一项针对新诊断的晚期癌症患者的个体化、多学科姑息性康复的平行组随机临床试验：Pal-Rehab研究方案。
A parallel-group randomized clinical trial of individually tailored, multidisciplinary, palliative rehabilitation for patients with newly diagnosed advanced cancer: the Pal-Rehab study protocol.
作者信息
Nottelmann Lise, Groenvold Mogens, Vejlgaard Tove Bahn, Petersen Morten Aagaard, Jensen Lars Henrik
机构信息
Department of Oncology, Palliative Team, Vejle Hospital, Beriderbakken 4, 7100, Vejle, Denmark.
Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark.
出版信息
BMC Cancer. 2017 Aug 23;17(1):560. doi: 10.1186/s12885-017-3558-0.
BACKGROUND
The effect of early palliative care and rehabilitation on the quality of life of patients with advanced cancer has been only sparsely described and needs further investigation. In the present trial we combine elements of early, specialized palliative care with cancer rehabilitation in a 12-week individually tailored, palliative rehabilitation program initiated shortly after a diagnosis of advanced cancer.
METHODS
This single center, randomized, controlled trial will include 300 patients with newly diagnosed advanced cancer recruited from the Department of Oncology, Vejle Hospital. The patients are randomized to a specialized palliative rehabilitation intervention integrated in standard oncology care or to standard oncology care alone. The intervention consists of a multidisciplinary group program, individual consultations, or a combination of both. At baseline and after six and 12 weeks the patients will be asked to fill out questionnaires on symptoms, quality of life, and symptoms of depression and anxiety. Among the symptoms and problems assessed, patients are asked to indicate the problem they need help with to the largest extent. The effect of the intervention on this problem is the primary outcome measure of the study. Secondary outcome measures include survival and economic consequences.
DISCUSSION
To our knowledge the Pal-Rehab study is the first randomized, controlled, phase III trial to evaluate individually tailored, palliative rehabilitation in standard oncology care initiated shortly after an advanced cancer diagnosis. The study will contribute with evidence on the effectiveness of implementing early palliative care in standard oncology treatment and hopefully offer new knowledge and future directions as to the content of palliative rehabilitation programs.
TRIAL REGISTRATION
Clinicaltrials.gov Identifier: NCT02332317 , registered retrospectively on December 30, 2014. One study participant had been enrolled at the time.
背景
早期姑息治疗和康复对晚期癌症患者生活质量的影响鲜有描述，需要进一步研究。在本试验中，我们将早期、专业化的姑息治疗要素与癌症康复相结合，开展了一项为期12周的针对晚期癌症诊断后不久启动的个体化姑息康复项目。
方法
这项单中心、随机、对照试验将纳入从维杰勒医院肿瘤科招募的300例新诊断的晚期癌症患者。患者被随机分为接受整合在标准肿瘤治疗中的专业化姑息康复干预组或仅接受标准肿瘤治疗组。干预措施包括多学科小组项目、个体咨询或两者结合。在基线以及6周和12周后，将要求患者填写关于症状、生活质量以及抑郁和焦虑症状的问卷。在评估的症状和问题中，要求患者指出他们最需要帮助解决的问题。干预对该问题的影响是本研究的主要结局指标。次要结局指标包括生存情况和经济后果。
讨论
据我们所知，Pal-Rehab研究是第一项随机、对照的III期试验，旨在评估在晚期癌症诊断后不久启动的标准肿瘤治疗中个体化的姑息康复。该研究将为在标准肿瘤治疗中实施早期姑息治疗的有效性提供证据，并有望就姑息康复项目的内容提供新知识和未来方向。
试验注册
Clinicaltrials.gov标识符：NCT02332317，于2014年12月30日追溯注册。当时已有一名研究参与者入组。
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