Laffin, Jennifer

Objective To identify the optimal incentive protocol for maximising participation while managing study costs during the Voyage trial. Design Prospective cohort (Voyage trial) of colorectal cancer (CRC) incidence and mortality outcomes in individuals screened with multitarget stool DNA (mt-sDNA) served as the population. A subset was randomised to receive postage stamps as a pre-consent incentive, or as a post-consent incentive after completion of the consent and questionnaire. Descriptive statistics from year 1 are reported. Results During year 1 of the Voyage trial, a total of 600 258 individuals with mt-sDNA orders received at Exact Sciences Laboratories were randomly selected and invited to participate. Of those, 26 429 (4.4%) opted in, 14 365 of whom (54.3%) consented. The opt-in and consent samples were similar to the target population with respect to sex but differed by geographic residence and age (p<0.001). For the embedded incentive experiment, 2333 were randomised to the pre-incentive arm, while 2342 were randomised to the post-incentive arm. Overall consent rate in the incentive trial was 56.4% (60.9% for the pre-consent incentive arm (1421/2333) vs 52.0% for the post-consent incentive arm (1217/2342), p<0.001). Cost reduction was observed for the pre-consent incentive group, and higher response rates were seen among older versus younger individuals. Conclusions Pre-consent incentive option was associated with a higher participation rate and lower costs and was used for the remainder of study recruitment. CRC incidence and mortality vary with age; thus, adjusting for differential participation by age and region will be important in analyses of Voyage data. Trial registration number NCT04124406.

Abstract Background: Adherence to recommended colorectal cancer (CRC) screening among US adults is below the public health target of 80%. The multi-target stool DNA assay (mt-sDNA) is a self-administered CRC screening test that may remove barriers to adherence. To improve understanding of long-term outcomes and the real-world impact of mt-sDNA screening, Mayo Clinic and Exact Sciences Laboratories are collaborating on a prospective cohort study of CRC incidence and mortality outcomes in individuals screened with mt-sDNA. We conducted an embedded experiment to identify the optimal incentive protocol for maximizing participation while managing study costs. Methods: A subset of the opt-in cohort was randomized to receive postage stamps as a pre-consent incentive, or as a post-consent incentive after completion of the consent and questionnaire. Descriptive statistics from year one of recruitment, as well as the incentive experiment, are reported. Results: During year 1 of the Voyage trial, a total of 600,258 individuals with mt-sDNA orders received at Exact Sciences Laboratories were randomly selected and invited to participate. Of those, 26,429 (4.4%) opted in, 14,365 of whom (54.3%) consented. The opt-in and consent samples were similar to the target population with respect to sex but differed by geographic residence and age (p<0.001). For the embedded incentive experiment, 2,333 were randomized to the pre-incentive arm while 2,342 were randomized to the post-incentive arm. Overall consent rate in the incentive trial was 56.4% (60.9% for the pre-consent incentive arm (1421/2333) vs. 52.0% for the post-consent incentive arm (1217/2432), p<0.001). A cost reduction was observed for the pre-consent incentive group. Higher response rates were seen among older vs. younger individuals, reflecting a common pattern in healthcare-related survey research participation. Age adjusted incidence rates for CRC have been shown to vary regionally; thus, adjustment for differential response by region will be important to ensure representativeness. Conclusions: CRC incidence and mortality vary with age; thus, adjusting for differential participation by age will be important in analyses of Voyage data. Pre-consent incentive option was associated with a higher participation rate and lower costs, and will be used for the remainder of the study recruitment. Trial Registration: NCT04124406; October 11th, 2019

Abstract Background: Multiple guideline-recommended colorectal cancer (CRC) screening options have been shown to reduce CRC incidence and mortality among average-risk patients. Yet, CRC screening continues to be underutilized in the US. Provider recommendation has consistently shown to improve screening completion. Our study aimed to delineate the pathways through which provider communication influences CRC screening completion. We tested how provider communication about the "Why” and “How” of mt-sDNA screening contributes to mt-sDNA screening intention through influencing patients’ screening outcome expectancies and perceived behavioral control. Methods: Data came from a behavioral theory-informed survey that we developed to identify psychosocial factors associated with mt-sDNA screening. The survey was administered between 3/22-6/22 by RTI International, with a sample of US adults ages 45-75 who received a valid order for mt-sDNA screening with a shipping date between 5/21-9/21. Participants completed an electronic or paper survey. We measured patients’ reports of providers’ “Why” communication with items on mt-sDNA screening performance, advantages/disadvantages, and cost. Providers’ “How” communication was measured with items on instructions and need for follow-up testing. We tested the proposed relationships using structural equation modeling and tested indirect effects using bootstrapping. Results: A total of 2973 participants completed the survey (response rate: 21.7%). “Why” communication was positively associated with perceived effectiveness of mt-sDNA screening (b = 0.349, p &lt; .001) and negatively associated with CRC worry (b = -0.078, p = .002). “How” communication was positively associated with perceived ease of use (b = 0.392, p &lt; .001) and perceived comfort of mt-sDNA screening (b = 0.138, p &lt; .001). Perceived effectiveness and perceived ease of use were positively associated with intention to complete mt-sDNA screening (b = 0.404, p &lt; .001; b = 0.339, p &lt; .001). “Why” communication contributed to screening intention through influencing perceived effectiveness (b-indirect effect = 0.141, 95% CI: 0.115, 0.177). “How” communication contributed to screening intention through influencing perceived ease of use (b-indirect effect = 0.133, 95% CI: 0.104, 0.172). Conclusions: Improving patients’ beliefs about the effectiveness and ease of use of screening may be one pathway through which provider communication contributes to CRC screening completion. Efforts are needed to develop and implement provider-patient communication strategies and toolkits that are efficacious at fostering patient understanding of the rationale for CRC screening and the effectiveness of available screening options as well as addressing barriers and enhancing patients’ self-efficacy in completing their preferred screening option. Citation Format: Xuan Zhu, Paul Limburg, Linda Squiers, Leah Helmueller, Gabriel Madson, Brian Southwell, Carlye Gates, Shama Alam, Jennifer Laffin, Lila Finney Rutten. Provider communication contributes to colorectal cancer screening intention through improving screening outcome expectancies and perceived behavioral control [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 770.

Introduction Population-level screening has been shown to reduce the incidence and mortality of colorectal cancer (CRC). Unfortunately, adherence to screening recommendations among eligible US adults remains below national goals. A relatively new non-invasive screening modality, the Food and Drug Administration–approved multi-target stool DNA (mt-sDNA) assay (commercialised as Cologuard), which combines the detection of haemoglobin and DNA abnormalities, has been completed by more than 3 million individuals. Given mt-sDNA’s recent availability, the effectiveness of mt-sDNA screening with respect to CRC incidence and mortality reduction has not yet been established. Methods and analysis Through an academic–industry collaboration, a prospective cohort study (Voyage) was designed with an initial enrolment target of 150 000 individuals with mt-sDNA ordered by their healthcare provider for CRC screening. Consented participants will be asked to complete a baseline questionnaire to collect sociodemographic and health information. Additional questionnaires will be provided after 1 year, and every 3 years thereafter, to collect data regarding CRC screening follow-up in order to estimate rates of CRC incidence and other health outcomes. Linkage to the National Death Index will be used to estimate mortality rates. Ethics and dissemination The Voyage study will be conducted in accordance with international guidelines and local regulatory requirements and laws. Data will be stored and retained at Mayo Clinic. Only limited data elements required for research purposes will be transmitted between Mayo Clinic and Exact Sciences Laboratories. Results of the Voyage study will be disseminated through scientific presentations and publications. Trial registration number NCT04124406.