Psychoeducational and rehabilitative intervention to manage cancer cachexia (PRICC) for patients and their caregivers: protocol for a single-arm feasibility trial.
Psychoeducational and rehabilitative intervention to manage cancer cachexia (PRICC) for patients and their caregivers: protocol for a single-arm feasibility trial.
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针对癌症患者及其照顾者的癌症恶病质心理教育和康复干预（PRICC）：一项单臂可行性试验方案
DOI：
10.1136/bmjopen-2020-042883
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发表时间：
2021-03-01
期刊：
影响因子：
2.9
通讯作者：
Tanzi S
中科院分区：
文献类型：
--
作者：
Buonaccorso L;Bertocchi E;Autelitano C;Allisen Accogli M;Denti M;Fugazzaro S;Martucci G;Costi S;Tanzi S
半数癌症患者会经历恶病质，在生命的最后几周，患病率会上升到80%以上。癌症恶病质（CC）是一种复杂的相关体验，涉及患者 - 家属二元关系。目前尚无关于二元关系的心理教育部分和康复部分之间关联的研究，以支持在癌症恶病质管理中建立更具功能性的关系。
本研究的主要目的是评估对二元关系进行心理教育干预与康复干预相结合的可行性。
次要目的是提高生活质量（QoL）以及干预的可接受性。
这项采用非药物干预前瞻性的混合方法研究包括30名连续的患有恶病质和难治性恶病质的癌症患者及其照顾者，由专业姑息治疗团队提供协助。招募将持续1年。干预包括两个部分：（1）心理教育干预：二元关系主体与受过培训的护士每周进行3次面对面咨询，以帮助二元关系主体应对非自愿性体重减轻并强化二元应对资源；（2）康复干预：二元关系主体与受过培训的物理治疗师每两周进行3次教育课程，重点是自我管理、目标设定和身体活动，每周还有3次家庭锻炼课程。
主要终点将是对干预的依从性，以两个部分的完成水平大于或等于50%来表示。次要终点将是生活质量（厌食 - 恶病质治疗功能评估）、照顾者负担（扎里特负担量表）、身体机能（握力和30秒坐 - 立测试）以及干预的可接受性（对二元关系主体和医疗专业人员进行的临时半结构化访谈）。
该研究已获得意大利雷焦艾米利亚大区瓦斯特 - 艾米利亚北部伦理委员会（Azienda USL - IRCSS Reggio Emilia）批准，编号：73/2019/SPER/IRCCSRE。作者将通过在国际科学期刊上发表来传播研究结果。
NCT04153019。
Half of all patients with cancer experience cachexia, with the prevalence rising above 80% in the last weeks of life. Cancer cachexia (CC) is a complex relational experience that involves the patient–family dyad. There are no studies on the association between the psychoeducational component and the rehabilitative component of dyads for supporting more functional relationships in the management of CC. The primary objective of this study is to evaluate the feasibility of a psychoeducational intervention combined with a rehabilitative intervention on dyads. The secondary objective is to improve the quality of life (QoL) and acceptability of the intervention. This mixed-methods study with a nonpharmacological interventional prospective includes 30 consecutive cancer patients with cachexia and refractory cachexia and their caregivers, assisted by the Specialised Palliative Care Team. The recruitment will last 1 year. The intervention involves two components: (1) psychoeducational intervention: 3 weekly face-to-face consultations between dyads and trained nurses to help the dyads cope with involuntary weight loss and strengthening dyadic coping resources and (2) rehabilitation intervention: 3 biweekly educational sessions between dyads and trained physiotherapists focused on self-management, goal-setting, physical activity with three home exercise sessions per week. The primary endpoint will be in adherence to the intervention, indicated by a level of completion greater than or equal to 50% in both components. The secondary endpoints will be QoL (Functional Assessment of Anorexia-Cachexia Therapy), caregiver burden (Zarit Burden), physical performance (Hand-Grip strength and 30 seconds sit-to-stand test), and the acceptability of the intervention (ad hoc semi-structured interviews with the dyads and the healthcare professionals). The study was approved by the Ethics Committee Area Vasta Emilia Nord, Azienda USL-IRCSS Reggio Emilia, Italy, number: 73/2019/SPER/IRCCSRE. The authors will provide the dissemination of the results through publication in international scientific journals. NCT04153019.
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