Initial Impact of Tailored Web-Based Messages About Cigarette Smoke and Breast Cancer Risk on Boys’ and Girls’ Risk Perceptions and Information Seeking: Randomized Controlled Trial

Background Recent evidence indicates a causal link between both active smoking and secondhand smoke (SHS) exposure and breast cancer (BC). Objective The objective of the present study was to evaluate the initial reactions of girls and boys to tailored Web-based messages that describe the relationship between SHS and BC, using a parallel, single-blinded cluster randomized controlled trial. Methods This trial was nested within a cycle of an ongoing longitudinal study of 1498 students from 74 secondary schools. Self-reported assessments were used to evaluate the impact of study messages on participants’ risk perception and interest in obtaining additional information after participants were randomized by schools to control or intervention groups. The intervention group received a tailored visual message (based on gender and Aboriginal status) about BC and tobacco smoke. The control group received a standard visual message about smoking and cancer. Results SHS exposure was identified as a BC risk factor by 380/1488 (25.54%) participants, during the preintervention analysis. Compared to the female participants in the control group (491/839, 58.5%), girls who received the intervention (339/649, 52.2%) were 14% more likely to agree that exposure to SHS increased their BC risk (relative risk [RR] 1.14, 95% CI 1.07-1.21). Nonsmoking girls who received the intervention were 14% more likely to agree that starting smoking would increase their BC risk (RR 1.14, 95% CI 1.07-1.21). Compared to the male participants in control group (348/839, 41.5%), boys who received the intervention (310/649, 47.8%) were 10% more likely to agree that girls’ exposure to SHS increased their BC risk (RR 1.10, 95% CI 1.02-1.18). Compared to controls, girls who received the intervention were 52% more likely to request additional information about SHS and BC (RR 1.52, 95% CI 1.12-2.06). Conclusions Brief gender-sensitive messages delivered via the Internet have the potential to increase awareness and to stimulate information seeking about the risk for BC associated with SHS.

INTRODUCTION 2a-i) Problem and the type of system/solution Yes -see this text "The delivery of messages describing the link between tobacco exposure and an increased risk of BC appears to represent an opportunity to take advantage of a naturally occurring teachable moment to promote reductions in tobacco exposure among adolescents.Within the context of cancer prevention, gender has been found to influence responses to teachable moments [28] and there is a growing body of research describing the profound influence of gender on health behavior [29].Although gender-related factors influencing smoking initiation and patterns of exposure to tobacco have begun to be described, few attempts to develop gender-sensitive tobacco reduction interventions have been made [30]." and "This study was an application of the teachable moment heuristic.The primary aim was to examine youths' responses to web-based, gender-and Aboriginal-tailored messages regarding the link between tobacco exposure and risk of BC. " 2a-ii) Scientific background, rationale: What is known about the (type of) system Yes -see this text "The delivery of messages describing the link between tobacco exposure and an increased risk of BC appears to represent an opportunity to take advantage of a naturally occurring teachable moment to promote reductions in tobacco exposure among adolescents.Within the context of cancer prevention, gender has been found to influence responses to teachable moments [28] and there is a growing body of research describing the profound influence of gender on health behavior [29].Although gender-related factors influencing smoking initiation and patterns of exposure to tobacco have begun to be described, few attempts to develop gender-sensitive tobacco reduction interventions have been made [30]."METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio Yes -see this text "This study was an application of the teachable moment heuristic.The primary aim was to examine youths' responses to web-based, gender-and Aboriginal-tailored messages regarding the link between tobacco exposure and risk of BC.We hypothesized that exposure to the tailored messages compared with a general message describing the carcinogenic aspects of tobacco smoke would result in: (a) an increased probability of indicating that tobacco exposure is associated with an increased risk of BC; and (b) an increased probability of opting to receive more information about tobacco exposure and BC.In addition to the aforementioned primary hypotheses, we tested a secondary hypothesis that exposure to the tailored messages would be associated with more time spent viewing the messages.Each of the hypotheses was adapted to groups defined by their sex (girls and boys) and smoking status (smokers and non-smokers)."3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons Yes.No changes to report 3b-i) Bug fixes, Downtimes, Content Changes Yes.No changes to report 4a) CONSORT: Eligibility criteria for participants Yes -see this text from the Trial Design section of the Methods in the manuscript which describes eligibility criteria and recruitment procedures.
"The START study was nested within the longitudinal British Columbia Adolescent Substance Use Survey (BASUS) and is a parallel, single-blinded cluster randomized control trial.Randomization was conducted at the school level prior to enrolment.Students were initially recruited into the BASUS study from 48 participating public secondary schools in British Columbia, Canada.All BASUS participants were 13 years of age or older, able to read and complete an internet-based survey in English, and provided informed consent, as well as written parental consent in schools requiring participants to provide parental consent.In order to prevent the enrolment of ineligible participants (e.g., non-students), participants were recruited in person in a school environment.After viewing a brief presentation during home room class, eligible students were given an information package that contained a unique login code to set up an account on the survey website.Students completed the web-based survey during their own time or in some cases in school computer labs during scheduled class time.Each participant received a $25 honorarium in the form of a gift card (mailed to their home address) for participating in each wave of the BASUS survey."4a-i) Computer / Internet literacy Yes -see this section of text from the description of the Trial Design: "ability to read and complete the internet-based survey in English" 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Yes -the following text describes the recruitment and assessment process: "participants were recruited in person in a school environment.After viewing a brief presentation during home room class, eligible students were given an information package that contained a unique login code to set up an account on the survey website.Students completed the web-based survey during their own time or in some cases in school computer labs during scheduled class time.Each participant received a $25 honorarium in the form of a gift card (mailed to their home address) for participating in each wave of the BASUS survey."4a-iii) Information giving during recruitment Yes -see this section of the text for a description of recruitment and consent procedures: "Students were initially recruited into the BASUS study from 48 participating public secondary schools in British Columbia, Canada.All BASUS participants were 13 years of age or older, able to read and complete an internet-based survey in English, and provided informed consent, as well as written parental consent in schools requiring participants to provide parental consent.In order to prevent the enrolment of ineligible participants (e.g., non-students), participants were recruited in person in a school environment.After viewing a brief presentation during home room class, eligible students were given an information package that contained a unique login code to set up an account on the survey website.Students completed the web-based survey during their own time or in some cases in school computer labs during scheduled class time.Each participant received a $25 honorarium in the form of a gift card (mailed to their home address) for participating in each wave of the BASUS survey.School specific response rates varied from 2% to 100%, with an average of 20%.For the purposes of the START study, schools (n=74) were stratified by total number of enrolled students and number of self-identified Aboriginal students at each school (based on data from previous waves of the survey)." 4b) CONSORT: Settings and locations where the data were collected Yes -the abstract describes the assessments as " Self-reported assessments" in the Methods section.The Methods section of the Manuscript provides the specific wording of the self reported assessments included in the web-survey in the "Measures" section.4b-i) Report if outcomes were (self-)assessed through online questionnaires Yes -the abstract describes the assessments as " Self-reported assessments" in the Methods section.The Methods section of the Manuscript provides the specific wording of the self reported assessments included in the web-survey in the "Measures" section.4b-ii) Report how institutional affiliations are displayed Yes.We do not feel that institutional identification influenced the results of this study.5) CONSORT: Describe the interventions for each group with sufficient details to allow replication, including how and when they were actually administered 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners Yes -The intervention consisted of single images that are provided in the Methods section.The development of the images is described in Intervention and Control sections of the Methods section of the manuscript.We do not feel that a Conflict of Interest statement is warranted given the nature of this study.5-ii) Describe the history/development process Yes -The intervention consisted of single images that are provided in the Methods section.The development of the images is described in Intervention and Control sections of the Methods section of the manuscript.

5-iii) Revisions and updating
Yes.There was only one final Version of the images used in this study.The development of the images is described in Intervention and Control sections of the Methods section of the manuscript.5-iv) Quality assurance methods Yes.The intervention consisted of single jpeg images delivered in an web-based survey.The web-survey functioning and image display properties were tested across the major internet browsers in use at the time of the web survey.5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Yes.We have included the images (control and intervention) in the manuscript.5-vi) Digital preservation Yes.We have included the images (control and intervention) in the manuscript.5-vii) Access Yes.The images were displayed as part of an ongoing longitudinal web-based survey of secondary school students.An honorarium of $25 was provided to participants in this study.5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework Yes.The theoretical framework is based on the "Teachable Moment" theoretical framework.The study also integrates tailoring for gender and Aboriginal status.This is discussed in detail in the Introduction and Methods section of the manuscript.5-ix) Describe use parameters Yes.Does not apply to this study.5-x) Clarify the level of human involvement Yes.The intervention did not include any human involvement.5-xi) Report any prompts/reminders used Yes.This study reports the initial responses to the delivery of images displayed in a web-survey.The self-assessed responses were collected as part of the survey that contained the images so no prompts or reminders were used in this study.5-xii) Describe any co-interventions (incl.training/support) Yes.There were no co-interventions associated with this study.6a) CONSORT: Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Yes.The following text contains our primary and secondary hypotheses.
"This study was an application of the teachable moment heuristic.The primary aim was to examine youths' responses to web-based, gender-and Aboriginal-tailored messages regarding the link between tobacco exposure and risk of BC.We hypothesized that exposure to the tailored messages compared with a general message describing the carcinogenic aspects of tobacco smoke would result in: (a) an increased probability of indicating that tobacco exposure is associated with an increased risk of BC; and (b) an increased probability of opting to receive more information about tobacco exposure and BC.In addition to the aforementioned primary hypotheses, we tested a secondary hypothesis that exposure to the tailored messages would be associated with more time spent viewing the messages." The specific wording for the self-reported assessments are provided in the "Measures" section of the Methods of the manuscript.6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed Yes.The assessments used in this survey were single item assessments used in the scientific literature.The specific wording for the self-reported assessments are provided in the "Measures" section of the Methods of the manuscript.6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Yes.We included a secondary hypothesis related to the time spent viewing the messages.See the following text from the section of the manuscript entitled Message viewing times in intervention and control groups: "The time of the initial display of the message was recorded by the survey system followed by the time of the response to the question immediately following the display of the message.The difference between these two times was treated as the message viewing time with the recognition that it includes reading and answering a single demographic question that followed the presentation of the message (i.e., "How would you describe your household's financial situation?")." 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Yes.No qualitative feedback was collected for this investigation.6b) CONSORT: Any changes to trial outcomes the trial commenced, with reasons Yes. were no changes to the trial outcomes after the trial commenced.7a) CONSORT: How sample size was 7a-i) Describe whether and how expected attrition was into account when calculating the sample size Yes.The a size calculation for the study are reported in the manuscript under the Power analysis" in the Methods section of the There was no attrition the assessments were conducted immediately after presentation of the images during the same survey.7b) CONSORT: When applicable, explanation of any interim analyses and stopping guidelines This is not to this study.CONSORT: Method used to generate the random allocation sequence Yes.We the type of stratified randomization and process in the Trial design section of manuscript.See the following text: "For the purposes of the START study, schools (n=74) were stratified by total number of enrolled students and number of self-identified Aboriginal students at each school (based on data from previous waves of the survey).Randomization was based on a random-number generator in MS Excel; the research manager kept the master allocation list in a password-protected computer.Out of 1593 Wave 4 participants participating from April to June 2011, a sub-sample (n= 1,498) of participants were randomized to either the intervention or the control arm, after meeting general BASUS eligibility criteria, declaring their school, and identifying their gender and Aboriginal status (Figure 1).Although researchers were not blinded to the allocation, the participants were." 8b) CONSORT: Type of randomisation; details of any restriction (such as blocking and block size) Yes.Stratified used -see the following text: "For the purposes of the START study, schools (n=74) were stratified by total number of enrolled students and number of self-identified Aboriginal students at each school (based on data from previous waves of the survey)." 9) CONSORT: Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the interventions were assigned Yes.See following text: "For the purposes of the study, schools (n=74) were stratified by total number of students and number of self-identified Aboriginal students at each school (based on data from previous waves of the survey).Randomization was based on a random-number generator in MS Excel; the research manager kept the master allocation list in a password-protected computer.Out of 1593 Wave 4 participants participating from April to June 2011, a sub-sample (n= 1,498) of participants were randomized to either the intervention or the control arm, after meeting general BASUS eligibility criteria, declaring their school, and identifying their gender and Aboriginal status (Figure 1).Although researchers were not blinded to the allocation, the participants were." 10) CONSORT: Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Yes.High school were enrolled during presentations given to them during school -usually their room class.The presentations were given by researchers working on the study or who were provided with a detailed description of the The random assignment was determined prior to the collection of data by a research assistant as described in the following text: "Randomization was based on a random-number generator in MS Excel; the research manager kept the master allocation list in a password-protected computer.Out of 1593 Wave 4 participants participating from April to June 2011, a sub-sample (n= 1,498) of participants were randomized to either the intervention or the control arm, after meeting general BASUS eligibility criteria, declaring their school, and identifying their gender and Aboriginal status (Figure 1).Although researchers were not blinded to the allocation, the participants were."11a) CONSORT: Blinding -If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) how 11a-i) Specify was blinded, and who wasn't Yes.Participants were blind to assignment.Researchers were not blinded.11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Yes.Participants were not aware of the intervention or control status of the message they received.11b) CONSORT: If relevant, description of the similarity of interventions Yes.Both the control and intervention images are presented in the manuscript.Both are single images provide information on increased risk cancer associated with cigarette smoke exposure.12a) CONSORT: Statistical methods used to compare groups for primary and secondary outcomes Yes.Randomization was carried out at the school level and an adjust for this clustering was made in the analyses.See the following text: "To check for potential failures in randomization, potential confounders were identified via univariate tests and any variables found to differ significantly between the treatment and control groups were included as covariates in the subsequent multivariate models.Bivariate analyses of the categorical data were conducted using Fisher's exact test (P value < .05).A generalized estimating equation (GEE) was used for all regression models to adjust the standard errors of the parameter estimates for the correlated responses of students within the same school [32].Adjusted relative risks were estimated using a modified Poisson regression, with robust error variance [33], originally proposed by Lee and Chia [34] for binary outcomes [35].The robust error variance estimator was used because Poisson regression of binary outcomes tends to overestimate the standard errors [33,36].Analyses were Intention to Treat.The statistical analysis was completed with IBM® PASW® Statistics 19." 12a-i) Imputation techniques to deal with attrition / missing values Yes.There was no attrition as this study reports on data collected in the same survey that contained the intervention images.12b) CONSORT: Methods for additional analyses, such as subgroup analyses and adjusted analyses Yes.Analyses were adjusted for variables that were not balanced by the randomization.See the following text: "To check for potential failures in randomization, potential confounders were identified via univariate tests and any variables found to differ significantly between the treatment and control groups were included as covariates in the subsequent multivariate models.Bivariate analyses of the categorical data were conducted using Fisher's exact test (P value < .05).A generalized estimating equation (GEE) was used for all regression models to adjust the standard errors of the parameter estimates for the correlated responses of students within the same school [32].Adjusted relative risks were estimated using a modified Poisson regression, with robust error variance [33], originally proposed by Lee and Chia [34] for binary outcomes [35].The robust error variance estimator was used because Poisson regression of binary outcomes tends to overestimate the standard errors [33,36].Analyses were Intention to Treat." 13a) CONSORT: For the numbers of participants who were randomly assigned, received intended and were analysed for the primary outcome Yes.These are provided in the Trial flow diagram and the results.13b) CONSORT: For each group, losses and exclusions after randomisation, together with reasons Yes.This is information provided in the Trial flow diagram.From the diagram it can be seen that 95 of the 1593 potential START participants logged on to the main BASUS survey but did not proceed to the START component of the survey.13b-i) Attrition diagram Yes.There was no attrition as this study reports on data collected in the same survey that contained the intervention images.14a) CONSORT: Dates defining the periods of recruitment and follow-up Yes.There is no follow-up component to this study.
Indicate if critical "secular events" fell into the study period Yes.This is not relevant as this study collected information on the impact of the intervention immediately after delivery of the intervention messages.14b) CONSORT: Why the trial ended or was stopped (early) Yes.The trial was not stopped.15) CONSORT: A table showing baseline demographic and clinical characteristics for each group Yes.This is provided in Table 1 of the manuscript.15-i) Report demographics associated with digital divide issues Yes.We report demographics associated with digital divide issues in Table 1 of the manuscript.
CONSORT: For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 16-i) Report multiple "denominators" and provide definitions Yes.The flow diagram and table of results provide the 16-ii) Primary analysis should be intent-to-treat Yes.analysis is based on intention-to-treat.17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Yes.We included 95% CI's for all effects.17a-i) Presentation of outcomes such as metrics of use and intensity of use Yes.included the testing of a secondary hypothesis that involved assessing the length of time of the messages viewed.information is described in the following text taken from the manuscript: "The time of the initial display of the message was recorded by the survey system followed by the time of the response to the question immediately following the display of the message.The difference between these two times was treated as the message viewing time with the recognition that it includes reading and answering a single demographic question that followed the presentation of the message (i.e., "How would you describe your household's financial situation?")." 17b) CONSORT: For binary outcomes, presentation of both absolute and relative effect sizes is recommended This is provided in Table 2 of the manuscript.18) CONSORT: of any other analyses including subgroup analyses analyses, distinguishing pre-specified exploratory Yes.We clearly differential our primary hypotheses from the secondary hypothesis tested in study.18-i) Subgroup analysis of comparing only Yes -this is not very relevant to this study given the nature the intervention.19) CONSORT: All important harms or unintended effects in each group Yes. were no harms or effects associated with study that we are aware of.19-i) Include privacy breaches, technical problems Yes.There were no privacy breaches or technical problems.19-ii) Include qualitative feedback from participants or observations from staff/researchers Yes.There was no feedback the START study collected from participants.DISCUSSION CONSORT: Trial limitations, addressing of potential bias, imprecision, multiplicity of analyses Typical limitations in ehealth trials Yes.The major limitation is that we are reporting on the impact immediately following the delivery of images and the differences in risk perception may not be sustained over time.We discuss this in the recommendations for further research.We also acknowledge the low number of Aboriginal participants which limits the precision and generalizability of findings to this specific sub-population of students.This is acknowledged in the Discussion section of the manuscript.21) CONSORT: Generalisability (external validity, applicability) of the trial findings 21-i) Generalizability to other populations Yes.We identify a potential limitation related to the generalizability of the finding to Aboriginal youth given the relatively low number of Aboriginal participants in this study.We report a similar limitation for youth smokers.See for example the text below: "Additionally, the relatively small number of Aboriginal participants and adolescents who had tried smoking at the time of the survey may have reduced the statistical power and generalizability of the results to these particular groups."21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting Yes.This is not relevant to this study.22) CONSORT: Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Yes.For example see paragraph below from the Discussion section of the manuscript. " The findings indicate that the youth-informed, gender-sensitive messaging approach had positive effects on the awareness of SHS exposure as a risk factor for BC as well as on the information seeking behavior of girls.Compared with the standard message control group, the girls that received the tailored intervention were 14% more likely to agree that being exposed to SHS increased their risk of BC.The girls that identified as non-smokers and the intervention were also 14% more likely to agree that starting smoking would increase their risk of BC.Finally, compared with the girls in the control group, the girls that received the intervention were 52% more likely to request additional information about the relationship between SHS exposure and BC." 22-ii) Highlight unanswered new questions, suggest future research Yes.For example, we explicitly identify the need for: "longitudinal evaluation of the intervention's impact on health behavior (e.g., reduced up-take of smoking, reduced exposure to SHS)" Other information 23) CONSORT: Registration number and name of trial registry No. START was not originally registered in clinicaltrials.govdue to its designation as minimal risk study by UBC ethics, and its purpose was to examine the effect of employing a teachable moment heuristic to explore whether brief exposure to a tailored message about breast cancer and second hand smoke has immediate effects on perceived risk of SHS, knowledge about SHS and BC, and interest in receiving more information on the relationship between SHS and BC.24) CONSORT: Where the full trial protocol can be accessed, if available No. The trial protocol is quite simple and we feel that it is well described in the manuscript."This study and the longitudinal BASUS study received ethics approval from the University of British Columbia Behavioral Research Ethics Board."x26-ii) Outline informed consent procedures Yes. from participants was obtained online by clicking continue after reading a consent screen.Consent from parents was either passive (students given information packages to take home to their parents) or active (students had to bring a signed consent form in to their school in order to be emailed a log in code for the survey.The requirement for active or passive consent varied across schools.X26-iii) Safety and security procedures Yes.All students were provided with a unique login code to complete the survey.All data was kept on a secure server and all personally identifiable information (e.g.name, email address or mailing address) was stored in an encrypted database that was physically separate from the survey response database.
We did not anticipate any potential harm associated with viewing the messages though information on a toll free 24 hr youth crisis line was to provided to youth as part of the information displayed on the login web page page.X27-i) State the relation of the study team towards the system being evaluated Yes.The manuscript explicitly identifies the researchers as of intervention messages being evaluated.
25) CONSORT: Sources of funding and other support as supply of drugs), role of funders Yes.See text below: "This research was supported by funding from the Canadian Breast Cancer Research Alliance and the Breast Cancer Foundation (grant # 020659), and with scholar awards from the Michael Smith Foundation for Health Research Scholar to Dr. and from the Canadian Institutes of Health Research to Dr. Richardson." X26-i) Comment on ethics committee approval Yes.The following text in Trial Design section of the manuscript: