A pilot randomized clinical trial of a peer support intervention for hematopoietic stem cell transplantation.

This study assessed the feasibility, acceptability, and preliminary effects of a scalable peer support intervention to reduce psychological distress and enhance quality of life (QOL) post-HSCT.

本研究评估了一种可扩展的同伴支持干预措施的可行性、可接受性以及初步效果，旨在减少造血干细胞移植（HSCT）后的心理困扰并提高生活质量（QOL）。

We conducted a pilot randomized clinical trial evaluating the Supporting Transplant Experiences with Peer Program (STEPP), a 5-session, telephone-based intervention delivered by an HSCT survivor offering psychoeducation and coping strategies.

我们开展了一项试点随机临床试验，评估了支持移植体验同伴计划（STEPP），这是一个由造血干细胞移植（HSCT）幸存者提供的电话为基础的干预措施，包括心理教育和应对策略。

Participants were recruited 1 to 2 weeks pre-HSCT admission and randomized to STEPP or usual care.

参与者在HSCT入院前1至2周被招募，并随机分配到STEPP或常规护理。

Feasibility was defined as ≥60% enrollment and ≥60% completing ≥3 sessions.

可行性定义为≥60%的纳入率以及≥60%的参与者完成≥3次会话。

Acceptability was assessed using the Client Satisfaction Questionnaire (CSQ; ≥3/4 mean benchmark).

接受度使用客户满意度问卷（CSQ; ≥3/4的平均基准）进行评估。

PRO measures of anxiety, depression (Hospital Anxiety and Depression Scale), posttraumatic stress (Post-Traumatic Stress Disorder Checklist-Civilian Version), QOL (Functional Assessment of Cancer Therapy-Bone Marrow Transplant), social support (Social Support and Effectiveness Questionnaire), and self-efficacy (Cancer Self-Efficacy Scale) were assessed pre-HSCT and at 30 and 60 days post-HSCT.

在造血干细胞移植（HSCT）前以及移植后30天和60天，评估了焦虑、抑郁（医院焦虑抑郁量表）、创伤后应激障碍（平民版创伤后应激障碍检查表）、生活质量（癌症治疗功能评估-骨髓移植）、社会支持（社会支持与效果问卷）和自我效能（癌症自我效能感量表）的患者报告结果（PRO）测量。

Mixed-effects models explored preliminary effects.

混合效应模型探索了初步效果。

We enrolled 77% (90 of 117) of eligible patients (STEPP, n = 45; usual care, n = 45); 12 became ineligible due to HSCT cancellation or postponement.

我们招募了77%（90/117）符合条件的患者（STEPP组，n=45；常规护理组，n=45）；由于造血干细胞移植（HSCT）的取消或推迟，有12名患者变得不符合条件。

Among 78 active participants (mean age, 58.9 years [standard deviation, 12.3]; 57.7% women), all STEPP participants completed ≥3 sessions, and the mean CSQ score was 3.5.

在78名活跃参与者中（平均年龄58.9岁[标准差12.3]；57.7%为女性），所有STEPP参与者完成了≥3次会话，平均CSQ评分为3.5。

STEPP showed small-to-moderate improvements in day 30 anxiety (d = -0.36) and day 60 anxiety (d = -0.58), depression (d = -0.25), posttraumatic stress (d = -0.28), QOL (d = 0.48), social support (d = 0.36), and self-efficacy (d = 0.46).

STEPP 显示了第30天焦虑（d = -0.36）和第60天焦虑（d = -0.58）、抑郁（d = -0.25）、创伤后应激（d = -0.28）、生活质量（d = 0.48）、社会支持（d = 0.36）和自我效能（d = 0.46）的小到中等程度的改善。

STEPP exceeds feasibility and acceptability thresholds, showing promising psychosocial benefits warranting a fully powered multisite efficacy trial. This trial was registered at www.clinicaltrials.gov as NCT06010017.

STEPP 超越了可行性和可接受性的阈值，显示出有希望的心理社会益处，值得进行一个全功率的多中心效果试验。该试验已在 www.clinicaltrials.gov 注册，注册号为 NCT06010017。