rationale; 2) detailed demonstration of intervention arms; 3) 
protection of human subjects and confidentiality issues; and 4) practice in answering impromptu questions.  
The Center for Survey Research in Bloomington, by phone or electronically survey, will collect T1, T2, and T3 
data and provide any technical assistance needed with the TIWeb. Participants who have questions about the 
TIWeb will be able to call a toll free number and a research assistant will call them back. The additional contact 
will be recorded for length of time and content and added as a covariate to final analysis. Extensive training will 
be required for all research assistants who collect data and provide technical help with the TIWeb. Research 
assistants who provide the CSC will be different individuals than those who do telephone interviews so that 
bias will not be introduced during data collection. Research assistants will be graduate students who will have 
an initial training session consisting of the following elements: 1) project rationale and overview, 2) detailed 
information about each intervention, 3) information about assisting women with the TIWeb, 4) delivery practice, 

 
 
Version date 1.24.2014   IRB Protocol #1009001808 
 
5) a detailed training manual, 6) an extensive question-and-answer period, and 7) breakout sessions for 
individualized role training. Although interviewers won’t be blind to assignment, training will include extensive 
focus on standardizing the interviews.  
D.10. Process Evaluation. Process evaluation for accrual will be determined by randomly selecting 25% of all 
accrual calls and rating callers using the evaluation checklist in Appendix A. Research assistants that receive 
below average on any criteria will be given additional training.  
 Consistency in intervention delivery is assured through the standardized programming used in the computer-
assisted CSC and through taping and review of CSCs. The TIWeb guide the participant through all sections. 
The CSCs will be continuously recorded for quality assurance. Monthly taping of at least one TIWeb technical 
assistance session and T1, T2, and T3 interview for each interviewer will allow checks on consistency of 
performance. Taped interviews and CSC calls will be evaluated based on a checklist contained in Appendix 
A. Research assistants who are not delivering calls as instructed will be given additional training. Research 
assistants will address any unusual happenings during biweekly meetings. Decisions to modify procedures will 
be made jointly and documented. The research team will meet monthly to discuss any concerns with 
implementation of the protocol or collection of interview data. The principal investigators will meet weekly to 
refine the protocol and training procedures and to discuss ongoing issues. 
 D.11. Measurement. Major outcome variables, 
delineated in Specific Aims, include: 1) Adherence 
and staging for CRC and BC, and 2) Cost-
effectiveness.  
The adherence to screening recommendations 
outcome will be assessed at 4 weeks and 6 
months after intervention. As indicated in Table 7, 
the 4 week data collection will only be self report.  
Mammography and CRC screening and 
diagnostic tests at 6 months are the primary 
outcome and will include using claims data that 
identifies both screening and diagnostic codes in 
medical records as some test may be labeled 
diagnostic.  
FOBT is not always charged to the patient. 
Therefore, verification of FOBT will require 
medical chart audit.  A woman may not have a 
screening reported in her claims data because 
she is new to the health plan and received 
screening elsewhere. It is also possible that 
women may switch health plans or use another 
site for other reasons. Therefore, use of self report in addition to claims data, and medical record audits will 
provide necessary outcome data. Participant involvement and beliefs will be assessed at 4 weeks post-
intervention.  As described previously, we may have women in the study who are at increased risk for CRC due to 
family history.  For these women, colonoscopy is the most appropriate CRC screening test.  However, some of 
these increased-risk women may decide to do FOBT instead of colonoscopy.  In order to identify all behaviors, we 
will divide adherence to CRC screening into two categories-Risks Appropriate, and Any CRC screening after 
intervention.  For most women who are at average risk, these classifications will be the same.  However, for women 
with a family history of CRC, Risk-Appropriate CRC screening would be colonoscopy.  Table 6 defines each 
outcome. Data assessment times are specified in Table 7. Data collected for cost-effectiveness are described 
under the cost-effectiveness section. 
 
 
Table 6. Measurement of Outcomes: Stage and Adherence 
for BC and CRC 
 
Stage 
CRC Screening 
Average risk 
woman 
CRC screening 
At higher risk 
because of 
family history 
 
BC Screening 
Precontemplation Is nonadherent to 
national 
guidelines and  
does not intend 
to have one of the 
test options in 
next 6 months 
Never had a 
colonoscopy or 
had one > 10 
years ago and 
does not intend 
to have one in 
next 6 months 
Never had a 
mammogram or 
had one > 15 mo. 
ago and does not 
intend to have one 
in next 6 months 
Contemplation 
Is nonadherent to 
national 
guidelines  but 
intends to have 
one of the test 
options in next 6 
months 
Never had a 
colonoscopy or 
had one > 10 
years ago and 
intends to have 
one in next 6 
months 
Never had or had 
mammogram 
more than 15 
months ago but 
intends to have 
one in next 6 
months 
Action 
(Adherence to 
any CRC 
screening) 
Had one of the 
test options since 
intervention  
Had one of the test 
options since 
intervention 
Had a 
mammogram 
since intervention 
Action 
(Adherence to 
risk appropriate 
CRC screening 
Had one of the test 
options since 
intervention  
Had a 
colonoscopy 
since intervention  
Had a 
mammogram  
since intervention 
Table 7: Data Assessment 
Variable 
Baseline 
4 Weeks 
6 Months 

 
 
Version date 1.24.2014   IRB Protocol #1009001808 
 
 
 Stage of  Adoption for CRC and BC Screening: 
Stage will be identified using measures of Prochaska 
and DiClemente’s Transtheoretical Model developed 
for mammography by Rakowski and colleagues(119, 
128) and consistent with our previous research.(9, 10) Construct validation for these stage measures was established 
via principal components analyses in an original and a replication study (involving 142 and 676 women, 
respectively).(119, 128) Items for CRC and BC screening will determine whether participants: 1) have ever had a 
mammogram, FOBT, sigmoidoscopy, or colonoscopy; 2) have thought about having a mammogram, FOBT, 
sigmoidoscopy, or colonoscopy; or 3) intend to have any of these tests in the next six months. We will also ask 
participants if CRC or BC screening tests were for screening or diagnostic purposes and use their responses as 
a covariate. Screening and diagnostic procedures have different CPT codes. 
 Mammography and colonoscopy scheduling will be based on the location of the participating physician.  The 
study team will be given a preferred list of sites to be scheduled as well as alternative sites if the patient chooses. 
Results of screenings will be sent immediately to the participant’s primary health care provider as part of her 
routine care.   
 Past Screening History will be measured by self-reported items that assess CRC and BC screening tests women 
have had in the past 20 years or since the individual turned 50. Self-report will be the most feasible method to 
assess screening history since claims data may not accurately reflect all screening tests done in other health 
care settings or while they were covered by a different health insurance plan.  
 Participant Involvement: will be measured for the TIWeb and for the CSC. The participant involvement scale 
for TIWeb has 19 items that address interest and engagement in the program and its content. The items, 
piloted with 36 people (see Preliminary Studies), address ease of use, relevancy, information content, barriers, 
and general satisfaction. The Cronbach’s alpha was 0.89 and 100% of people indicated that they found the 
program interesting, easy to use, easy to understand, and containing information that was important to them. 
The survey instrument can be found in Appendix E. There are 15 items that measure participant involvement 
in the CSC. Participants will be called within 4 weeks following intervention to obtain data on involvement with 
the intervention. 
Beliefs about CRC or BC Screening 
Perceived risk, benefits, barriers, and self-efficacy measures for BC screening have been extensively tested 
and refined since 1984.(133-135) Validity was tested using confirmatory and exploratory factor analysis and 
known groups’ technique. Internal consistency (0.87) and test-retest reliability (.60) were also computed.(134) 
Parallel scales to measure CRC screening have been tested for validity and reliability and results recently 
published.(136)  
Perceived Risk (BC & CRC): Perceived risk for BC includes four items with a reported internal consistency 
coefficient of 0.87 and test-retest reliability of .67.(134) The items measure beliefs about the participant’s 
perceived risk of getting BC in the future. Perceived risk for CRC includes four items, a 3-item scale developed 
by Dr. Champion and a single-item measure designed to assess perceived age-adjusted risk. The summated 
risk scale was originally developed for BC(135) and adapted to CRC.(137) Validity and reliability have been 
extensively tested with diverse population groups. Internal consistency reliability analyses from previous studies 
yielded Cronbach’s alphas ranging from 0.75 to 0.77. 
 
Benefits (BC & CRC screening) Dr. Champion has developed a four-item “Benefits to Mammography” scale that 
assesses women’s perceptions of mammography’s ability to find BC early and avert death. In a past study,(134) 
the scale showed an internal consistency alpha of .75 and test-retest reliability of .59. Benefits of FOBT (3 items) 
and colonoscopy (4 items) will be measured separately using  summated Likert scales modified from those 
previously developed to measure BC screening benefits.(135) Items specific to CRC screening have been 
identified in the literature and through focus group discussions and were psychometrically tested.(136) The 
Cronbach’s alpha coefficients obtained in a preliminary study for 5-item scales measuring benefits of FOBT 
and colonoscopy were 0.65 and 0.70, respectively. 
 
Barriers (BC & CRC screening): Barriers to mammography are measured on a 12-item scale developed by Dr. 
Champion.(133-135) The internal consistency coefficient was 0.88 and test-retest coefficient was 0.72. Information 
Self Report CRCS and BCS 
X 
X 
X 
Screening Record verification 
X 
 
X 
Knowledge and Beliefs 
X 
X 
 
Participant Involvement 
 
X 
 
Demographic Variables 
X 
 
 

 
 
Version date 1.24.2014   IRB Protocol #1009001808 
 
on all items will be collected, although tailoring will be based on barriers found to be most relevant in prior 
work. Barriers to  FOBT and colonoscopy will be measured by separate summated Likert scales modified from 
those previously developed to measure BC screening barriers.(135) Items specific to CRC screening have been 
identified in the literature and through focus group discussions and were psychometrically tested in preliminary 
studies.(138) Barriers to FOBT are assessed using a 9-item scale and barriers to colonoscopy with a 15-item scale, 
all with the same 5 Likert response options. Internal consistency reliability (alpha) coefficients of the barriers 
scales for FOBT and colonoscopy were 0.72 and 0.77, respectively. 
Self-efficacy (BC & CRC screening): Self-efficacy for mammography is measured on a 10-item scale 
developed by Dr. Champion and has been tested for reliability and validity.(123) The internal consistency 
reliability was 0.91, and all items loaded at 0.60 or above in a unidimensional factor structure. Significant 
differences on scale scores emerged between adherent (mean=42.74) and nonadherent (mean=40.74, t=3.07, 
p<.003) women. Further validity and reliability testing will be conducted in the proposed study. Self-efficacy for 
FOBT and colonoscopy will be measured independently using 12-item scales that use a Likert response scale 
Self-efficacy scores for FOBT and colonoscopy scales had internal consistency reliabilities of 0.90 and 0.92, 
respectively, in a previous study.(139) 
 Knowledge (BC & CRC): BC knowledge will be measured using a scale developed by Dr. Champion in 
preliminary studies. The scale had an internal consistency reliability of 0.77. Knowledge about CRC will be 
measured using a multidimensional scale that has been tested in preliminary studies and found to have 
content and construct validity. Several aspects of knowledge about CRC will be assessed, including risk 
factors, screening, and treatment. 
Demographic/Medical History/Insurance Variables/Personal Experience/Media Exposure: will be assessed 
using the form in Appendix F. Questions will assess age, race, education, and marital status. These items 
have been used for descriptive reporting in our previous research without interpretation or scoring difficulties. 
In the proposed study, questions about personal experience will relate to previous information about 
mammography screening experiences or to information gathered during the grant period. Women will also be 
asked about experiences with close friends or relatives with cancer. Participants will be queried regarding any 
CRC or BC screening recommendations or counseling outside of the study protocol. Women will also be 
queried about out-of-pocket cost for any BC and CRC screening. Cost-effectiveness will be measured and 
calculated as described under the Data Analysis section. 
Overall Functioning: will be assessed using the Medical Outcomes Study - Short Form 12 (SF-12®), a 12-item 
scale that yields summary physical and mental health outcome scores that are interchangeable with those from 
the SF-36®. The SF-12®, published in early 1995, is one of the most widely used instruments that reproduces 
the SF-36® physical and mental health summary scales (PCS and MCS) as well as the eight subscales of the 
original SF-36. Reliability and validity have been well supported; test-retest reliabilities of 0.89 and Cronbach 
alphas of 0.76 are reported.(140) 
Cost-effectiveness will be measured and calculated as described under the Data Analysis section. 
D.12. Sample Size and Power Analysis: The primary efficacy hypothesis in this area of research is adherence to 
screening. Therefore, adherence to CRC and BC screening at 6 months has driven our choice of sample size.  
Originally, we proposed conducting analysis with two separate groups based on initial mammography status:  
1) women who were adherent to mammography but not to colorectal cancer (CRC) screening, and 2) women 
who were adherent to neither mammography nor CRC screening.  By testing these groups separately, we 
required a sample size of 2616 to achieve 80% power between both the control and intervention groups and 
between any combinations of groups.  In re-considering this approach, we realized that since the outcome of 
CRC screening was common across both groups A and B, this was not the most efficient design to test our 
outcomes.  We are proposing analyses using one group of women, all of whom will be non-adherent to CRC 
screening at baseline.  In this group, some women will be adherent to mammography guidelines (i.e., had a 
mammogram in the past 15 months) and others will be non adherent. For Aim 1, when we examine 
intervention effects on the outcome of CRC screening, we will control for baseline adherence to 
mammography.  For Aim 2, we will use only the sub-group of women who were not adherent to either breast or 
CRC screening at baseline.  Using this approach will reduce the sample size needed and reduce the overall 
costs of the study, more closely aligning the budget with the amount awarded.  Most importantly, revising our 
analytical approach will enable us to achieve our initial Aims despite the reduced sample size.   

 
 
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Specifically, for the outcome of CRC screening adherence, we had justified sample size in the original proposal 
to achieve 80% power to detect differences between intervention groups, separately for two groups of women 
depending on their baseline breast cancer screening adherence status.  
Group A includes women who were nonadherent to CRC screening but adherent to BC screening, and  
Group B includes women nonadherent to both CRC and BC screening. 
 
We realize now that it is unnecessary to perform the analysis of CRC adherence separately for the two groups 
(A and B). Instead the Group variable (A vs B) can be entered in the model using baseline mammography 
screening as a covariate.    
 
In Table 8 of the original application (see appendix), we proposed enrolling 327 for each of 8 combinations of 4 
arms and 2 groups (A and B) for a study total of 2616. However, using this alternative approach will require only 
1308 (327 in each of the 4 arms) women to test the primary outcome of CRC adherence.  However, new 
studies, including our own, indicate 15-20% adherence to CRC screening in control conditions. Our initial 
proposal anticipated on 10% adherence in the control arm.   Thus, although the new design decreases the 
sample size by combining the groups, a more realistic estimate of the adherence in the control group will 
actually increase the sample size compared to our estimate in Group A for the initial proposal. Specifically, we 
propose to increase our estimate of CRC adherence in all four arms, to accommodate a change in the proposed 
adherence in the control group from 10% to 20%. This will require 397 instead of 327 per arm (see Table 1). 
Thus, a sample of 397 per group at baseline (357 per group at 6 months after 10% estimated attrition) will 
provide 80% power to detect differences between any pair of the four randomized arms for Aim 1 (Table 1).  
 
Revised Sample size and Power analysis for primary efficacy hypothesis of estimated CRC screening 
adherence rates in the combined groups of those adherent (Group A) and non-adherent (Group B) at 
baseline to breast cancer screening (Aim 1, primary outcome of CRC adherence) 
 
GROUPS A and B combined 
Time 
Usual Care (1) 
TIDVD (2) 
CSC (3) 
TIDVD+CSC (4) 
Power 
Baseline adherence 
Total sample size (N): 
 
N by baseline strata, 
Adherent to BC (A) 
Non-adherent to BC (B) 
0% 
(n = 397) 
 
 
(n = 119) 
(n = 278) 
0% 
(n = 397) 
 
 
(n = 119) 
(n = 278) 
0% 
(n = 397) 
 
 
(n = 119) 
(n = 278) 
0% 
(n = 397) 
 
 
(n = 119) 
(n = 278) 
NA 
6 months adherence 
Total sample size (N): 
 
N by baseline strata, 
Adherent to BC (A) 
Non-adherent to BC (B) 
20% 
(n = 357) 
 
 
(n = 107) 
(n = 250) 
30% 
(n = 357) 
 
 
(n = 107) 
 n = 250) 
40% 
(n = 357) 
 
 
(n = 107) 
(n = 250) 
55% 
(n = 357) 
 
 
(n = 107) 
(n = 250) 
Power for 357/arm 
(Groups A and B 
combined) 
1v2  .87 
1v3  .99 
1v4  .99 
2v3  .80 
2v4  .99 
        3v4  .98 
 
Enrollment will be stratified by women adherent to breast but not CRC screening and those adherent to neither 
in a 30%/70% ratio so that we will have an adequate sample to detect an 80% power for Aim 2.  Aim 2 will use 
only the subgroup of women who are not adherent to either breast or CRC screening. This will provide at least 
80% power for Group B for comparing each pair of randomized arms, when testing the secondary outcome 
(adherence to both CRC and BC screening) (Table 2). 
 
Thus, the hypotheses for Aim 1 can now be conceptualized as  
 
Aim 1: 
Hypothesis 1 (Primary outcome): There will be differences in CRC screening  adherence and stage of 
adoption, when controlling for adherence to BC screening at baseline, among women who are randomized to 
1) usual care; 2) a TIDVD; 3) a CSC, and 4) a TIDVD plus a CSC.  

 
 
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Aim 2: 
Hypothesis 2 (Secondary outcome): In the group that is nonadherent to both CRC and BC screening at 
baseline, there will be differences in adherence to both CRC and BC screening and stage of adoption, among 
women who are randomized to 1) usual care; 2) a TIDVD; 3) a CSC, and 4) a TIDVD plus a CSC. 
 
 
 
D.13. Analyses. Descriptive statistics will be computed for all variables, using stem-and-leaf plots, central 
tendency indices, variability indices, and frequency distributions. We will compare demographic information at 
baseline across the four randomized groups (usual care, TIWeb, CSC, and TIWeb + CSC), using the analysis 
of variance (ANOVA) for continuous variables (describing with means and standard deviations) and using the 
Pearson chi-square test for categorical variables (describing with cross-classification tables). If the ANOVA 
parametric assumptions of normality and equal variances are not met, we will perform the nonparametric 
Kruskal-Wallis test for the continuous variables. If there are significant baseline differences between the two 
intervention groups at a liberal significance level of 0.20, we will adjust for those characteristics in subsequent 
logistic regression analyses.  
 
Aim 1: Analysis for intervention efficacy:  Women in Group A women are nonadherent to CRC screening 
but adherent to BC screening at baseline and thus could become adherent to CRC screening. Depending on 
whether a woman is at increased risk (due to family history) or average risk, we will code each participant as 
risk-appropriate adherence or adherence to any CRC screening.  For women at average risk, these categories 
will be identical.  For women at high risk, completion of a colonoscopy is needed to classify them as adherent 
to the risk-appropriate test.  Thus, two outcomes will be tested in relation to CRC adherence: 1) adherence to 
any CRC test; and 2) adherence to a risk-appropriate test.  Women in Group B will be nonadherent to both 
CRC and BC screening at baseline and thus could remain nonadherent to both, become adherent to one, or 
become adherent to both screenings.  
 
Group A (nonadherent to CRC but adherent to BC screening guidelines) 
 
Hypothesis 1- Efficacy Analysis: The differences in binary adherence across the four randomized arms will 
be tested initially with the chi-square test for a 2x4 cross-classification table (adherence by randomized 
intervention groups). Binary logistic regression analysis, with three dummy variables using usual care as the 
reference category, will be computed to study the effects of each intervention (TIWeb, CSC, TIWeb +CSC) 
versus usual care on adherence, while adjusting for any potentially confounding covariates. In addition, model 
contrasts will be specified to statistically compare each of the three intervention arms to the others. Since the 
intervention is delivered to the patient and not the provider, analysis of variation in CRC screening by 
practitioners will be limited. Outcomes of patients who share the same providers may be slightly more 
correlated than outcomes of patients from different providers. Thus, the within-provider correlation among 
patients will be assessed with variance components, and if necessary generalized estimating equations (GEE) 
will be used with logistic regression to account for the within-provider correlation. We will enter as independent 
variables into logistic models the following: randomized group membership and any demographic covariate 
(age, race, education, marital status, screening history, baseline stage of adoptions, SF12 mental health 
component, SF12 physical health component) for which the randomized groups differ significantly at baseline 
using a liberal significance level of 0.20. We will also measure whether subjects report that their physicians 
have recommended the screening test in the past and the amount of out-of-pocket expense for screening and 
enter these as covariates. In addition to demographic variables, other potential covariates will be location of 
TIWeb intervention (use of a computer at home or elsewhere), and whether women in the TIWeb group 
needed technical help from the research assistant to use the TIWeb program. We plan to include screening 
history as a covariate in our analysis by using the total number of past screenings for each test since the 
participant turned 50. For analysis with mammography screening, one covariate will be included (total number 
of mammograms since age 50). For the analysis of CRC screening, two covariates will be included 
simultaneously in the models (total number of FOBTs since age 50, and “any previous endoscopic test” 
[yes/no]). The CRC screening analysis requires two covariates because a history of five FOBTs, for example, 
is not equivalent to one previous FOBT and one previous colonoscopy or sigmoidoscopy. All variables in the 

 
 
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logistic regression models will be tested using the likelihood ratio test.(141) Adjusted odds ratios and profile-
likelihood-estimated 95% confidence intervals for those odds ratios will be provided.  
Analyses of stage of screening will be the same as analyses above for adherence, except that the binary 
outcome is advancement (from baseline) in stage of adoption for CRC screening guidelines. There are two 
possible stages of adoption at baseline (precontemplation and contemplation) and three possible stages at 6 
months (precontemplation, contemplation, and action). Thus, there are four possible stage movements from 
baseline to 6 months (fall back one stage, remain the same, advance one stage, or advance two stages). 
However, data on a large sample in the Preliminary Studies demonstrated that, of 904 women followed to 9 
months post-baseline, only 4% of women fell back one stage and only 6% advanced two stages; the majority 
either advanced one stage (50%) or remained the same (39%). Therefore, we will implement the outcome of 
stage change as a dichotomous variable: improvement (advance one or two stages) versus no improvement 
(remain the same or fall back one stage). 
Group B (nonadherent to both CRC and BC screening guidelines) 
Hypothesis 1- Efficacy Analysis: Similar to the approach in Hypothesis 1 for Group A, screening adherence 
across the four randomized arms will be tested initially with the chi-square test for a 2x4 cross-classification 
table and then adjusting for covariates in logistic regression models. However, the statistical procedures will be 
generalized versions (Mantel chi-square and ordinal logistic regression) to accommodate an ordinal outcome. 
The three possible ordinal responses for the outcome are: 1) no adherence, 2) adherence to either CRC or BC 
screening, and 3) adherence to both CRC and BC screening. Specifically, we will perform: a) the Mantel chi-
square test of linear trend and the Liu-Agresti ordinal odds ratio (the latter is a contingency-table-based statistic 
but assumes proportional odds) on a 2 x 3 cross-classification table (intervention group by ordinal adherence), 
and b) ordinal, instead of binary, logistic regression models. If the assumption of proportional odds is not 
satisfied, a more general logistic regression model, the generalized logit model, will be employed, and two 
odds ratios, instead of a single Liu-Agresti odds ratio, will be reported for the classification tables. Analyses of 
stage will be the same as for adherence, except the three possible ordinal responses would be based on 
improvement (from baseline) in stage of adoption: 1) no improvement in stage, 2) improvement in stage of 
either CRC or BC screening, and 3) improvement in stage of both CRC and BC screening. The Preliminary 
Studies show we have a great deal of experience analyzing outcomes of screening adherence and stage 
improvement, for both BC and CRC outcomes. 
Aim 2: Analyses for cost effectiveness is described next. To conduct cost-effectiveness (CE) analysis of a 
cancer screening program, it is necessary to determine both the effectiveness of a given intervention (as 
measured by the achieved outcomes) and the costs of providing the intervention to both groups A and B. The 
cost-effectiveness analysis will be conducted from the perspective of both the provider and the participants.  
Program Effectiveness: The main effect is screening compliance at 6 months from the baseline measure as 
determined by the randomized trial. For those in Group A, CRC screening is the outcome. For Group B, there 
are three outcome groups: CRC screening adherence, BC screening adherence, and adherence to CRC and BC 
screening. Outcomes will be determined with an “intent-to-treat” analysis by analyzing data from all women who 
originally consented and were randomly assigned to a research arm regardless of deviations from the protocol, 
the degree of treatment they received (e.g., regardless of whether TIWeb was viewed or CSC was made), or 
withdrawal from treatment or loss to follow-up. The use of claims data and medical records data for the main 
outcome of adherence will make it possible to analyze adherence at 6 months even for women who dropped out, 
as long as claims data for those women can be obtained.  
Program Costs: To calculate the costs of the interventions, we will consider delivery costs only. Costs associated 
with research and development (R&D) activity or costs of screening tests are excluded. The cost of developing 
the TIWeb is expected to be a major pre-intervention R&D cost. Researchers have debated how to handle these 
“first-copy” costs and there is no universally accepted “correct” answer. First-copy costs, defined as costs 
incurred in establishing a regimen or intervention, are considered quasi-fixed costs independent of the number of 
units produced, once production is started. Generally, first-copy costs are excluded when they involve situations 
in which much of the intervention is already in existence and only modification is needed to adapt it for 
implementation. While R&D costs can be high, they are “sunk cost” from a societal perspective, in any future 
decision to implement the interventions. The final product developed for this study could be made available to 

 
 
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other organizations.We expect managed care organizations would not develop their own TIWeb, but would rely 
on public access or licensing arrangements to secure such educational material. However, the cost of developing 
the TIWeb will be calculated to inform future developers of the approximate cost of developing this type of 
interactive technology for health promotion interventions and to test CE analysis with and without these costs. 
The total costs of an intervention include both direct and indirect costs. Direct costs are those directly related to 
services provided to the participants and include such inputs as personnel time, supplies, postage, and capital 
equipment. The total cost of a specific intervention will be based on several inputs including: the cost of 
personnel ( time needed to provide the intervention multiplied by the salary and benefit cost); the cost of 
nondurable, consumable supplies (quantity consumed times the unit price); and the cost of durable capital 
equipment (depreciated over the expected life of the asset, to reflect annual costs).Postage will be a non-trivial 
cost in this study since some of the correspondence with participants will be by mail. Ancillary miscellaneous 
costs (printing, workstation design, space rental, phone charges, etc.) will be obtained from the project’s 
monthly expenditures. Incentives used in this study to secure cooperation of the participants will not be 
considered a cost of the intervention since these are considered research costs and not a necessary ingredient 
of the interventions. Incentives are provided for data collection and not for participation in an intervention. 
Overhead costs, including housekeeping, administration costs, rent, building and equipment depreciation, 
insurance expenses, and utilities are very difficult to allocate to the appropriate intervention without developing 
a detailed accounting procedure, which is beyond the scope of this project. Therefore, overhead costs will be 
estimated by a percent of direct cost, based on previous health promotion studies. The base case indirect cost 
rate will be 30 percent of direct cost.(142) Participant time costs (the time a woman spends participating in the 
intervention) will be included in the cost figures since participant time has value from a societal perspective.  
Participant time will be valued by the national median wage rate (http://www.bls.gov/bls/blswage.htm) 
Participant time cost will be excluded when computing costs from the provider perspective.  
Direct costs (labor, supplies, postage, and equipment) will be determined for each of the two interventions 
through resource utilization monitoring of daily consumable materials, travel expenses, labor/time activity logs, 
and equipment expenses to track individual intervention costs. An on-going accounting of the work effort and 
materials required to complete an intervention will be determined from daily activity logs kept by project staff 
(see Appendix E). The total cost of a specific intervention will be based on the cost of labor (labor time needed 
to provide the intervention multiplied by the salary and benefit cost), plus the cost of the consumable supplies 
and ancillary costs (printing, phone charges, etc). The resulting amount will be the estimated cost of providing 
each intervention. We expect that the TIWeb + CSC costs will be higher than the TIWeb or CSCs alone costs, 
since different labor costs will be incurred with the two interventions. Costs will not be discounted to a present 
value because we are attempting to determine the relative efficiency of operating the alternative interventions 
on an ongoing basis. Substantial capital equipment will be amortized over the expected life based on a 3 
percent rate of interest. 
Bundling screening promotion services to promote multiple screening tests for women in group B presents a 
special cost problem due to the difficulty of allocating cost to specific outcomes. The main difference in cost 
between participants in Group A and those in Group B will be participant time and telephone counseling time 
required to communicate information about two versus one type of screening. These costs will be directly 
allocated to the screening interventions by tracking time for each participant. Other implementation costs will be 
the same for subjects eligible for either one test or two screening tests (e.g., recruitment). For group B, we follow 
methods employed by Chirikos et al. (2004)(143) to adjust the cost estimate for subjects eligible for two screening 
tests. In their study of an office-based primary care tracking system to increase screening for breast, cervical, and 
colorectal cancer, they apportioned the cost to subjects based on the number of tests they were eligible for. If a 
participant was eligible for two screening tests, they were assigned ½ of the intervention cost and the full 
intervention cost if they were eligible for only one test. Thus, cost for participants in group B will consist of directly 
allocated cost for their time and nurse counselor time and other costs apportioned by the number of tests for 
which they are eligible (see equations below).  
Cost-effectiveness Analysis: The cost-effectiveness evaluation is examined from the societal perspective 
and from the more limited perspective of the provider to inform future decision-makers about the relative 
efficiency of the alternative interventions. The analysis focuses on the incremental cost per additional individual 
who is adherent (i.e., has a CRC, BC, or both screening tests during the observation period) for each 
alternative intervention. The intervention costs will include participant time costs and resource costs and be 

 
 
Version date 1.24.2014   IRB Protocol #1009001808 
 
valued in 2010 constant U.S. dollars. This focus is consistent with the recommendations of the Report of the 
Expert Panel on Cost-Effectiveness in Health and Medicine.(144) The base case will be defined as the estimate 
of costs and effects derived from the best point estimate of intervention parameters. Planning, implementation, 
and participant costs will be tracked for the interventions.  
The primary cost-effectiveness measures will be the incremental cost-effectiveness ratios (ICERs) obtained by 
dividing the additional per target individual cost by the additional percent of target individuals who are screened 
by the end of the follow-up period, comparing the control group to the TIWeb group, to the CSC group, to the 
TIWeb+CSC group moving from the least resource-intensive to the most resource-intensive interventions 
(equations 1,2,3). These measures will be based on intention to treat methods and correspond to the 
observation period of the study.(145) 
Group A (cost fully allocated to BCS intervention) 
 
 
 
 
 
 
 
 
Group B (cost adjusted for joint production) 
 
         BCS: (directly allocated plus 1/2 of non directly allocated cost applied to BCS intervention)  
 
 
 
 
 
 
 
          CRC: (directly allocated plus 1/2 of non directly allocated cost assigned to CRCS intervention) 
 
 
 
 
 
 
 
         BCS & CRCS: (all costs allocated to joint BCS & CRCS intervention)  
 
 
 
 
 
 
The effects on the ICERs of methods and parameter uncertainty will be assessed by one-way and/or multi-way 
sensitivity analysis. For example, ICERs may be sensitive to wage rates of key personnel and the overhead 
rates. Statistical uncertainty in the cost-effectiveness ratios will be assessed with 1,000 bootstrap samples. The 
outcome of each bootstrap sample will be expressed as a point on a scatter plot of incremental costs and 
percent screened and reflects the uncertainty arising from the model parameters. Scatter plots of the 
incremental costs and effects will be used to define the 95% confidence limits around the cost-effectiveness 
ratios.(146) 
Aim 3: Interaction analysis. 

 
 
Version date 1.24.2014   IRB Protocol #1009001808 
 
Hypothesis 1 Interactions: We will use interaction terms in the logistic regression models, developed above 
for analyses of Aim 1, to test whether intervention effects depend on knowledge, cancer screening beliefs, 
health status, demographic variables (age, race, education, and marital status), screening history, out-of-
pocket costs for screening, baseline stage of adoption, provider recommendation, and participant involvement 
in the intervention. We will also test the interaction between each intervention and whether participants sought 
help through additional contact(s) with the research assistants. If an interaction is significant, we will use 
parameter estimates from the logistic regression model to estimate odds ratios for intervention effects at various 
levels or scores of the interacting covariates (e.g., within each race or site, or at various values, for example 
quartiles, of perceived barriers). Because many interactions will be tested, we will adjust for multiple 
comparisons (see below). 
 
Hypothesis 2 Site Differences: We will compare screening adherence between the group of women who 
receive care in sites that have colonoscopy available with those who are not in such sites using logistic 
regression after adjusting for randomized group (usual care, TIWeb, CSC, and TIWeb + CSC).  
Adjustment for multiple comparisons: Because many tests will be performed in Exploratory Aim 3, we will 
report p-values adjusted for multiple comparisons in the analyses, using the resampling step-down adjustment 
method of Westfall and Young,(147) which accounts for the dependence structure between related tests.  
Analysis Issues: SPSS Data Entry(148) will be used as the data management system for the project’s 
telephone interviews. A computer-assisted telephone interview (CATI) program will be developed by an 
experienced programmer from the Indiana University School of Medicine Division of Biostatistics. For each 
field of entry, ranges will be set to accept only legitimate responses, and skip patterns will be programmed to 
make the interviews more accurate.  
Limitations of This Study and Analyses to Address Limitations: The proposed study is designed to 
achieve the specific aims and test the hypotheses. However, several limitations are listed below along with 
explanations of our efforts to minimize the limitations. 
• Loss to follow-up: Although we will attempt to retain subjects who complete the baseline telephone interview 
through the 6-month follow-up interview, there will be attrition because of participant dropout, death, and moving. 
We are conservatively estimating a 10% loss to follow-up although we expect it to be closer to our previous 
studies of 5% over a 6-month period. When analyses are performed to examine criterion variables at any given 
time point, all subjects who have data at that point will be included, minimizing the effects of loss of subjects 
because of later drop-out. In addition, the primary outcome variables, mammography and CRC cancer screening 
adherence, will be available through electronic records audit. As long as women drop out at a similar rate in both 
intervention groups, the threat to internal validity of dropout bias will be minimal (in addition, see Missing Data 
below). Additionally, we expect a low drop-out rate. It should be noted that attrition was accounted for in the 
sample size determination and power analysis. 
 
• Missing data and methods for handling in analyses: Missing data should be minimized by the use of 
telephone data collection and through interviewer training. Based on our previous work, we expect no more 
than 1-2% missing data for any single variable. Missing data for the major variables of CRC and breast 
cancer screening adherence (claims data) will be of concern if a woman changes health insurance plans. If a 
woman changes plans, we will still collect 6-month self-report data and inquire as to whether she has 
received either CRC or BC screening at another location. Because enrolled women will have signed informed 
consent to access claims data, we will be able to obtain CRC screening mammography records even in the 
event that health care plans have changed. We will examine reasons for drop-out and compare baseline 
characteristics of those with complete data versus those with missing data. If data are ‘missing at random’ 
(MAR) estimates will be biased and if ‘missing completely at random’ (MCAR) estimates will be inefficient if 
models are not adjusted for missingness. Therefore, we will use multiple imputation to perform adjustment for 
missingness. We will also perform sensitivity analyses to see how the results might have been affected under 
various assumptions had the data been available. The sensitivity analysis will also include estimating models 
while stratifying on the categories of missing data patterns,(149) although the multiple imputation method will 
be considered the more authoritative adjustment. Because patients will be randomized after they receive 
their baseline assessment, there are three possible missing data patterns (i.e., missing 2-week assessment, 
missing 6-month assessment, or missing both 2-week and 6-month). Furthermore, claims data will make it 

 
 
Version date 1.24.2014   IRB Protocol #1009001808 
 
possible to analyze adherence at 6 months even for women who dropped out, as long as claims data for 
those women can be obtained. 
• Sample bias: We conservatively estimate that about 50% of contacted women will consent to participate, 
and women who are interested in CRC or BC screening may self-select into the study. Contacting only 
nonadherent women will minimize this bias. 
• Feasibility/Clinical Relevance: Either of the intervention strategies tested in the proposed project could 
 easily be adapted into routine practice, if found effective. Previous studies have tailored interventions on a 
 large number of variables necessitating lengthy interviews (Preliminary Studies). In contrast, the proposed 
 interventions will be tailored on fewer variables and in an interactive format, thus facilitating data collection at 
 baseline and “batch processing” the intervention. The TIWeb could even be distributed during routine    care
 visits if a recent mammogram or CRC screening is not recorded on the chart. The addition of a CSC call from 
the provider’s office could also be incorporated into practice if found to  have an additive value to the TIWeb. 
E. Human Subjects 
1. Risks to Subjects 
 
Human Subjects Involvement and Characteristics. Participants in this study will be eligible if they have 
ever been a patient of any of the participating physicians; are age 50 to 75; are nonadherent to CRC or 
CRC and BC screening; and are able to complete telephone surveys and, depending on intervention, view 
a TIWeb, view a TIWeb and receive a counseling call, or receive usual care. Women will not be eligible if 
they have a history of adenomatous polyps, a personal history of CRC, inflammatory bowel disease of an 
hereditary syndrome (HNPCC\FAP), Eligibility criteria will be determined from both database records and 
self-report. Because this project involves mammography utilization, only women will be included. 
 
Source of Materials: Data will be obtained from self-report at baseline and at 4-week and 6-month follow-
up. Mammography status and CRC screening will be obtained from medical record data as well as self-
report. Cost data will be obtained from the study administrative records. 
 
Potential Risks: The proposed investigation does not present physical risk. Emotional or psychological 
risks, if they occur, would be slight. Possible fear or anxiety may be elicited when asking questions about 
BC,mammography, and/or colon cancer screening. 
2. Adequacy of Protection against Risks 
 Recruitment and Informed Consent: Recruitment of subjects follows a plan that complies with the HIPAA 
requirements. Eligible women will be identified by the INPC, Community Health Network, any of the 
participating physicians, or their designee.  The research office will send each potentially eligible woman a 
letter explaining the study and including a brochure and refusal postcard. Women will also receive a refusal 
postcard to send back if they choose not to be contacted.  They can also refuse by calling a toll free number or 
emailing the project manager (this information found on the brochure).  They can also call the toll-free 
telephone number provided on the brochure to call should they have questions. If women have not returned 
the refusal postcard, called, or emailed to decline within two weeks, they will be put on the schedule for a 
recruitment call. In order to tell whether or not the two week opt out period is sufficient time for women to opt 
out, the PI and project manager will monitor a spreadsheet that will be developed for tracking calls made by 
study staff to women who indicate that they did opt out of the study by returning the refusal postcard, calling 
the toll free number, or emailing the project manager.  If a woman indicates that she did opt out the study staff 
will apologize and indicate to the project manager or PI that this has happened.  The project manager will then 
make sure her documentation is destroyed.  Once this occurrence has happened a total of ten times, the PI will 
reevaluate the opt out time period and consider revising.  Any occurrences will be reported to the IRB at 
continuing review.   Research assistants will attempt to contact each woman by phone to further explain the 
study. If a woman indicates that she does not want to participate, she will be thanked for her time and no 
further contact will be made. If a woman agrees to participate, we will obtain verbal consent for a baseline 
telephone or electronic interview that will be conducted at the time of contact if convenient or within one week. 
The components of consent are listed on the brochure and include the right to terminate the study at any time 
without changes in health care. An authorization form to access medical records will be available for the 

 
 
Version date 1.24.2014   IRB Protocol #1009001808 
 
participant to sign electronically. The entire process of the study will be explained including the possibility of 
being assigned to one of two groups, the 4-week and 6-month telephone interviews, and the need to obtain 
mammography records.  
 
Protection against Risk: Interviewers and research assistants delivering the CSD will be graduate 
research assistants in a health-related field who will be trained to detect unwarranted anxiety or fear. 
Precautions will be taken to minimize anxiety, fear, and embarrassment. Women will be informed about the 
study prior to entry. Women will understand that they may terminate participation in this study at any time 
during the interview. They will also have the opportunity to decline to answer questions that are 
objectionable to them.  
The proposed research may present possible risk to confidentiality because follow-up interviews require 
monitoring of the participant’s address and telephone number. Participants will be given an identification code 
to separate identifying information from responses. Personnel involved with the interviewing will be educated 
about the importance of confidentiality. All identifying information will be destroyed following the final 
interview. Analyses will include only summaries of data and datasets with personal identifiers removed. 
The proposed research does involve slight emotional or psychological risk. Precautions will be taken to 
minimize these risks through: 1) thoroughly explaining the study initially, 2) emphasizing that participation is 
voluntary, 3) allowing the participant to stop at any time during the interview, 4) using well-trained female 
interviewers and nurse counselors, and 5) coding data for confidentiality. 
Indiana University has procedures in place to fulfill the NIH requirement for education in the Protection of 
Human Research Subjects. All grant personnel involved in the design or conduct of research involving 
human subjects on this project have or will complete this required education prior to the initiation of this 
project. 
3. Potential Benefits of the Proposed Research to Subjects and Others 
 
All participants will benefit monetarily because each will receive $60 in gift cards for fully completing the 
study ($20 for baseline and each of two telephone or electronic data collection interviews). In addition, 
participants may benefit from gaining knowledge about CRC and mammography screening.  We will utilize 
the gift card service offered by Hallmark Business Connections. 
4. Importance of knowledge to be gained: The research will indirectly benefit all women by testing 
interventions that may be related to BC and CRC screening behaviors in the population at greatest risk for 
CRC and BC, those 50 or older. Study findings may be used by health professionals to deliver new, more 
effective interventions to increase both CRC and BC screening. 
Women and Minority Inclusion in Clinical Research: 
By virtue of the nature of this study, all study participants will be women. Women will be recruited through  their 
physician’s medical records. Of these we estimate we will need to contact 5232 to yield 2616 participants who 
will be randomized, after consent, to one of three intervention groups and a usual care group. A letter of 
support is included in this application. 
Inclusion of Children 
The research topic to be studied is not relevant to children. 
Data Safety and Monitoring Plan 
Graduate research assistants will be extensively trained and monitored throughout the project to conduct 
computer-assisted telephone interventions (interviewers) and deliver assistance with the group completing the 
TIWeb program. Initial training will be conducted during a two-day session. The first day will consist of 
presentations including the following: 1) overview of grant objectives and rationale; 2) detailed demonstration 
of two intervention arms; 3) background and training on collecting data free from bias; 4) basic information on 
scale and item response issues; 5) protection of human subjects and confidentiality issues; and 6) data and 
intervention monitoring and quality assurance procedures. The second day will begin with a demonstration of 

 
 
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data collection using computer-assisted telephone interviewing. Following this initial demonstration, 
interviewers will role-play with videotaped feedback until they have reached 100% compliance with guidelines 
for data collection integrity. Research assistants who provide technical assistance to women needing help to 
use the TIWeb in their homes will be trained to assist with use of the TIWeb without providing additional 
education or information. They will practice and role-play until they have reached 100% compliance with 
guidelines for intervention delivery.  
Quality Assurance for Intervention Delivery 
Quality assurance and monitoring for integrity of intervention delivery are described in the previous section and 
in the Process Evaluation section of the proposal. Procedures for monitoring outcome data collection are 
described below. Dr. Susan Rawl will be responsible for oversight of monitoring quality assurance for 
intervention delivery, outcome data collection, and technical support. 
Quality Assurance for Outcome Data Collection 
After data collection begins, data collectors/interviewers will be part of the biweekly research team meetings 
that include the investigators, project managers, and research assistants to discuss project implementation and 
address questions or concerns that have arisen in the previous two weeks. All interviewers will be required to 
record one telephone interview each month; these interviews will be reviewed by the project manager and the 
investigators for quality assurance purposes. An evaluation checklist has been developed to assess the quality 
of data collection interviews and adherence to study protocol. Interviewers will be trained to query participants 
who have reported an abnormal mammogram to ensure prompt medical follow-up.  
Quality Assurance for Data Managers 
Data management will be handled by biostatisticians in the Indiana University, School of Medicine, Department 
of Medicine, Division of Biostatistics. Data monitoring will occur weekly as data from each interviewer are 
merged with the larger data set. Biostatisticians will handle all data merging. Backup data files will be kept in 
the Principal Investigator’s office as well as the office of the biostatisticians. Interviewers will complete a form 
each week when sending data to be merged. The form will alert the biostatisticians to any abnormalities in the 
data set. All computers that will be used to collect and send data during implementation of the study or to store 
data at the central secured location will be password-protected. 
Data integrity and security 
IUPUI-Clarian Institutional Review Board approvals and related documents as well as all signed informed 
consent forms will be kept at Indiana University, School of Nursing in a locked location. All computers will be 
password-protected. Only trained grant personnel will have access to data. Once all data have been linked 
together for individuals, identifiers will be deleted from the data base that includes interview and 
mammography data. Identifiers will be kept in separate locked files from the collected data and used only for 
follow-up data collection. At the end of the study all identifiers will be deleted. 
Identification of Adverse Effects 
The principal investigators will monitor adverse events. First, adverse events will be monitored through the 
interviewers. Any concern will be brought to the attention of the principal investigators and, if immediate action is 
necessary, it will be undertaken and later discussed at team meetings. Adverse events will also be immediately 
reported to the IUPUI-Clarian Institutional Review Board. Participants will have a phone number to call if 
problems occur. Indiana University has a process in place whereby random monitoring for data integrity will occur 
by a committee external to the grant staff. 
Data Sharing Plan 
Results of the trial will be disseminated through presentations at professional meetings and publications. The 
final dataset, with necessary identifiers (excluding those prohibited by HIPAA), will be made available to 
qualified investigators within 6 months of acceptance of the manuscript describing major outcomes. 
Investigators who request to use the dataset will be required to obtain IRB approval and sign a data use 
agreement before data will be released. 

 
 
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F.  Vertebrate Animals 
None 
 
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