10011 Background: Childhood cancer survivors are at risk of early cardiovascular disease (CVD). We conducted a survivorship care plan (SCP)-based counseling intervention to improve CVD risk factor control in adult-aged survivors. Methods: Randomized (1:1) trial of survivors at high CVD risk based on history of anthracycline or chest radiotherapy exposures with undertreated hypertension (≥130/80 mmHg), dyslipidemia (LDL ≥160 mg/dL or triglyceride ≥200 mg/dL), and/or glucose intolerance (threshold varied if history of pre-diabetes or diabetes) based on in-home testing. Approximating a survivorship clinic visit, the intervention consisted of a remotely delivered session with an advanced practice provider to review results, a SCP with personalized CVD risk information, and an action plan to help manage CVD risk factors. A remote booster session was provided 4 months later with the action plan updated. Control participants only received a copy of their in-home results with abnormalities noted and written encouragement to follow-up with their primary care provider (PCP). Blood pressure, lipid profile, and glucose tolerance were retested after 1y. For both groups, all participant materials were sent to PCPs throughout the study, and PCP medical records were abstracted at study completion. Logistic regression assessed the odds ratio (OR) for undertreatment at 1y associated with the intervention, adjusting for pre-specified variables (sex, current age, time since cancer, insurance status, recent history of survivorship clinic visit, and undertreated CVD risk factor). Results: Among 644 survivors who completed in-home testing, 347 met inclusion criteria and were randomized (175 intervention; overall 52% male, mean age 40y, 31y since cancer diagnosis); 264 with 1y follow-up (126 intervention). At baseline, rates of hypertension, dyslipidemia, and glucose intolerance were 53%, 52%, and 49%, respectively; 43% had > 1 undertreated condition. Although the intervention achieved > 95% satisfaction, it was not associated with reduced undertreatment vs control (OR 0.9, 95% CI 0.7-1.3). Notably, 48% of intervention and 44% of control participants had less undertreatment after 1y. In secondary analysis, greater internal locus of control was associated with less undertreatment at 1y (OR 0.7, 95% CI 0.6-0.9). The intervention group was more likely than controls to have CVD risk (+10 vs -1%), SCP (+17 vs -2%), and some late effects surveillance plan (+8 vs +2%) documented within PCP records at 1y vs baseline (p < 0.05 for all). Conclusions: While a remotely delivered counseling intervention did not reduce CVD risk factor undertreatment compared with provision of test results alone, both study arms had > 40% reduction in undertreatment. These results suggest that simply providing a formal CVD risk assessment to high-risk cancer survivors and their PCPs may be effective. Clinical trial information: NCT03104543 .
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