Multisite Randomized Trial of Inpatient Palliative Care Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation.

Methods

We conducted a multisite randomized trial among adults undergoing autologous or allogeneic HSCT at three academic institutions.

我们在三所学术机构中对接受自体或异基因造血干细胞移植的成人进行了多中心随机试验。

Patients were randomly assigned to an inpatient palliative care (PC) intervention or usual care.

患者被随机分配接受住院姑息治疗(PC)干预或常规护理。

Intervention patients met with PC clinicians twice weekly during the HSCT hospitalization.

干预组患者在造血干细胞移植(HSCT)住院期间每周两次与姑息治疗临床医生会面。

Patients assigned to usual care could be referred to PC as per standard of care.

被分配到常规护理的患者可以根据标准护理流程被转诊至姑息治疗。

We assessed QOL (patient: Functional Assessment of Cancer Therapy-Bone Marrow Transplant; caregiver: Caregiver-Oncology-QOL), depression and anxiety symptoms (Hospital-Anxiety-and-Depression-Scale), and patients' post-traumatic stress disorder (PTSD) symptoms (PTSD Checklist) at baseline, week 2, and 3 and 6 months post-HSCT.

我们在基线时、移植后第2周、第3周以及移植后3个月和6个月评估了患者的生活质量（患者使用癌症治疗功能评估-骨髓移植版；照顾者使用照顾者-肿瘤学生活质量问卷）、抑郁和焦虑症状（医院焦虑抑郁量表）以及患者的创伤后应激障碍（PTSD）症状（PTSD检查表）。

The primary end point was patients' QOL at week 2 during hospitalization when patients experience their QOL nadir.

主要终点是患者在住院第2周时的生活质量，此时患者的生活质量达到最低点。

We used linear regression, adjusting for baseline scores, to evaluate the effect of the intervention on patient-reported outcomes at week 2.

我们使用线性回归，调整基线得分，来评估干预措施对第2周患者报告结果的影响。

We used linear mixed-effect models to assess the effect of the intervention on study outcomes longitudinally.

我们使用线性混合效应模型来纵向评估干预措施对研究结果的影响。

Results

We enrolled 68.7% (360/524) of eligible patients between October 2018 and July 2022.

我们在2018年10月至2022年7月期间招募了68.7%（360/524）的符合条件的患者。

Compared with those receiving usual care, patients receiving the intervention reported better QOL (adjusted mean difference [B], 6.3; SE, 0.1; P < .001), lower depression (B, -1; SE, 0.4; P = .026), and fewer PTSD symptoms (B, -1.9; SE, 0.9; P = .046) at week 2.

与接受常规护理的患者相比，接受干预的患者在第2周报告了更好的生活质量（调整后平均差异[B]，6.3；标准误[SE]，0.1；P < .001），更低的抑郁水平（B，-1；SE，0.4；P = .026），以及较少的创伤后应激障碍（PTSD）症状（B，-1.9；SE，0.9；P = .046）。

Patient-reported anxiety did not differ significantly between groups at week 2.

在第2周，两组患者报告的焦虑程度没有显著差异。

In longitudinal analyses, patients receiving the intervention reported a steeper decline in PTSD symptoms over 6 months post-HSCT (slope difference, -0.9; SE, 0.7; P = .012).

在纵向分析中，接受干预的患者在造血干细胞移植（HSCT）后6个月内报告了创伤后应激障碍（PTSD）症状的更陡峭下降（斜率差异，-0.9；标准误，0.7；P = .012）。

All other patient-reported outcomes did not differ longitudinally between the groups.

所有其他患者报告的结果在各组之间纵向分析上没有差异。

Conclusions

PC led to substantial improvements in patients' QOL, depression, and PTSD symptoms with sustained effects on PTSD symptoms up to 6 months post-HSCT.

心理护理显著改善了患者的生存质量、抑郁症状和创伤后应激障碍（PTSD）症状，并在造血干细胞移植后6个月内对PTSD症状产生了持续效果。