Katie A. Devine , Pamela Ohman-Strickland , Marie Barnett , Kristine A. Donovan , Lora M.A. Thompson , Sharon L. Manne , Julia Kearney , Kristine Levonyan-Radloff , Diana Diaz , Sanjana Dugad , Olle Jane Z. Sahler
{"title":"多地点随机对照试验 \"光明 IDEAS--年轻人 \"方案：问题解决技能培训，减轻癌症青年患者的痛苦。","authors":"Katie A. Devine , Pamela Ohman-Strickland , Marie Barnett , Kristine A. Donovan , Lora M.A. Thompson , Sharon L. Manne , Julia Kearney , Kristine Levonyan-Radloff , Diana Diaz , Sanjana Dugad , Olle Jane Z. Sahler","doi":"10.1016/j.cct.2024.107656","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Conclusions</h3><p>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.</p></div><div><h3>Trial registration</h3><p><span><span>clinicaltrials.gov</span><svg><path></path></svg></span> #<span><span>NCT04585269</span><svg><path></path></svg></span>.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"145 ","pages":"Article 107656"},"PeriodicalIF":2.0000,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"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\",\"authors\":\"Katie A. Devine , Pamela Ohman-Strickland , Marie Barnett , Kristine A. Donovan , Lora M.A. Thompson , Sharon L. Manne , Julia Kearney , Kristine Levonyan-Radloff , Diana Diaz , Sanjana Dugad , Olle Jane Z. Sahler\",\"doi\":\"10.1016/j.cct.2024.107656\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Conclusions</h3><p>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.</p></div><div><h3>Trial registration</h3><p><span><span>clinicaltrials.gov</span><svg><path></path></svg></span> #<span><span>NCT04585269</span><svg><path></path></svg></span>.</p></div>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":\"145 \",\"pages\":\"Article 107656\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-08-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1551714424002398\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714424002398","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
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.
期刊介绍：
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
