The ASPIRES study: Promoting colorectal cancer surveillance in childhood cancer survivors—A randomized intervention trial from the Childhood Cancer Survivor study (CCSS).

10004 Background: Survivors of childhood cancer exposed to abdominal, pelvic, spinal, or total-body radiotherapy (RT) are at elevated risk for subsequent treatment-related colorectal cancer (CRC). However, adherence to recommended CRC surveillance screening is only ~37%, leaving survivors vulnerable to potentially preventable cancer. Innovative interventions are needed to improve screening uptake. Methods: We conducted a three-arm randomized controlled trial comparing mHealth-based patient activation (PA) and patient plus primary care provider activation (PA+PCP) with a control arm that received a survivorship care plan with screening recommendations. Nested within the CCSS, eligible participants were 5-year survivors diagnosed before age 21 who had received abdominal, pelvic, spinal, or total-body radiotherapy and were not up to date with surveillance. Participants (n = 300) were randomized in a 1:1:1 ratio, stratified by age at enrollment (30–44 vs ≥45 years). The primary outcome was the proportion of participants who completed CRC surveillance within 12 months. Each intervention arm was compared with the control in an intent-to-treat analysis using the Cochran-Mantel-Haenszel test ( ꭤ = 0.025/comparison). In secondary analyses, logistic regression, adjusted for age at enrollment, was used to estimate odds ratios (ORs) to identify moderators of the relationship between the intervention (grouping PA with PA+PCP) and the outcome. Results: Participants were 45% male and 8% non-white, with a median age of 41 years (range: 30 – 67 years). At 12 months, survivors in the PA group were significantly more likely than controls to have completed surveillance screening: 32/99 (32%) vs 14/102 (14%) [p = 0.003]. Surveillance screening completion was also higher in the PA+PCP group than in controls, but this difference did not meet the prespecified α (0.025): 26/99 (26%) vs 14/102 (14%) [p = 0.041]. Secondary analyses suggested the intervention was more effective among survivors without a chronic health condition (without: OR = 3.6; 95%CI 1.5, 10.1 vs. with: OR=1.9; 95%CI 0.8, 4.8) and with ≤ high school education (≤ high school OR=4.4; 95%CI 1.3, 20.2 vs. > high school OR=2.2; 95%CI 1.1, 4.7). Conclusions: An mHealth-based patient activation intervention more than doubled adherence to CRC surveillance compared with a survivorship care plan with surveillance recommendations alone. While patient plus PCP activation showed improvement, adding PCP activation did not confer a significant benefit compared with the control. Intervention effectiveness varied across subgroups, underscoring the importance of tailored approaches. As digital technologies continue to advance, mHealth strategies offer a promising and scalable pathway to improving surveillance screening among high-risk survivors of childhood cancer. Clinical trial information: NCT05084833 .