Bergholdt Stinne Holm, Larsen Pia Veldt, Kragstrup Jakob, Søndergaard Jens, Hansen Dorte Gilså
National Research Centre for Cancer Rehabilitation, Research Unit of General Practice, University of Southern Denmark, Odense, Denmark.
BMJ Open. 2012 Apr 16;2(2):e000764. doi: 10.1136/bmjopen-2011-000764. Print 2012.
To test the hypothesis that a multimodal intervention giving the general practitioner (GP) an enhanced role in cancer rehabilitation improves patients' health-related quality of life and psychological distress.
Cluster randomised controlled trial. All general practices in Denmark were randomised to an intervention group or to a control group. Patients were subsequently allocated to intervention or control (usual procedures) based on the randomisation status of their GP.
All clinical departments at a public regional hospital treating cancer patients and all general practices in Denmark.
Adult patients treated for incident cancer at Vejle Hospital, Denmark, between 12 May 2008 and 28 February 2009. A total of 955 patients (486 to the intervention group and 469 to the control group) registered with 323 general practices were included.
The intervention included an interview about rehabilitation needs with a rehabilitation coordinator at the regional hospital, information from the hospital to the GP about individual needs for rehabilitation and an encouragement of the GP to contact the patient to offer his support with rehabilitation.
The primary outcome was health-related quality of life measured 6 months after inclusion using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Secondary outcomes included quality of life at 14 months and additional subscales of the EORTC QLQ-C30 at 6 and 14 months and psychological distress at 14 months using the Profile of Mood States Scale.
No effect of the intervention was observed on primary and/or secondary outcomes after 6 and 14 months.
A multimodal intervention aiming to give the GP an enhanced role in cancer patients' rehabilitation did not improve quality of life or psychological distress.
ClinicalTrials.gov, registration ID number NCT01021371.
检验以下假设，即给予全科医生（GP）在癌症康复中更大作用的多模式干预可改善患者的健康相关生活质量和心理困扰。
整群随机对照试验。丹麦所有的全科医疗诊所被随机分为干预组或对照组。随后根据其全科医生的随机分组情况，将患者分配至干预组或对照组（常规程序）。
丹麦一家公立地区医院治疗癌症患者的所有临床科室以及丹麦所有的全科医疗诊所。
2008年5月12日至2009年2月28日期间在丹麦韦勒医院接受新发癌症治疗的成年患者。共有955名在323家全科医疗诊所登记的患者被纳入研究（486名进入干预组，469名进入对照组）。
干预包括与地区医院的康复协调员进行一次关于康复需求的访谈、医院向全科医生提供关于个体康复需求的信息以及鼓励全科医生联系患者以提供康复支持。
主要结局是在入组6个月后使用欧洲癌症研究与治疗组织生活质量问卷核心30（EORTC QLQ-C30）测量的健康相关生活质量。次要结局包括14个月时的生活质量、6个月和14个月时EORTC QLQ-C30的其他子量表以及14个月时使用情绪状态剖面图量表测量的心理困扰。
在6个月和14个月后，未观察到干预对主要和/或次要结局有任何影响。
旨在使全科医生在癌症患者康复中发挥更大作用的多模式干预并未改善生活质量或心理困扰。
ClinicalTrials.gov，注册ID号NCT01021371。
