1Department of Psychosocial Oncology, Dana-Farber Cancer Institute, Boston, MA.
2Department of Psychiatry, Brigham and Women's Hospital, Boston, MA.
J Natl Compr Canc Netw. 2024 Jun;22(2 D). doi: 10.6004/jnccn.2023.7117.
Allogeneic hematopoietic stem cell transplantation (HSCT) survivors experience significant psychological distress and low levels of positive psychological well-being, which can undermine patient-reported outcomes (PROs), such as quality of life (QoL). Hence, we conducted a pilot randomized clinical trial to assess the feasibility and preliminary efficacy of a telephone-delivered positive psychology intervention (Positive Affect for the Transplantation of Hematopoietic stem cells intervention [PATH]) for improving well-being in HSCT survivors.
HSCT survivors who were 100 days post-HSCT for hematologic malignancy at an academic institution were randomly assigned to either PATH or usual care. PATH, delivered by a behavioral health expert, entailed 9 weekly phone sessions on gratitude, personal strengths, and meaning. We defined feasibility a priori as >60% of eligible participants enrolling in the study and >75% of PATH participants completing ≥6 of 9 sessions. At baseline and 9 and 18 weeks, patients self-reported gratitude, positive affect, life satisfaction, optimism, anxiety, depression, posttraumatic stress disorder (PTSD), QoL, physical function, and fatigue. We used repeated measures regression models and estimates of effect size (Cohen's d) to explore the preliminary effects of PATH on outcomes.
We enrolled 68.6% (72/105) of eligible patients (mean age, 57 years; 50% female). Of those randomized to PATH, 91% completed all sessions and reported positive psychology exercises as easy to complete and subjectively useful. Compared with usual care, PATH participants reported greater improvements in gratitude (β = 1.38; d = 0.32), anxiety (β = -1.43; d = -0.40), and physical function (β = 2.15; d = 0.23) at 9 weeks and gratitude (β = 0.97; d = 0.22), positive affect (β = 2.02; d = 0.27), life satisfaction (β = 1.82; d = 0.24), optimism (β = 2.70; d = 0.49), anxiety (β = -1.62; d = -0.46), depression (β = -1.04; d = -0.33), PTSD (β = -2.50; d = -0.29), QoL (β = 7.70; d = 0.41), physical function (β = 5.21; d = 0.56), and fatigue (β = -2.54; d = -0.33) at 18 weeks.
PATH is feasible, with promising signals for improving psychological well-being, QoL, physical function, and fatigue in HSCT survivors. Future multisite trials that investigate PATH's efficacy are needed to establish its effects on PROs in this population.
异基因造血干细胞移植（HSCT）幸存者经历着显著的心理困扰和较低的积极心理幸福感，这可能会损害患者报告的结果（PROs），如生活质量（QoL）。因此，我们进行了一项试点随机临床试验，以评估电话传递积极心理学干预（Positive Affect for the Transplantation of Hematopoietic stem cells intervention [PATH]）对改善 HSCT 幸存者幸福感的可行性和初步疗效。
在学术机构接受血液恶性肿瘤的 HSCT 后 100 天的 HSCT 幸存者被随机分配到 PATH 或常规护理组。PATH 由行为健康专家提供，包括 9 次每周电话会议，内容涉及感激、个人优势和意义。我们预先定义了可行性，即>60%的合格参与者参加了研究，>75%的 PATH 参与者完成了 9 次电话会议中的≥6 次。在基线、9 周和 18 周时，患者自我报告了感激、积极情绪、生活满意度、乐观、焦虑、抑郁、创伤后应激障碍（PTSD）、QoL、身体功能和疲劳。我们使用重复测量回归模型和效应量估计（Cohen's d）来探讨 PATH 对结果的初步影响。
我们招募了 68.6%（72/105）的合格患者（平均年龄 57 岁；50%为女性）。随机分配到 PATH 的患者中，91%完成了所有的会议，并报告积极心理学练习易于完成且主观上有用。与常规护理相比，PATH 组在 9 周时报告了更高的感激感（β=1.38；d=0.32）、焦虑（β=-1.43；d=-0.40）和身体功能（β=2.15；d=0.23），以及在 18 周时报告了更高的感激感（β=0.97；d=0.22）、积极情绪（β=2.02；d=0.27）、生活满意度（β=1.82；d=0.24）、乐观（β=2.70；d=0.49）、焦虑（β=-1.62；d=-0.46）、抑郁（β=-1.04；d=-0.33）、创伤后应激障碍（β=-2.50；d=-0.29）、QoL（β=7.70；d=0.41）、身体功能（β=5.21；d=0.56）和疲劳（β=-2.54；d=-0.33）。
PATH 是可行的，有希望改善 HSCT 幸存者的心理幸福感、QoL、身体功能和疲劳。需要进行多中心试验来研究 PATH 在这一人群中的疗效，以确定其对 PROs 的影响。
