Kearney, Julia A.

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

12005 Background: Young adults (YAs) diagnosed with cancer between the ages of 18 and 39 face unique psychosocial challenges and are at risk of experiencing significant emotional distress and poor health-related quality of life (HRQOL). This randomized trial evaluated the efficacy of Bright IDEAS-YA, a problem-solving skills training intervention, on reducing distress and improving HRQOL of YAs newly diagnosed with cancer. A secondary aim examined change in problem-solving ability as a potential mediator of treatment effects. Methods: A three-site randomized trial of Bright IDEAS-YA compared with enhanced usual care (EUC) enrolled YA survivors within four months of a first diagnosis of cancer. Participants were randomized 1:1 to Bright IDEAS-YA or EUC (NCT04585269). Bright IDEAS-YA is a 6-session, one-on-one intervention that teaches a systematic approach to overcome personal challenges across any life domain. EUC involved usual psychosocial care plus AYA resources. Participants completed surveys at 0 (baseline), 3, 6, 12, and 24 months, with 6 months as the primary endpoint. Validated measures included the PROMIS Depression Short Form and Anxiety Short Form (primary outcomes), the Functional Assessment of Cancer Therapy – General (FACT-G; primary outcome), and Social Problem-Solving Inventory-Revised Short Form (SPSI-R; mediator). Efficacy was tested using linear mixed effects models, run in R, examining the group x time interaction effects. Mediation was tested using the R multiple mediation analysis. Results: 344 YA (34.2% acceptance rate, M age = 30.3 years, SD = 6.3; 63% female, 37% male, < 1% non-binary) participated (100% planned enrollment), with 86% and 81% completing surveys at 3 and 6 months, respectively. Compared to baseline, the intervention arm showed statistically significant improvements in depression, anxiety, and HRQOL relative to the control group at 6 months. The intervention arm demonstrated an average reduction of 3.2 T-score points reduction in depression (95% CI [-4.9, -1.5], p < 0.001), 2.4 T-score points in anxiety (95% CI [-4.0, -0.81], p = 0.003), and 3.4 points improvement in total FACT-G (95% CI [0.34, 6.5], p = 0.029) relative to the control. These differences reflect clinically meaningful changes per published reports. Across all three models, change in total problem-solving ability (SPSI-R) was shown to mediate treatment effects, primarily due to change in the negative problem-orientation subscale. Conclusions: Bright IDEAS-YA was efficacious in reducing symptoms of depression and anxiety and improving HRQOL compared with enhanced usual care among YAs with cancer. Improvements are attributable to increased problem-solving ability, particularly by reducing the tendency to view problems as significant threats and doubt one’s ability to successfully solve problems. Clinical trial information: NCT04585269 .