Department of Health, Faculty of Health Sciences, Tsukuba University of Technology, 4-12-7 Kasuga, Tsukuba, Ibaraki, 305-8521, Japan.
Trials. 2013 Jul 24;14:233. doi: 10.1186/1745-6215-14-233.
Cancer patients and survivors regularly feel anxious about cancer recurrence or death, even after the conclusion of medical treatment, and they are often highly physiologically and psychologically stressed. Massage therapy is one of the most widely used complementary and alternative therapies used in the hope of alleviating such stress and physical and psychological complaints and to improve health-related quality of life. This randomized phase III, two-armed, parallel group, clinical trial was designed after obtaining positive findings in a preliminary study. The primary objective is to verify the effects of continuous Japanese massage therapy, referred to as Anma therapy, for cancer survivors. The secondary objective is to confirm the immediate effects of a single Anma massage session for cancer survivors.
METHODS/DESIGN: Sixty cancer survivors older than 20 years of age who have had histologically confirmed uterine cervical, endometrial, ovarian, fallopian tube or peritoneal cancer in the past, but with no recurrence for more than 3 years since receiving standard medical treatment, are being recruited by gynecologists in medical facilities. In the coordinating office, they are randomly allocated to two groups (n = 30 each): an Anma massage group receiving a 40-min Anma massage session once weekly over a 2-month intervention period (total of eight Anma massage sessions) and a control group being followed by medical doctors and receiving no Anma massage sessions. The primary end point is the severity of physical subjective symptoms that cancer survivors report in daily life, assessed using a Visual Analogue Scale. Secondary end points are urine and saliva analyses, psychological condition and health-related quality-of-life scores as determined on the basis of a self-report questionnaire.
Using the evidence-based findings of this trial, medical professionals should be able to explain the benefits conferred by Anma massage to cancer survivors and provide higher-quality information to better inform patients regarding their decisions about whether to receive such therapy.
This trial is registered with the UMIN Clinical Trials Registry as UMIN000009097.
癌症患者和幸存者在治疗结束后经常会感到焦虑，担心癌症复发或死亡，他们通常承受着高度的生理和心理压力。按摩疗法是最广泛使用的补充和替代疗法之一，希望能缓解这种压力以及身体和心理上的不适，并提高与健康相关的生活质量。本研究是在一项初步研究获得阳性结果后设计的一项随机 III 期、双臂、平行组临床试验。主要目的是验证连续日式按摩疗法（简称 Anma 疗法）对癌症幸存者的疗效。次要目的是确认单次 Anma 按摩对癌症幸存者的即时疗效。
方法/设计：招募 60 名年龄在 20 岁以上的癌症幸存者，他们过去曾被确诊患有组织学证实的子宫颈、子宫内膜、卵巢、输卵管或腹膜癌，但在接受标准治疗后 3 年以上无复发。由医疗机构的妇科医生进行招募。在协调办公室，他们被随机分配到两组（每组 30 人）：Anma 按摩组接受每周一次、每次 40 分钟的 Anma 按摩，共 2 个月（共 8 次 Anma 按摩）；对照组由医生随访，不接受 Anma 按摩。主要终点是癌症幸存者在日常生活中报告的身体主观症状的严重程度，采用视觉模拟评分法进行评估。次要终点是尿和唾液分析、心理状况和基于自我报告问卷的健康相关生活质量评分。
本试验的证据将有助于医疗专业人员向癌症幸存者解释 Anma 按摩的益处，并提供更高质量的信息，使患者更好地了解他们是否选择接受这种治疗。
本试验已在 UMIN 临床试验注册中心注册，注册号为 UMIN000009097。
