Protocol of a multisite randomized controlled trial of Bright IDEAS-Young Adults: Problem-solving skills training to reduce distress among young adults with Cancer

Background: Young adults with cancer diagnosed between the ages of 18 to 39 are recognized as a vulnerable group with unique emotional, social, and practical needs that put them at risk of poor psychosocial outcomes and impaired health-related quality of life (HRQOL). This study describes the protocol of a randomized controlled trial to evaluate the efficacy of Bright IDEAS-Young Adults (Bright IDEAS-YA), a problem-solving skills training intervention, on psychosocial outcomes of young adults newly diagnosed with cancer. Methods: Bright IDEAS-YA is a two-arm, parallel, randomized controlled trial. Young adults are eligible if they are 18–39 years of age, within four months of a first cancer diagnosis, and receiving systemic therapy with life expectancy of at least six months. Participants are randomized 1:1 to Bright IDEAS-YA or enhanced usual care. Survey measures are completed at enrollment and 3, 6, 12, and 24 months. The primary endpoint will be the estimated change from baseline to 6 months in symptoms of depression, anxiety, and psychosocial HRQOL. The other time points are secondary endpoints. Mediators and moderators will be examined. Conclusions: This randomized trial will determine the efficacy of Bright IDEAS-YA on psychosocial outcomes for young adults newly diagnosed with cancer. Analyses will also examine mechanisms of action and potentially identify subgroups for whom the intervention is particularly useful. Trial registration: clinicaltrials.gov #NCT04585269.