South Asian Heart Risk Assessment (SAHARA): Randomized Controlled Trial Design and Pilot Study

Background: People of South Asian origin suffer a high burden of premature myocardial infarction (MI). South Asians form a growing proportion of the Canadian population and preventive strategies to mitigate the risk of MI in this group are needed. Prior studies have shown that multimedia interventions are effective and feasible in inducing health behavior changes among the obese, smokers, and among those who are sedentary. Objective: Among at-risk South Asians living in Canada, our objectives are to determine: (1) the feasibility of a culturally tailored multimedia intervention to induce positive behavioral changes associated with reduced MI risk factors, and (2) the effectiveness and acceptability of information communicated by individualized MI and genetic risk score (GRS) reports. Methods: The South Asian HeArt Risk Assessment (SAHARA) pilot study enrolled 367 individuals of South Asian origin recruited from places of worship and community centers in Ontario, Canada. MI risk factors including the 9p21 genetic variant status were provided to all participants after the baseline visit. Participants were randomly allocated to receive a multimedia intervention or control. The intervention group selected health goals and received personalized health messages to promote adherence to their selected goals. After 6 months, all participants had their MI risk factors repeated. The methods and results of this study are reported based on the CONSORT-EHEALTH guidelines. Results: The mean age of participants was 53.8 years (SD 11.4), 52.0% (191/367) were women, and 97.5% (358/367) were immigrants to Canada. The mean INTERHEART risk score was 13.0 (SD 5.8) and 73.3% (269/367) had one or two copies of the risk allele for the 9p21 genetic variant. Both the intervention and control groups made some progress in health behavior changes related to diet and physical activity over 6 months. Participants reported that their risk score reports motivated behavioral changes, although half of the participants could not recall their risk scores at the end of study evaluation. Some components of the multimedia intervention were not widely used such as logging onto the website to set new health goals, and participants requested having more personal interactions with the study team.

Can a brief multimedia intervention facilitate breast cancer patients’ communication about sexual health? Findings from a randomized controlled trial.

e24179 Background: Many women with breast cancer (BC) lack the confidence to discuss sexual health with their clinicians. We evaluated, in a randomized controlled trial, a brief multimedia intervention designed to facilitate BC patients’ communication about sexual health. Methods: We randomly assigned BC patients to either a multimedia sexual/menopausal health communication skills intervention [ Starting the Conversation (STC), including a video, workbook, and pamphlet with local and web-based resources] or a control [resource guide only]. About 1-2 weeks after patients received materials, we audio recorded a clinic encounter with their BC provider, and subsequently coded the dialogue for patients raising the topic of sexual health or asking > 1 sexual health question. Self-report surveys administered at baseline, post-intervention, and 2-month follow-up assessed patients’ self-efficacy for discussing sexual health with their BC providers, sexual function, anxiety and depression, and quality of life. T-tests or mixed-effects logistic regression compared study arms; analyses of communication outcomes (patient raising the topic or asking a question during clinic encounter) were clustered by providers. Results: Study participants were 144 BC outpatients (82% acceptance rate; mean age = 56; 67% white; 15% metastatic; 31% active treatment). Women in the STC arm versus the control arm were more likely to raise the topic of sexual health [OR = 2.48 (1.11, 5.55), p= .03] and more likely to ask a sexual health question [OR = 2.93 (1.04, 8.26), p= .04]. Specifically, 51% of women in the STC arm raised the topic of sexual health versus 30% in the control arm and 40% of women in the STC arm asked a sexual health question versus 19% in the control arm. At 2-month follow-up, women in the STC arm showed greater improvements in self-efficacy ( p= .03) and anxiety, t(139) = 2.0, p= .04) compared to the control arm. Conclusions: STC, a brief multimedia intervention, was effective in facilitating BC patients’ communication about sexual health during routine clinic encounters and significantly reduced patients’ anxiety, possibly due to greater patient confidence in expressing their medical needs. Future studies should use longer-term follow-up and examine how sexual health communication can translate to improved patient sexual outcomes. Clinical trial information: NCT03624972 .