大肠癌和心理健康是两个让人极不舒服的话题，但两者都不应该有羞耻感或污名。 

这个月Maia和Manju讨论了促进在应对结肠直肠癌时照顾自己心理健康的临床试验。下面的试验涵盖了从使用老式的纸笔到虚拟现实再到正念。

Maia，有哪些临床试验可以帮助人们在接受或已经接受结肠直肠癌治疗时感到压力减轻或疼痛缓解？

Virtual Trial to Compare Two Digital Therapeutics as Interventions for Physical and Mental Health in People with Cancer (RESTORE) (NCT05227898)

This trial is for stage I through stage III cancer patients with elevated anxiety symptoms. It is for those who are receiving systemic treatment or have received it within the past six months. Eligible patients from anywhere in the United States can enroll in it, since it is a virtual study – they will participate from home, without having to visit a clinic.

During 12 weeks, patients will receive access to one of the two apps, on their smartphone or tablet, and use it to complete 10 informational sessions, each approximately 60 minutes in length. The app also includes guided exercises and other interactive opportunities.

Expressive Writing for the Management of Stress in Cancer Survivors (NCT04776941)

MD安德森的这项临床试验评估了表达性写作（EW）对癌症幸存者压力管理的效果。这是一项虚拟研究，招募在过去三年内被诊断为任何类型癌症的成年人。这些参与者必须能够用英语交谈和阅读，并且能够使用电脑或智能手机与互联网连接。

All of the patients complete questionnaires (which take more than 30 minutes) about their mood, health, and income at the start of the study, and at one, three, and six months. Half of the patients read brief neutral messages and write essays about neutral topics over 30 minutes (nonstop) once weekly, for three weeks. The other half of the patients read brief messages with positive content and write essays, too, in the same conditions, but about their own experiences. Previous clinical trials support the use of expressive writing to improve quality of life in breast cancer survivors and favored improvements in cancer-related symptoms and fatigue levels in renal cell carcinoma. The current study investigates the effect of expressive writing specifically related to stress and aims to find out if this approach is equally effective as virtual, not in-person intervention. The researchers observe that the stress that most cancer survivors face “can be further exacerbated by social upheavals, such as the COVID-19 pandemic. For safety reasons, many patients are isolated with restricted access to in-person health care and reduced social interaction with family and friends. Together, with the economic uncertainties that come with this pandemic, these factors are likely to increase cancer survivors' stress levels. Expressive writing may provide a medium through which cancer survivors confront stressors and find meaning in their experience.”

Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes (NCT04907643)

虽然列出的第一个试验主要涉及纸和笔，是一种真正的低技术干预，但雪松-西奈医学中心（加利福尼亚州洛杉矶）的这项研究评估了一种新技术，即虚拟现实（VR），如何帮助患者管理胃肠道（GI）癌症疼痛。

遭遇严重的腹痛对许多癌症患者的身体、情感和社会功能以及整体生活质量产生了负面影响。VR的治疗性使用已经成为一种有前途的、基于证据的癌症疼痛管理的治疗方式。VR的使用者戴着一副护目镜，眼睛前有一个近距离的屏幕，创造出一种被传送到栩栩如生的三维世界的感觉。迄今为止，VR只限于针对癌症疼痛的短期临床试验。此外，对基于理论的VR模式的研究也很有限，除了单纯的分散注意力。

以有效改善生活质量/缓解疼痛为目标，本研究将测量患者报告的结果（PROs）和三组用户的阿片类药物使用情况。

所有参与者都将获得一个VR视听头盔，该头盔配有方向追踪控制器，支持三自由度（3DOF）头部追踪，拥有一流的光学设备和宽广的视野。它不需要智能手机或个人电脑来操作。参与者将被要求每天积极使用该耳机四周，并遵循其指定的干预措施的具体说明：1.沉浸式技能型VR治疗；2.沉浸式分散注意力的VR治疗；以及3.使用非沉浸式假VR的非沉浸式治疗。非沉浸式假性VR，使用VR头盔中显示的2D视频。

基于技能的治疗将使用虚拟治疗环境来教病人冥想、呼吸练习和疼痛管理。分散注意力的治疗将使用沉浸式视频，旨在让人忘记疼痛。假性VR将使用VR护目镜，但患者将只观看2D视频，而不是3D的沉浸式体验。

曼珠，这个月你想和我们分享什么有趣的心理健康临床试验？

Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers (NCT04870788)

This 60 participant interventional clinical trial conducted at the MD Anderson Cancer Center develops effective and appropriate mindfulness-based interventions that help meet the needs of Latino cancer patients and their family caregivers. Mindfulness-based interventions focus on building awareness of thoughts, emotions/feelings, and sensations. This study may help improve mental well-being and reduce stress and anxiety associated with having cancer or with a family member's cancer diagnosis. The primary objectives of the trial are to adapt a mindfulness-based intervention to improve psychological well-being in Latino patients with advanced cancer and their family caregivers, and to evaluate its feasibility in Latino patient-family caregiver dyads. The secondary objectives are to find out the effects of the adapted mindfulness techniques on patient and caregiver psychological distress, quality of life, and patient cancer symptoms, compared to a waitlist control.

在这项研究中，III期或IV期实体瘤患者和他们的护理人员将被随机分为两组中的一组。在第一组中，患者和照顾者将接受每周60分钟的正念辅导，为期4周。在第二组中，患者和他们的照顾者将在研究开始后的12周内接受每周60分钟的正念辅导，为期4周。参与者在6周和12周时得到一个生活质量评估和一份问卷调查。

Psychotherapy Intervention for Latinos With Adv Cancer (NCT04537936)

这项285人参与的研究的目的是调整一种名为 "以意义为中心的心理治疗 "的咨询干预措施，使其与拉美人的文化相关。这项研究将试图了解影响拉丁裔患者生活质量的因素以及如何改善生活质量。拉美裔常常因癌症而经历更大的挑战，然而很少有研究和干预措施关注这一群体的病人。

这个项目有五个阶段。在第一阶段和第二阶段，研究小组将致力于了解拉丁裔晚期癌症患者的意义、希望、遗产和身份的来源，并向被诊断为晚期癌症的拉丁裔探索意义中心心理疗法。患者将从纪念斯隆-凯特琳癌症中心（MSKCC）和林肯医疗和心理健康中心（LMC）招募，这是一家位于拉丁裔密集地区的公立医院。符合条件的癌症患者还将通过Gany博士的MSKCC的移民健康和癌症差异服务的综合癌症护理访问网络（ICCAN）进行招募。ICCAN使用双语访问促进者来协助病人确定他们的需求。

在第三阶段，将对心理健康服务提供者进行访谈，以了解还有哪些方面可能对病人有帮助。第四阶段将包括病人访谈，了解病人的反馈。第五阶段是随机试点研究，将收集关于招募的可行性、保留率、依从性、干预内容的可接受性和关键结果的初步数据。这一部分将包括60名讲西班牙语的晚期癌症患者入组，并随机分配到干预组或对照组，也就是强化的常规护理组。

主要结果是对精神健康的测量，次要结果包括对抑郁、焦虑、无望和生活质量的测量。

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每月一次，Maia和Manju将花时间为我们的社区解读重要的研究试验、技巧和建议。请务必订阅 报名 with Fight CRC and join COLONTOWN’s online community to continue receiving the most relevant updates in the CRC world!

你也可以关注Maia (@sassycell) 和 Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov for more information on trials.

临床试验 对找到治愈结直肠癌的方法至关重要。作为一个致力于支持病人、护理人员和家庭社区并赋予其权力的宣传组织，抗击大肠癌协会已与下列机构合作 COLONTOWN to deliver a monthly blog series highlighting everything patients need to know about clinical trials and the best treatment options available.  In this series, we hope to cover promising trials that are enrolling, lessons learned from past research, logistics and resources to joining a clinical trial, and provide relevant and timely updates for our colon and rectal cancer community.