Whitmore Lauren, Schulte Taylor, Bovbjerg Katrin, Hartstein Madison, Austin Jane, Luta George, McFarland Lily, Rowley Scott D, Nyirenda Themba, Lewis-Thames Marquita, Stanton Annette L, Valdimarsdottir Heiddis, Graves Kristi, Rini Christine
John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA.
Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.
Trials. 2021 Oct 20;22(1):722. doi: 10.1186/s13063-021-05676-w.
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.gov NCT03800758 . Registered January 11, 2019.
在造血干细胞移植期间、移植后不久，有时甚至在移植后的数年里，很大一部分接受移植的血液系统癌症患者报告有明显的身体和心理症状，且与健康相关的生活质量下降。为了解决这些生存问题，我们开发了一种低负担、简短的心理干预措施，称为表达性帮助，它包括两个基于理论和证据的组成部分，旨在协同发挥作用：情感表达写作和同伴支持写作。基于先前一项随机对照试验的证据，该试验表明，长期存在生存问题的移植幸存者的身体症状和痛苦有所减轻，“洞察、力量与轻松写作”（WISE）试验将评估表达性帮助在移植期间和移植后早期（症状高峰期）使用时的疗效，以及该干预措施能否预防持续性症状的出现。
WISE是一项多中心、双臂随机对照疗效试验。计划接受造血干细胞移植的成年血液系统癌症患者将完成基线测量，然后在住院后但移植前，他们将被随机分配完成表达性帮助或时间和注意力“中性写作”任务。表达性帮助和中性写作都包括四个简短的写作环节，从随机分组后立即开始，到出院后约4周结束。症状负担（主要结局）、痛苦、与健康相关的生活质量和疲劳（次要结局）的测量将在与从基线到干预后一年的医学相关时间点相吻合的七次评估中进行。
干细胞移植使用的稳步持续增加，使得人们越来越需要有效且易于获得的干预措施，以减少这种具有挑战性但可能挽救生命的治疗带来的短期和长期负面身体及心理社会影响。表达性帮助是一种旨在填补这一空白的心理干预措施。它已被证明对长期移植幸存者有效，但如果它能够在移植期间及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.gov NCT03800758。2019年1月11日注册。
