Supplementary Material for: Effects of a Sound Intervention on Physical and Emotional Well-Being in Patients with Cancer: A Prospective Randomized Trial

Aim: Cancer remains a disease with a significant impact on morbidity and mortality but also on quality of life. This prospective randomized pilot study investigated the effects of a sound intervention on physical and emotional well-being in outpatients with cancer. Methods: Two self-applied sound interventions were used for this purpose, either active “music playing” with a body monochord or passive sound intervention with headphones to listen to a given music compilation. Interventions were carried out over a period of 4 weeks for at least 15 min in the evening before bedtime. The following self-assessment questionnaires were completed both at baseline and after 4 weeks to evaluate the response: the Pittsburgh Sleep Quality Index (PSQI), the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), Visual Analogue Scale (VAS) for pain and fatigue, and the Fear of Progression (FoP) questionnaire. Primary endpoint of this exploratory trial was to describe the rate of patients with improvement in at least one dimension without worsening of any other. Results: 73 patients (29 male, 44 female) were included in the study and randomized to either active (n = 34, 47%) or passive sound intervention (n = 39, 53%). Median age was 52.0 years (range 21–79). Fourteen patients (19%) stated that they were musically active. The sound intervention was carried out on a median of 26 days (range 5–28). A higher percentage of patients in the passive group reached the primary endpoint: n = 15 (39%) versus n = 9 (27%). Response differences in favour of the passive group were seen with the VAS fatigue and with QLQ-30 questionnaires. Overall, an improvement in QLQ-30 questionnaire was seen in 12 patients (31%) in the passive group versus 3 patients (9%). Moreover, sound intervention significantly improved social functioning and shortness of breath in the passive group according to QLQ-C30. Significant improvements were also noticed in the passive group in terms of affective reactions as a domain of the FoP questionnaire. No effects on pain or sleep quality could be observed. Conclusion: A 4-week self-administered sound intervention was feasible in outpatients suffering from cancer. Using a panel of 5 questionnaires, passive sound interventions appeared to be more likely to positively influence patient-reported outcomes. In particular, a positive impact was documented in social functioning and fatigue.

【研究目的】癌症仍是对发病率、死亡率及生活质量均造成显著影响的疾病。本前瞻性随机先导研究探讨了声音干预对癌症门诊患者身心健康的影响。【研究方法】本研究采用两种自我实施的声音干预方案：一是借助身体单弦琴开展的主动「音乐演奏」干预，二是佩戴耳机聆听指定音乐合集的被动声音干预。干预持续4周，每晚睡前至少进行15分钟。分别于基线及4周后完成以下自评问卷以评估干预效果：匹兹堡睡眠质量指数（Pittsburgh Sleep Quality Index, PSQI）、欧洲癌症研究与治疗组织（European Organization for Research and Treatment of Cancer, EORTC）生活质量问卷（QLQ-C30）、疼痛与疲劳视觉模拟评分量表（Visual Analogue Scale, VAS），以及疾病进展恐惧（Fear of Progression, FoP）问卷。本探索性试验的主要终点为：统计至少在一个维度出现改善且未出现任何其他维度恶化的患者占比。【研究结果】本研究共纳入73例患者（男性29例，女性44例），按随机分组原则分为主动干预组（n=34，占比47%）与被动干预组（n=39，占比53%）。患者中位年龄为52.0岁（年龄范围21~79岁）。14例患者（19%）自述有音乐活动经历。干预的中位实施天数为26天（范围5~28天）。被动干预组达到主要终点的患者比例更高：被动组为15例（39%），主动组为9例（27%）。在疲劳VAS评分及QLQ-30问卷结果中，可见有利于被动干预组的差异。总体而言，被动干预组有12例患者（31%）的QLQ-30问卷评分得到改善，而主动组仅3例（9%）。根据QLQ-C30问卷结果，被动干预组的社会功能与呼吸短促症状均得到显著改善。作为FoP问卷维度之一的情感反应，在被动干预组中也观察到显著改善。未发现干预对疼痛或睡眠质量存在影响。【研究结论】为期4周的自我实施声音干预在癌症门诊患者中具备可行性。通过5种自评问卷的综合评估，被动声音干预似乎更易对患者报告结局产生积极影响，其中社会功能与疲劳症状的改善尤为显著。