Bright IDEAS-YA Skills Training and Psychosocial Outcomes of Young Adults With Cancer: A Randomized Clinical Trial.
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IMPORTANCE: Young adults (YAs; ages 18-39 years) diagnosed with cancer face unique psychosocial challenges, including high distress and poor health-related quality of life (HRQOL). There are few efficacious interventions tailored to their needs. OBJECTIVE: To evaluate the efficacy of Bright IDEAS-YA, a problem-solving skills training intervention tailored for YAs, in reducing distress and improving HRQOL. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted at 3 academic medical centers and enrolled participants between February 2021 and March 2024. Eligible participants were aged 18 to 39 years, within 4 months of a first cancer diagnosis, and undergoing systemic therapy. Participants completed surveys at baseline and 3, 6, 12, and 24 months. INTERVENTION: Bright IDEAS-YA is a 6-session, one-on-one intervention that teaches a structured approach to problem-solving. Enhanced usual care (EUC) included standard psychosocial care plus a list of adolescent and YA resources. MAIN OUTCOMES AND MEASURES: Primary outcomes were depression and anxiety (Patient-Reported Outcomes Measurement Information System Short Forms) and HRQOL (Functional Assessment of Cancer Therapy-General) at 6 months. Problem-solving ability (Social Problem-Solving Inventory-Revised Short Form) was examined as a mediator. Analyses used linear mixed effects models and mediation analysis. RESULTS: Of the 1128 YAs screened, 344 YAs (median [IQR] age, 31.27 [25.78-36.38] years; 251 female [62.5%]) enrolled, with 171 allocated to intervention and 173 allocated to control. Overall, 296 YAs (86.0%) and 280 YAs (81.4%) completed 3- and 6-month surveys, respectively. At 6 months, the intervention group showed significantly greater improvements than EUC in depression (effect size estimate, -3.23 points; 95% CI, -4.93 to -1.53 points; P < .001), anxiety (effect size estimate,-2.43 points; 95% CI, -4.05 to -0.81 points; P = .003), and HRQOL (effect size estimate, 3.40 points; 95% CI, 0.34 to 6.45 points; P = .03). These changes were clinically meaningful. Mediation analyses showed that improvements in depression and anxiety were partially due to increased problem-solving ability, particularly reductions in negative problem orientation. Sex and education were moderators of treatment effect, with the treatment effect on anxiety being greater for males (effect size estimate, -5.29 points; 95% CI, -7.97 to -2.60 points) and the treatment effect on anxiety (effect size estimate, -6.94 points; 95% CI, -10.50 to -3.43 points) and depression (effect size estimate, -7.47 points; 95% CI, -11.20 to -3.74 points; P < .001) being greater for those with lower education. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of Bright IDEAS-YA, intervention participants had significantly reduced distress and improved HRQOL relative to control. These findings suggest that Bright IDEAS-YA may be offered as supportive care for YAs with cancer to improve psychosocial outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04585269.