{Reference Type}: Journal Article
{Title}: Protocol of a multisite randomized controlled trial of Bright IDEAS-Young Adults: Problem-solving skills training to reduce distress among young adults with Cancer.
{Author}: Devine KA;Ohman-Strickland P;Barnett M;Donovan KA;Thompson LMA;Manne SL;Kearney J;Levonyan-Radloff K;Diaz D;Dugad S;Sahler OJZ;
{Journal}: Contemp Clin Trials
{Volume}: 145
{Issue}: 0
{Year}: 2024 Aug 5
{Factor}: 2.261
{DOI}: 10.1016/j.cct.2024.107656
{Abstract}: <B>BACKGROUND: </B>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.<BR><B>METHODS: </B>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.<BR><B>CONCLUSIONS: </B>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.<BR><B>BACKGROUND: </B>clinicaltrials.gov #NCT04585269.