Efficacy of expressive helping in adult hematologic cancer patients undergoing stem cell transplant: protocol for the Writing for Insight, Strength, and Ease (WISE) study's two-arm randomized controlled trial.
Efficacy of expressive helping in adult hematologic cancer patients undergoing stem cell transplant: protocol for the Writing for Insight, Strength, and Ease (WISE) study's two-arm randomized controlled trial.
复制标题
DOI：
10.1186/s13063-021-05676-w
复制
发表时间：
2021-10-20
期刊：
影响因子：
2.5
通讯作者：
Rini C
中科院分区：
文献类型：
--
作者：
Whitmore L;Schulte T;Bovbjerg K;Hartstein M;Austin J;Luta G;McFarland L;Rowley SD;Nyirenda T;Lewis-Thames M;Stanton AL;Valdimarsdottir H;Graves K;Rini C
在造血干细胞移植期间，移植后不久，有时甚至在移植后数年，很大一部分接受移植的血液癌症患者报告了显著的身体和心理症状，并降低了与健康相关的生活质量。为了解决这些生存问题，我们开发了一种低负担，简短的心理干预，称为表达性帮助，包括两个理论和证据为基础的组件，旨在协同工作：情感表达写作和同伴支持写作。基于先前随机对照试验的证据，显示长期移植幸存者的身体症状和痛苦减少，持续生存问题，写作洞察力，力量和轻松（WISE）试验将评估表达性帮助在移植期间和移植后早期使用时的疗效，当症状达到高峰时，干预可以防止持续症状的发展。WISE是一项多中心、两组随机对照疗效试验。计划进行造血干细胞移植的成人血液癌症患者将完成基线测量，然后在住院后但在移植前，他们将被随机分配完成表达帮助或时间和注意力“中性书写”任务。表达性帮助和中性书写都涉及四次简短的书写，从随机化后立即开始，到出院后大约4周结束。症状负担（主要结局）、痛苦、健康相关生活质量和疲劳（次要结局）的测量将在7项评估中进行，这些评估与从基线到干预后一年的医学相关时间点一致。干细胞移植使用的稳定和持续增加，使人们越来越需要有效的、可获得的干预措施，以减少这种具有挑战性但可能挽救生命的治疗对身体和心理社会的短期和长期负面影响。表达性帮助是一种心理干预，旨在填补这一空白。它已被证明对长期移植存活者有效，但如果它能够在移植期间和移植后不久减轻症状，可能会产生更大的影响。WISE研究将在一项严格的随机对照试验中评估这些益处。Clinicaltrial.govNCT03800758.注册时间：2019年1月11日
During, shortly after, and sometimes for years after hematopoietic stem cell transplant, a large proportion of hematological cancer patients undergoing transplant report significant physical and psychological symptoms and reduced health-related quality of life. To address these survivorship problems, we developed a low-burden, brief psychological intervention called expressive helping that includes two theory- and evidence-based components designed to work together synergistically: emotionally expressive writing and peer support writing. Building on evidence from a prior randomized control trial showing reductions in physical symptoms and distress in long-term transplant survivors with persistent survivorship problems, the Writing for Insight, Strength, and Ease (WISE) trial will evaluate the efficacy of expressive helping when used during transplant and in the early post-transplant period, when symptoms peak, and when intervention could prevent development of persistent symptoms. WISE is a multi-site, two-arm randomized controlled efficacy trial. Adult hematological cancer patients scheduled for a hematopoietic stem cell transplant will complete baseline measures and then, after hospitalization but prior to transplant, they will be randomized to complete either expressive helping or a time and attention “neutral writing” task. Both expressive helping and neutral writing involve four brief writing sessions, beginning immediately after randomization and ending approximately 4 weeks after hospital discharge. Measures of symptom burden (primary outcome), distress, health-related quality of life, and fatigue (secondary outcomes) will be administered in seven assessments coinciding with medically relevant time points from baseline and to a year post-intervention. The steady and continuing increase in use of stem cell transplantation has created growing need for efficacious, accessible interventions to reduce the short- and long-term negative physical and psychosocial effects of this challenging but potentially life-saving treatment. Expressive helping is a psychological intervention that was designed to fill this gap. It has been shown to be efficacious in long-term transplant survivors but could have even greater impact if it is capable of reducing symptoms during and soon after transplant. The WISE study will evaluate these benefits in a rigorous randomized controlled trial. Clinicaltrial.govNCT03800758. Registered January 11, 2019
登录
查看更多内容
影响因子：
8.2
作者：
Brown, SL;Nesse, RM;Smith, DM
通讯作者：
Smith, DM
影响因子：
3.1
作者：
Heisler, Michele;Choi, HwaJung;Brown, Stephanie
通讯作者：
Brown, Stephanie
影响因子：
3.1
作者：
Bevans, Margaret F.;Mitchell, Sandra A.;Marden, Susan
通讯作者：
Marden, Susan
影响因子：
5.7
作者：
Chew, Lisa D.;Griffin, Joan M.;VanRyn, Michelle
通讯作者：
VanRyn, Michelle
影响因子：
3.1
作者：
Cella, David;Lai, Jin-Shei;Stone, Arthur
通讯作者：
Stone, Arthur