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1.  Under-utilization of Lynch Syndrome Screening in a Multisite Study of Colorectal Cancer Patients 
To examine Lynch Syndrome (LS) screening of metastatic colorectal cancer (mCRC) patients in integrated healthcare delivery organizations.
We determined the availability of LS screening criteria and actual LS screening in the medical records among 1,188 patients diagnosed with mCRC between 2004–2009 at seven institutions in the Cancer Research Network (CRN).
We found infrequent use of LS screening (41/1188). Family history was available for 937 of the 1188 patients (79%). There was sufficient information to assess LS risk using family history based criteria in 719 of the 937 patients (77%) with family history documentation. In 391 individuals with a family history of a LS-associated cancer, 107 (27%) could not be evaluated due to missing information such as age of cancer onset. Eleven percent of patients who met Bethesda criteria and 25% of individuals who met the Amsterdam II criteria were screened for LS. When screening occurred, it followed recommended guidelines, but no testing method was preferred.
The information required for LS screening decisions is routinely collected but seldom utilized. There is a critical gap between collection of family history and its use to guide LS screening, which may support a case for implementation of universal screening guidelines.
PMCID: PMC3855589  PMID: 23639899
Lynch Syndrome; genetic testing; metastatic colorectal cancer; family history; hereditary cancer screening
2.  Patients’ and Family Members’ Views on Patient-Centered Communication During Cancer Care 
Psycho-oncology  2013;22(11):10.1002/pon.3317.
To explore patients’ and family members’ views on communication during cancer care, and to identify those aspects of clinician-patient communication which were most important to patients and family members.
We conducted a secondary data analysis of qualitative data from 137 patients with cancer and family members of patients with cancer. We used a modified version of the constant comparative method and coding paradigm of grounded theory.
Patients want sensitive, caring clinicians who provide information that they need, when they need it, in a way that they can understand; who listen and respond to questions and concerns, and who attempt to understand the patient’s experience. Effective information exchange and a positive interpersonal relationship with the clinician were of fundamental importance to patients and family members. These were interrelated; for instance, failure to provide information a patient needed could damage the relationship, while excellent listening could foster the relationship. Information exchange and relationship were also integral to decision making, managing uncertainty, responding to emotions, and self-management. Clinicians who were responsive to patients’ needs beyond the immediate medical encounter were valued.
The complexity of cancer care today suggest that efforts to improve communication must be multi-level, acknowledging and addressing patient, clinician, organizational and policy barriers and facilitators. Measurement tools are needed to assess cancer patients’ and family members’ experiences with communication over the course of cancer care in order to provide meaningful, actionable feedback to those seeking to optimize their effectiveness in communicating with patients with cancer.
PMCID: PMC3808529  PMID: 23780672
3.  Assessing Patient-Centered Communication in Cancer Care: Stakeholder Perspectives 
Journal of Oncology Practice  2013;9(5):e186-e193.
Patient reports of their communication experiences during cancer care could increase understanding of the communication process, stimulate improvements, inform interventions, and provide a basis for evaluating changes in communication practices.
Patient-centered communication is critical to quality cancer care. Effective communication can help patients and family members cope with cancer, make informed decisions, and effectively manage their care; suboptimal communication can contribute to care breakdowns and undermine clinician-patient relationships. The study purpose was to explore stakeholders' views on the feasibility and acceptability of collecting self-reported patient and family perceptions of communication experiences while receiving cancer care. The results were intended to inform the design, development, and implementation of a structured and generalizable patient-level reporting system.
This was a formative, qualitative study that used semistructured interviews with cancer patients, family members, clinicians, and leaders of health care organizations. The constant comparative method was used to identify major themes in the interview transcripts.
A total of 106 stakeholders were interviewed. Thematic saturation was achieved. All stakeholders recognized the importance of communication and endorsed efforts to improve communication during cancer care. Patients, clinicians, and leaders expressed concerns about the potential consequences of reports of suboptimal communication experiences, such as damage to the clinician-patient relationship, and the need for effective improvement strategies. Patients and family members would report good communication experiences in order to encourage such practices. Practical and logistic issues were identified.
Patient reports of their communication experiences during cancer care could increase understanding of the communication process, stimulate improvements, inform interventions, and provide a basis for evaluating changes in communication practices. This qualitative study provides a foundation for the design and pilot testing of such a patient reporting system.
PMCID: PMC3770509  PMID: 23943884
4.  Does KRAS Testing in Metastatic Colorectal Cancer Impact Overall Survival? A Comparative Effectiveness Study in a Population-Based Sample 
PLoS ONE  2014;9(5):e94977.
Epidermal growth factor receptor (EGFR) inhibitors are approved for treating metastatic colorectal cancer (CRC); KRAS mutation testing is recommended prior to treatment. We conducted a non-inferiority analysis to examine whether KRAS testing has impacted survival in CRC patients.
Patients and Methods
We included 1186 metastatic CRC cases from seven health plans. A cutpoint of July, 2008, was used to define two KRAS testing time period groups: “pre-testing” (n = 760 cases) and “post-testing” (n = 426 cases). Overall survival (OS) was estimated, and the difference in median OS between the groups was calculated. The lower bound of the one-sided 95% confidence interval (CI) for the difference in survival was used to test the null hypothesis of post-testing inferiority. Multivariable Cox regression models were constructed to adjust for covariates.
The median unadjusted OS was 15.4 months (95% CI: 14.0–17.5) and 12.8 months (95% CI: 10.0–15.2) in the pre- and post-testing groups, respectively. The OS difference was −2.6 months with one-sided 95% lower confidence bound of −5.13 months, which was less than the non-inferiority margin (−5.0 months, unadjusted p = 0.06), leading to a failure to reject inferiority of OS in the post-testing period. In contrast, in the adjusted analysis, OS non-inferiority was identified in the post-testing period (p = 0.001). Sensitivity analyses using cutpoints before and after July, 2008, also met the criteria for non-inferiority.
Implementation of KRAS testing did not influence CRC OS. Our data support the use of KRAS testing to guide administration of EGFR inhibitors for treatment of metastatic CRC without diminished OS.
PMCID: PMC4006772  PMID: 24788807
5.  Evaluation of a web-based asthma management intervention program for urban teenagers: Reaching the hard to reach 
Asthma interventions targeting urban adolescents are rare, despite a great need. Motivating adolescents to achieve better self-management of asthma is challenging, and the literature suggests that certain subgroups are more resistant than others. We conducted a school-based, randomized controlled trial to evaluate Puff City, a web-based, tailored asthma intervention, which included a referral coordinator, and incorporated theory-based strategies to target urban teens with characteristics previously found to be associated with lack of behavior change.
To identify eligible teens, questionnaires on asthma diagnoses and symptoms were administered to 9–12th graders of participating schools during a scheduled English class. Eligible, consenting students were randomized to Puff City (treatment) or generic asthma education (control).
422 students were randomized (98% African-American, mean age=15.6 years). At 12 month follow-up, adjusted Odds Ratios (95% Confidence Intervals) indicated intervention benefit for treatment teens for symptom-days and restricted activity days (analyzed as categorical variables) aOR=0.49 (0.24–0.79), p=0.006 and 0.53 (0.32–0.86), p=0.010, respectively. Among teens meeting baseline criteria for rebelliousness, treatment teens reported fewer symptom-days, symptom-nights, school absences and restricted activity days, aOR=0.30 (0.11–0.80), 0.29 (0.14–0.64), 0.40 (0.20–0.78), and 0.23 (0.10–0.55); all p<0.05. Among teens reporting low perceived emotional support, treatment students reported only fewer symptom-days than controls, aOR=0.23 (0.06 – 0.88), p=0.031. Statistically significant differences in medical care use were not observed.
Results suggest a theory-based, tailored approach, with a referral coordinator, can improve asthma management in urban teens. Puff City represents a viable strategy for disseminating an effective intervention to high risk and hard-to-reach populations.
PMCID: PMC3632347  PMID: 23299008
6.  KRAS Testing and Epidermal Growth Factor Receptor Inhibitor Treatment for Colorectal Cancer in Community Settings 
In metastatic colorectal cancer (mCRC), mutations in the KRAS gene predict poor response to epidermal growth factor receptor (EGFR) inhibitors. Clinical treatment guidelines now recommend KRAS testing if EGFR inhibitors are considered. Our study investigates the clinical uptake and utilization of KRAS testing.
We included 1,188 patients with mCRC diagnosed from 2004 to 2009, from seven integrated health care delivery systems with a combined membership of 5.5 million. We used electronic medical records and targeted manual chart review to capture the complexity and breadth of real-world clinical oncology care.
Overall, 428 patients (36%) received KRAS testing during their clinical care, and 266 (22%) were treated with EGFR inhibitors. Age at diagnosis (p=0.0034), comorbid conditions (p=0.0316), and survival time from diagnosis (p<0.0001) influence KRAS testing and EGFR inhibitor prescribing. The proportion who received KRAS testing increased from 7% to 97% for those treated in 2006 and 2010, respectively, and 83% of all treated patients had a KRAS wild type genotype. Most patients with a KRAS mutation (86%) were not treated with EGFR inhibitors. The interval between mCRC diagnosis and receipt of KRAS testing decreased from 26 months (2006) to 10 months (2009).
These findings demonstrate rapid uptake and incorporation of this predictive biomarker into clinical oncology care.
In this delivery setting, KRAS testing is widely used to guide treatment decisions with EGFR inhibitors in patients with mCRC. An important future research goal is to evaluate utilization of KRAS testing in other delivery settings in the US.
PMCID: PMC3567775  PMID: 23155138
biomarker; utilization; colorectal neoplasms; managed care programs
7.  Oncologists' attitudes toward KRAS testing: a multisite study 
Cancer Medicine  2013;2(6):881-888.
Recent discoveries promise increasingly to help oncologists individually tailor anticancer therapy to their patients’ molecular tumor characteristics. One such promising molecular diagnostic is Kirsten ras (KRAS) tumor mutation testing for metastatic colorectal cancer (mCRC) patients. In the current study, we examined how and why physicians adopt KRAS testing and how they subsequently utilize the information when discussing treatment strategies with patients. We conducted 34 semi-structured in-person or telephone interviews with oncologists from seven different health plans. Each interview was audiotaped, transcribed, and coded using qualitative research methods. Information and salient themes relating to the research questions were summarized for each interview. All of the oncologists in this study reported using the KRAS test at the time of the interview. Most appeared to have adopted the test rapidly, within 6 months of the publication of National Clinical Guidelines. Oncologists chose to administer the test at various time points, although the majority ordered the test at the time their patient was diagnosed with mCRC. While oncologists expressed a range of opinions about the KRAS test, there was a general consensus that the test was useful and provided benefits to mCRC patients. The rapid adoption and enthusiasm for KRAS suggests that these types of tests may be filling an important informational need for oncologists when making treatment decisions. Future research should focus on the informational needs of patients around this test and whether patients feel informed or confident with their physicians’ use of these tests to determine treatment access.
PMCID: PMC3892392  PMID: 24403261
Cancer genetics; colorectal cancer; psychosocial studies
8.  Skin Cancer Education for Primary Care Physicians: A Systematic Review of Published Evaluated Interventions 
Journal of General Internal Medicine  2011;26(9):1027-1035.
Early detection of melanoma may provide an opportunity to positively impact melanoma mortality. Numerous skin cancer educational interventions have been developed for primary care physicians (PCPs) to improve diagnostic accuracy. Standardized training is also a prerequisite for formal testing of melanoma screening in the primary care setting.
We conducted a systematic review to determine the extent of evaluated interventions designed to educate PCPs about skin cancer, including melanoma.
Relevant studies in the English language were identified through systemic searches performed in MEDLINE, EMBASE, BIOSIS, and Cochrane through December 2010. Supplementary information was obtained from corresponding authors of the included studies when necessary.
Studies eligible for inclusion formally evaluated skin cancer education interventions and were designed primarily for PCPs. Excluded studies lacked a specified training intervention, used decision-making software, focused solely on risk factor identification, or did not directly educate or assess participants. Twenty studies met the selection criteria. Data were extracted according to intervention content and delivery format, and study outcomes.
All interventions included instructions about skin cancer diagnosis, but otherwise varied in content. Curricula utilized six distinct educational techniques, usually incorporating more than one. Intervention duration varied from 12 min to over 6 h. Eight of the 20 studies were randomized trials. Most studies (18/20, 90%) found a significant improvement in at least one of the following five outcome categories: knowledge, competence, confidence, diagnostic performance, or systems outcomes. Competence was most commonly measured; no study evaluated all categories. Variability in study design, interventions, and outcome measures prevented correlation of outcomes with intervention characteristics.
Despite the development of many isolated educational interventions, few have been tested rigorously or evaluated under sufficient standardized conditions to allow for quantitative comparison. Improved and rigorously tested skin cancer educational interventions for PCPs with outcome measures focusing on changes in performance are needed.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-011-1692-y) contains supplementary material, which is available to authorized users.
PMCID: PMC3157536  PMID: 21472502
primary care; medical education; melanoma; skin cancer
Health Psychology  2009;28(4):394-403.
Many targeted health interventions have been developed and tested with African American (AA) populations; however, AAs are a highly heterogeneous group. One characteristic that varies across AAs is Ethnic Identity (EI). Despite the recognition that AAs are heterogeneous with regard to EI, little research has been conducted on how to incorporate EI into the design of health messages and programs.
This randomized trial tested whether tailoring a print-based fruit and vegetable (F & V) intervention based on individual EI would enhance program impact beyond that of social cognitive tailoring alone. AA adults were recruited from two integrated healthcare delivery systems, one based in the Detroit Metro area and the other in the Atlanta Metro area, and then randomized to receive three newsletters focused on F & V behavior change over three months. One set of newsletters was tailored only on demographic, behavioral, and social cognitive variables (control condition) whereas the other (experimental condition) was additionally tailored on EI.
Main Outcome Measures
The primary outcome for the study was F & V intake, which was assessed at baseline and three months later using the composite of two brief self-report frequency measures.
A total of 560 eligible participants were enrolled, of which 468 provided complete 3-month follow-up data. The experimental group increased their daily mean F & V intake by 1.1 servings compared to .8 servings in the control group (p = .13). Several variables were found to interact with intervention group. For instance, Afrocentric experimental group participants showed a 1.4 increase in F & V servings per day compared to a .43 servings per day increase among Afrocentric controls (p < .05).
Although the overall between-group effects were not significant, this study confirms that AAs are a highly diverse population and that tailoring dietary messages on ethnic identity may improve intervention impact for some AA subgroups.
PMCID: PMC3397196  PMID: 19594262
10.  Ethnic Identity Predicts Loss-to-follow-up in a Health Promotion Trial 
Contemporary clinical trials  2010;31(5):414-418.
Higher rates of attrition in health research have been reported for African Americans (AAs). However, little is known about which AAs are more prone to drop out and why. One potential predictor that has not been explored is Ethnic Identity (EI). This study examined the association between EI and loss-to-follow-up among AAs enrolled in a health promotion intervention to increase fruit and vegetable intake.
Five hundred and sixty AA adults from two integrated health care delivery systems in Atlanta and Detroit were enrolled into a randomized intervention trial. At baseline, all participants were classified into six EI core groups: Afrocentric, Black American, Bicultural, Multicultural, Assimilated, and High Cultural Mistrust. We examined loss-to-follow-up rates by these EI type.
Overall, 92 participants (16%) were lost to follow up. Loss-to-follow-up rates were higher among those classified as Afrocentric (24%) than those without an Afrocentric identity (13%). After adjustment for covariates, Afrocentric participants were 1.9 times (CI: 1.1 – 3.6) more likely to be lost to follow up than participants without this identity type.
Assessing EI of AAs in research studies may help identify groups at risk for dropout and/or non-response.
PMCID: PMC3117283  PMID: 20601162
Ethnic identity; African American; tailored health communication
11.  A New Audience Segmentation Tool for African Americans: The Black Identity Classification Scale 
Journal of health communication  2010;15(5):532-554.
Many health communications target African Americans in an attempt to remediate race-based health disparities. Such materials often assume that African Americans are culturally homogeneous; however, research indicates that African Americans are heterogeneous in their attitudes, behaviors, and beliefs. The Black Identity Classification Scale (BICS) was designed as a telephone-administered tool to segment African American audiences into 16 ethnic identity types. The BICS was pretested using focus groups, telephone pretests, and a pilot study (n=306). The final scale was then administered to 625 Black adults participating in a dietary intervention study, where it generally demonstrated good internal consistency reliability. The construct validity of the BICS was also explored by comparing participants’ responses to culturally associated survey items. The distribution of the 16 BICS identity types in the intervention study is presented, as well as select characteristics for participants with core identity components. Although additional research is warranted, these findings suggest that the BICS has good psychometric properties and may be an effective tool for identifying African American audience segments.
PMCID: PMC3151736  PMID: 20677057
12.  Comparison of early-, late-, and non-participants in a school-based asthma management program for urban high school students 
Trials  2011;12:141.
To assess bias and generalizability of results in randomized controlled trials (RCT), investigators compare participants to non-participants or early- to late-participants. Comparisons can also inform the recruitment approach, especially when working with challenging populations, such as urban adolescents. In this paper, we describe characteristics by participant status of urban teens eligible to participate in a RCT of a school-based, web-based asthma management program.
The denominator for this analysis was all students found to be eligible to participate in the RCT. Data were analyzed for participants and non-participants of the RCT, as well as for students that enrolled during the initially scheduled recruitment period (early-participants) and persons that delayed enrollment until the following fall when recruitment was re-opened to increase sample size (late-participants). Full Time Equivalents (FTEs) of staff associated with recruitment were estimated.
Of 1668 teens eligible for the RCT, 386 enrolled early, and 36 enrolled late, leaving 1246 non-participants. Participants were younger (p < 0.01), more likely to be diagnosed, use asthma medication, and have moderate-to-severe disease than non-participants, odds ratios (95% Confidence Intervals) = 2.1(1.7-2.8), 1.7(1.3-2.1), 1.4(1.0-1.8), respectively. ORs were elevated for the association of late-participation with Medicaid enrollment, 1.9(0.7-5.1) and extrinsic motivation to enroll, 1.7(0.6-5.0). Late-participation was inversely related to study compliance for teens and caregivers, ORs ranging from 0.1 to 0.3 (all p-values < 0.01). Early- and late-participants required 0.45 FTEs/100 and 3.3 FTEs/100, respectively.
Recruitment messages attracted youth with moderate-to-severe asthma, but extending enrollment was costly, resulting in potentially less motivated, and certainly less compliant, participants. Investigators must balance internal versus external validity in the decision to extend recruitment. Gains in sample size and external validity may be offset by the cost of additional staff time and the threat to internal validity caused by lower participant follow-up.
Trial Registration NCT00201058
PMCID: PMC3126736  PMID: 21645394
13.  A Randomized Clinical Trial Evaluating Online Interventions to Improve Fruit and Vegetable Consumption 
American journal of public health  2009;100(2):319-326.
We assessed change in fruit and vegetable intake in a population-based sample, comparing an online untailored program (arm 1) with a tailored behavioral intervention (arm 2) and with a tailored behavioral intervention plus motivational interviewing–based counseling via e-mail (arm 3).
We conducted a randomized controlled intervention trial, enrolling members aged 21 to 65 years from 5 health plans in Seattle, Washington; Denver, Colorado; Minneapolis, Minnesota; Detroit, Michigan; and Atlanta, Georgia. Participants reported fruit and vegetable intake at baseline and at 3, 6, and 12 months. We assessed mean change in fruit and vegetable servings per day at 12 months after baseline, using a validated self-report fruit and vegetable food frequency questionnaire.
Of 2540 trial participants, 80% were followed up at 12 months. Overall baseline mean fruit and vegetable intake was 4.4 servings per day. Average servings increased by more than 2 servings across all study arms (P<.001), with the greatest increase (+2.8 servings) among participants of arm 3 (P=.05, compared with control). Overall program satisfaction was high.
This online nutritional intervention was well received, convenient, easy to disseminate, and associated with sustained dietary change. Such programs have promise as population-based dietary interventions.
PMCID: PMC2804654  PMID: 20019315
14.  Engagement and Retention: Measuring Breadth and Depth of Participant Use of an Online Intervention 
The Internet provides us with tools (user metrics or paradata) to evaluate how users interact with online interventions. Analysis of these paradata can lead to design improvements.
The objective was to explore the qualities of online participant engagement in an online intervention. We analyzed the paradata in a randomized controlled trial of alternative versions of an online intervention designed to promote consumption of fruit and vegetables.
Volunteers were randomized to 1 of 3 study arms involving several online sessions. We created 2 indirect measures of breadth and depth to measure different dimensions and dynamics of program engagement based on factor analysis of paradata measures of Web pages visited and time spent online with the intervention materials. Multiple regression was used to assess influence of engagement on retention and change in dietary intake.
Baseline surveys were completed by 2513 enrolled participants. Of these, 86.3% (n = 2168) completed the follow-up surveys at 3 months, 79.6% (n = 2027) at 6 months, and 79.4% (n = 1995) at 12 months. The 2 tailored intervention arms exhibited significantly more engagement than the untailored arm (P < .01). Breadth and depth measures of engagement were significantly associated with completion of follow-up surveys (odds ratios [OR] = 4.11 and 2.12, respectively, both P values < .001). The breadth measure of engagement was also significantly positively associated with a key study outcome, the mean increase in fruit and vegetable consumption (P < .001).
By exploring participants’ exposures to online interventions, paradata are valuable in explaining the effects of tailoring in increasing participant engagement in the intervention. Controlling for intervention arm, greater engagement is also associated with retention of participants and positive change in a key outcome of the intervention, dietary change. This paper demonstrates the utility of paradata capture and analysis for evaluating online health interventions.
Trial Registration
NCT00169312; (Archived by WebCite at
PMCID: PMC3056524  PMID: 21087922
Methodological studies; Internet; process metrics; tailored intervention
15.  Focus Groups Inform a Web-Based Program to Increase Fruit and Vegetable Intake 
Patient education and counseling  2009;77(2):314-318.
To use focus groups to inform a web-based educational intervention for increased fruit and vegetable (FV) consumption.
Twelve groups (participants =137, aged 21–65) were recruited from four geographically diverse health systems. Four groups were stratified by gender and eight by race (white and African American) and gender. Questions included perceptions of healthy eating, factors that encourage or serve as barriers to FV consumption and features preferred for a web-based educational intervention.
Though knowledgeable about healthy eating, participants did not know how to achieve or always care about healthy nutritional choices. Motivators for FV consumption included being role models and health concerns. Barriers included: lack of time, expense and FV availability. Website preferences included: visuals, links, tailored materials, menu suggestions, goal setting assistance, printable summaries and built in motivation. The developers incorporated nearly all suggestions.
Focus groups provided needs-based tactical strategies for an online, education intervention targeting factors to improve FV consumption.
Practice Implications
Focus groups can provide valuable input to inform interventions. Further, web-based programs’ abilities to offer information without time or geographic constraints, with capacity for tailoring and tracking progress makes them a valuable addition in the arsenal of efforts to promote healthy behaviors.
PMCID: PMC2767451  PMID: 19409750
Fruit and Vegetable Consumption; Patient education; Internet; Focus Groups; Web-based interventions; Health Maintenance Organization
16.  Challenges in Researching Racially Sensitive Topics in HMOs 
PMCID: PMC2735257  PMID: 19594260
HMO; health plans; health disparities; cultural sensitivity; ethnic identity; African American
17.  Cost analyses of a web-based behavioral intervention to enhance fruit and vegetable consumption 
The purpose of this paper is to evaluate costs associated with the online intervention trial, Making Effective Nutritional Choices for Cancer Prevention (MENU), and to connect the findings to the study outcomes.
Using prospective data collected during the MENU development and implementation phases, we estimated overall costs per person, incremental costs for the three arms of the MENU intervention, and incremental costs per change in fruit and vegetable (F&V) consumption across the studied population. The MENU study was conducted in five HMO sites of the Cancer Research Network. The number of eligible study participants who were enrolled in the study was 2,540. Recruited participants were randomized into (1) an untailored website program, (2) tailored website program, or (3) tailored web program plus personalized counseling (HOBI) via email. The primary measures for these analyses include the total intervention costs, average cost per participant, and the average cost per mean change in daily intake of F&V, stratified by study arm.
The mean change in F&V consumption was greater in both the tailored arm and statistically higher in the HOBI arm relative to the untailored arm. The untailored arm achieved +2.34 servings increase vs. the tailored website arm (+2.68) and the HOBI arm (+2.80) servings increase. Total intervention costs for MENU participants who completed the 12-month follow-up assessment, by study arm, were estimated to be $197,197 or $110 respectively. This translates to $69 per participant in the untailored web site intervention, $81 per participant in the tailored website intervention, and $184 per participant in the HOBI intervention and a cost per average change in F&V consumption to be $35, $27 and $61 respectively.
Providing personalized "tailored" messages and additional personalized support via email generated an additional $12-$115 per participant, over the untailored web program. Incremental increases in F&V consumption associated with the email support arm were associated with considerable increases in intervention costs, suggesting that the most cost effective arm of the MENU study by servings gained was the tailored website.
PMCID: PMC2807418  PMID: 20040096
18.  Recruitment to a Randomized Web-Based Nutritional Intervention Trial: Characteristics of Participants Compared to Non-Participants 
Web-based behavioral programs efficiently disseminate health information to a broad population, and online tailoring may increase their effectiveness. While the number of Internet-based behavioral interventions has grown in the last several years, additional information is needed to understand the characteristics of subjects who enroll in these interventions, relative to those subjects who are invited to enroll.
The aim of the study was to compare the characteristics of participants who enrolled in an online dietary intervention trial (MENU) with those who were invited but chose not to participate, in order to better understand how these groups differ.
The MENU trial was conducted among five health plans participating in the HMO Cancer Research Network in collaboration with the University of Michigan Center for Health Communication Research. Approximately 6000 health plan members per site, between the ages of 21 and 65, and stratified by gender with oversampling of minority populations, were randomly selected for recruitment and were mailed an invitation letter containing website information and a US$2 bill with the promise of US$20 for completing follow-up surveys. Administrative and area-based data using geocoding along with baseline survey data were used to compare invitees (HMO members sent the introductory letter), responders (those who entered a study ID on the website), and enrollees (those who completed the enrollment process). Generalized estimating equation multivariate and logistic regression models were used to assess predictors of response and enrollment.
Of 28,460 members invited to participate, 4270 (15.0%) accessed the website. Of the eligible responders, 2540 (8.9%) completed the consent form and baseline survey and were enrolled and randomized. The odds of responding were 10% lower for every decade of increased age (P < .001), while the likelihood of enrolling was 10% higher for every decade increase in age (P < .001). Women were more likely to respond and to enroll (P < .001). Those living in a census tract associated with higher education levels were more likely to respond and enroll, as well as those residing in tracts with higher income (P < .001). With a 22% (n = 566) enrollment rate for African Americans and 8% (n = 192) for Hispanics, the enrolled sample was more racially and ethnically diverse than the background sampling frame.
Relative to members invited to participate in the Internet-based intervention, those who enrolled were more likely to be older and live in census tracts associated with higher socioeconomic status. While oversampling of minority health plan members generated an enrolled sample that was more racially and ethnically diverse than the overall health plan population, additional research is needed to better understand methods that will expand the penetration of Internet interventions into more socioeconomically diverse populations.
Trial Registration NCT00169312; (Archived by WebCite at
PMCID: PMC2762858  PMID: 19709990
Recruitment; Web-based interventions; making effective nutritional choices; Cancer Research Network; CRN; fruits and vegetables; research subject selection; selection; patient; mass screening; Internet; motivation; cultural diversity; health maintenance organizations
19.  Web-Based Smoking-Cessation Program 
Initial trials of web-based smoking-cessation programs have generally been promising. The active components of these programs, however, are not well understood. This study aimed to (1) identify active psychosocial and communication components of a web-based smoking-cessation intervention and (2) examine the impact of increasing the tailoring depth on smoking cessation.
Randomized fractional factorial design.
Two HMOs: Group Health in Washington State and Henry Ford Health System in Michigan.
1866 smokers.
A web-based smoking-cessation program plus nicotine patch. Five components of the intervention were randomized using a fractional factorial design: high- versus low-depth tailored success story, outcome expectation, and efficacy expectation messages; high- versus low-personalized source; and multiple versus single exposure to the intervention components.
Primary outcome was 7 day point-prevalence abstinence at the 6-month follow-up.
Abstinence was most influenced by high-depth tailored success stories and a high-personalized message source. The cumulative assignment of the three tailoring depth factors also resulted in increasing the rates of 6-month cessation, demonstrating an effect of tailoring depth.
The study identified relevant components of smoking-cessation interventions that should be generalizable to other cessation interventions. The study also demonstrated the importance of higher-depth tailoring in smoking-cessation programs. Finally, the use of a novel fractional factorial design allowed efficient examination of the study aims. The rapidly changing interfaces, software, and capabilities of eHealth are likely to require such dynamic experimental approaches to intervention discovery.
PMCID: PMC2697448  PMID: 18407003
20.  Effect of Incentives and Mailing Features on Online Health Program Enrollment 
With the growing use of Internet-based interventions, strategies are needed to encourage broader participation. This study examined the effects of combinations of monetary incentives and mailing characteristics on enrollment, retention, and cost effectiveness for an online health program.
In 2004, a recruitment letter was mailed to randomly selected Midwestern integrated health system members aged 21–65 and stratified by gender and race/ethnicity; recipients were randomly pre-assigned to one of 24 combinations of incentives and various mailing characteristics. Enrollment and 3-month retention rates were measured by completion of online surveys. Analysis, completed in 2005, compared enrollment and retention factors using t tests and chi-square tests. Multivariate logistic regression modeling assessed the probability of enrollment and retention.
Of 12,289 subjects, 531 (4.3%) enrolled online, ranging from 1% to 11% by incentive combination. Highest enrollment occurred with unconditional incentives, and responses varied by gender. Retention rates ranged from 0% to 100%, with highest retention linked to higher-value incentives. The combination of a $2 bill prepaid incentive and the promise of $20 for retention (10% enrollment and 71% retention) was optimal, considering per-subject recruitment costs ($32 enrollment, $70 retention) and equivalent enrollment by gender and race/ethnicity.
Cash incentives improved enrollment in an online health program. Men and women responded differently to mailing characteristics and incentives. Including a small prepaid monetary incentive ($2 or $5) and revealing the higher promised-retention incentive was cost effective and boosted enrollment.
PMCID: PMC2442737  PMID: 18407004
21.  The Role of Engagement in a Tailored Web-Based Smoking Cessation Program: Randomized Controlled Trial 
Web-based programs for health promotion, disease prevention, and disease management often experience high rates of attrition. There are 3 questions which are particularly relevant to this issue. First, does engagement with program content predict long-term outcomes? Second, which users are most likely to drop out or disengage from the program? Third, do particular intervention strategies enhance engagement?
To determine: (1) whether engagement (defined by the number of Web sections opened) in a Web-based smoking cessation intervention predicts 6-month abstinence, (2) whether particular sociodemographic and psychographic groups are more likely to have lower engagement, and (3) whether particular components of a Web-based smoking cessation program influence engagement.
A randomized trial of 1866 smokers was used to examine the efficacy of 5 different treatment components of a Web-based smoking cessation intervention. The components were: high- versus low-personalized message source, high- versus low-tailored outcome expectation, efficacy expectation, and success story messages. Moreover, the timing of exposure to these sections was manipulated, with participants randomized to either a single unified Web program with all sections available at once, or sequential exposure to each section over a 5-week period of time. Participants from 2 large health plans enrolled to receive the online behavioral smoking cessation program and a free course of nicotine replacement therapy (patch). The program included: an introduction section, a section focusing on outcome expectations, 2 sections focusing on efficacy expectations, and a section with a narrative success story (5 sections altogether, each with multiple screens). Most of the analyses were conducted with a stratification of the 2 exposure types. Measures included: sociodemographic and psychosocial characteristics, Web sections opened, perceived message relevance, and smoking cessation 6-months following quit date.
The total number of Web sections opened was related to subsequent smoking cessation. Participants who were younger, were male, or had less formal education were more likely to disengage from the Web-based cessation program, particularly when the program sections were delivered sequentially over time. More personalized source and high-depth tailored self-efficacy components were related to a greater number of Web sections opened. A path analysis model suggested that the impact of high-depth message tailoring on engagement in the sequentially delivered Web program was mediated by perceived message relevance.
Results of this study suggest that one of the mechanisms underlying the impact of Web-based smoking cessation interventions is engagement with the program. The source of the message, the degree of message tailoring, and the timing of exposure appear to influence Web-based program engagement.
PMCID: PMC2630833  PMID: 18984557
Internet, World Wide Web; smoking cessation; engagement
22.  Interest in an Online Smoking Cessation Program and Effective Recruitment Strategies: Results From Project Quit 
The Internet is a promising venue for delivering smoking cessation treatment, either as a stand-alone program or as an adjunct to pharmacotherapy. However, there is little data to indicate what percent of smokers are interested in receiving online smoking cessation services or how best to recruit smokers to Internet-based programs.
Using a defined recruitment sample, this study aimed to identify the percentage of smokers who expressed interest in or enrolled in Project Quit, a tailored, online, cognitive-behavioral support program offered with adjunctive nicotine replacement therapy patches. In addition, we examined the effectiveness of several individual-level versus population-level recruitment strategies.
Members from two large health care organizations in the United States were invited to participate in Project Quit. Recruitment efforts included proactive invitation letters mailed to 34533 likely smokers and reactive population-level study advertisements targeted to all health plan members (> 560000 adults, including an estimated 98000 smokers across both health care organizations).
An estimated 1.6% and 2.5% of adult smokers from each health care organization enrolled in Project Quit. Among likely smokers who received proactive study invitations, 7% visited the Project Quit website (n = 2260) and 4% (n = 1273) were eligible and enrolled. Response rates were similar across sites, despite using different sources to assemble the invitation mailing list. Proactive individual-level recruitment was more effective than other forms of recruitment, accounting for 69% of website visitors and 68% of enrollees.
Smokers were interested in receiving online smoking cessation support, even though they had access to other forms of treatment through their health insurance. Uptake rates for this program were comparable to those seen when smokers are advised to quit and are referred to other forms of smoking cessation treatment. In this sample, proactive mailings were the best method for recruiting smokers to Project Quit.
PMCID: PMC2018826  PMID: 16954124
Internet; tobacco dependence; nicotine dependence; smoking cessation; recruitment activities

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