Protocol of a multisite randomized controlled trial of Bright IDEAS-Young Adults: Problem-solving skills training to reduce distress among young adults with cancer Journal Article
| Authors: | Devine, K. A.; Ohman-Strickland, P.; Barnett, M.; Donovan, K. A.; Thompson, L. M. A.; Manne, S. L.; Kearney, J.; Levonyan-Radloff, K.; Diaz, D.; Dugad, S.; Sahler, O. J. Z. |
| 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 |
| Abstract: | 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. © 2024 |
| Keywords: | adult; controlled study; young adult; systemic therapy; cancer diagnosis; quality of life; randomized controlled trial; health survey; depression; symptom; clinical education; multicenter study; distress syndrome; psychosocial care; therapy effect; anxiety; informed consent; university hospital; life expectancy; patient referral; parallel design; protocol; evaluation research; functional assessment of cancer therapy; health care survey; social problem; clinical outcome; exploratory research; patient-reported outcome; young adults; rct; behavioral intervention; cancer; human; male; female; article; malignant neoplasm; financial distress; clinical trial protocol; program efficacy; bright ideas; problem-solving skills; clinical research protocol; problem solving therapy |
| Journal Title: | Contemporary Clinical Trials |
| Volume: | 145 |
| ISSN: | 1551-7144 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2024-10-01 |
| Start Page: | 107656 |
| Language: | English |
| DOI: | 10.1016/j.cct.2024.107656 |
| PUBMED: | 39111386 |
| PROVIDER: | scopus |
| PMCID: | PMC11848848 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
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