Barnett, Marie

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 .

This selection from the NCCN Guidelines for Adolescent and Young Adult (AYA) Oncology focuses on considerations for the comprehensive care of AYA patients with cancer. Compared with older adults with cancer, AYA patients have unique needs regarding treatment, fertility counseling, psychosocial and behavioral issues, and supportive care services. The complete version of the NCCN Guidelines for Adolescent and Young Adult (AYA) Oncology addresses additional aspects of caring for AYA patients, including risk factors, screening, diagnosis, and survivorship.