Counseling and Cardiovascular Disease Risk Factor Control in Long-Term Cancer Survivors: A Randomized Clinical Trial.
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IMPORTANCE: Survivors of childhood cancer have an increased risk of cardiovascular disease (CVD). However, many survivors at high risk do not receive recommended CVD screening tests as young adults. OBJECTIVE: To assess whether a survivorship care plan (SCP)-based counseling intervention improves CVD risk factor control in high-risk survivors. DESIGN, SETTING, AND PARTICIPANTS: The Communicating Health Information and Improving Coordination With Primary Care (CHIIP) Study was a randomized clinical trial that enrolled eligible participants from the Childhood Cancer Survivor Study cohort in 9 US metropolitan areas between August 2017 and April 2020, with follow-up completed July 2022. Participants included adult survivors of childhood cancer exposed to cardiotoxic cancer therapies with undertreated CVD risk factors (hypertension, dyslipidemia, and glucose intolerance defined by standard guidelines); of 1840 survivors approached, 842 consented to participate, and 347 met all eligibility requirements and were randomized after a baseline home assessment. Data analysis was completed March 18, 2025. INTERVENTION: The intervention consisted of a single remote session to review measurements and a SCP with personalized CVD risk information and to develop a CVD risk factor management plan, with a booster session 4 months later. Enhanced care controls received measurements with abnormal findings noted and written encouragement to follow up with their primary care clinician (PCC). PCCs received all materials sent to participants. MAIN OUTCOMES AND MEASURES: Blood pressure, lipid profile, and glucose and hemoglobin A1c levels collected by a trained home examiner at baseline and 1-year follow-up, with undertreatment defined by standard guidelines. RESULTS: A total of 347 cancer survivors (mean [SD] age, 40.5 [9.4] years; 182 [52.4%] male) were randomized, 175 to the intervention group and 172 to the enhanced care control group. Of these, 194 participants (53.0%) participants had undertreated hypertension at baseline; 180 (51.9%), undertreated dyslipidemia; and 170 (49.0%) undertreated glucose intolerance. After 1 year, 45 of 173 surviving intervention participants (26.0%) and 52 of 172 enhanced care control participants (30.2%) had less undertreatment, with lower percentages for each condition vs baseline. Although the intervention did not reduce undertreatment compared with the control condition (odds ratio, 1.31; 95% CI, 0.84-2.05), greater engagement was associated with less undertreatment at 1 year among intervention participants (odds ratio, 0.31; 95% CI, 0.18-0.72). The intervention group had improved PCC documentation of CVD risk vs controls after 1 year (14.8% improvement vs 0.9%; P = .002). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of long-term survivors of childhood cancer, the addition of survivorship-based self-management counseling did not reduce undertreatment beyond simply providing CVD risk assessments to survivors and PCCs. Additional strategies to mitigate CVD risk in high-risk survivors should be examined in the future. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03104543.