Conquer fear: protocol of a randomised controlled trial of a psychological intervention to reduce fear of cancer recurrence.
Conquer fear: protocol of a randomised controlled trial of a psychological intervention to reduce fear of cancer recurrence.
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DOI：
10.1186/1471-2407-13-201
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发表时间：
2013-04-23
期刊：
影响因子：
3.8
通讯作者：
members of the Conquer Fear Authorship Group
中科院分区：
文献类型：
--
作者：
Butow PN;Bell ML;Smith AB;Fardell JE;Thewes B;Turner J;Gilchrist J;Beith J;Girgis A;Sharpe L;Shih S;Mihalopoulos C;members of the Conquer Fear Authorship Group
高达70%的癌症幸存者报告了临床上显著的癌症复发恐惧(FCR)。尽管已知FCR对心理健康和生活质量的负面影响，但很少有研究调查高FCR的干预措施。我们的团队基于自我调节执行功能模型和关系框架理论开发并试验了一种新的干预措施(征服恐惧)，并正在通过随机对照试验(RCT)评估征服恐惧。我们的目的是比较征服恐惧干预和放松训练在减少FCR影响方面的效果和成本效益。这项研究是一项多中心随机对照试验，260名参与者被随机分为征服恐惧干预组或放松训练组。这两种干预措施都将由训练有素的心理学家、精神病学家和具有五年或五年以上肿瘤学经验的社会工作者在10周内分五次进行。征服恐惧会议使用注意力训练、超然正念、元认知疗法、价值澄清和心理教育来帮助患者改变他们调节和应对癌症复发的想法的方式。放松训练包括渐进式和被动肌肉放松训练、冥想放松训练、视觉化训练和“快速放松”技巧。选择放松来控制治疗师的时间和注意力，作为一种干预具有良好的表面效度。主要结果是对癌症复发的恐惧。次要结果包括痛苦、生活质量、未得到满足的需求和卫生保健利用率。参与者在开始干预前、干预完成后立即、3个月和6个月后完成问卷调查。符合条件的参与者是早期乳腺癌或结直肠癌幸存者，他们在进入研究前两个月至五年内完成了以医院为基础的治疗，并在癌症复发恐惧问卷的临床范围内报告了分数。生物统计学家对分组分配视而不见，参与者对正在评估的干预措施视而不见。随机化是由计算机生成的，由治疗师分层，并使用顺序编号的密封信封。如果成功，这项研究将提供一种基于证据的干预措施，以减少癌症幸存者的心理发病率，并由于在这一庞大的人口中更适当地使用后续护理和其他卫生服务，从而降低总体卫生保健成本。试用登记：ACTRN12612000404820
Up to 70% of cancer survivors report clinically significant levels of fear of cancer recurrence (FCR). Despite the known negative impact of FCR on psychological wellbeing and quality of life, little research has investigated interventions for high FCR. Our team has developed and piloted a novel intervention (Conquer Fear) based on the Self-Regulatory Executive Function Model and Relational Frame Theory and is evaluating Conquer Fear in a randomised controlled trial (RCT). We aim to compare the efficacy and cost-efficacy of the Conquer Fear Intervention and relaxation training in reducing the impact of FCR. This study is a multi-centre RCT with 260 participants randomised either to the Conquer Fear Intervention or relaxation training. Both interventions will be delivered in five sessions over 10 weeks by trained psychologists, psychiatrists and social workers with five or more years experience in oncology. Conquer Fear sessions use attentional training, detached mindfulness, meta-cognitive therapy, values clarification and psycho-education to help patients change the way they regulate and respond to thoughts about cancer recurrence. Relaxation training includes training in progressive and passive muscle relaxation, meditative relaxation, visualisation and “quick relaxation” techniques. Relaxation was chosen to control for therapist time and attention and has good face-validity as an intervention. The primary outcome is fear of cancer recurrence. Secondary outcomes include distress, quality of life, unmet needs, and health care utilisation. Participants complete questionnaires prior to starting the intervention, immediately after completing the intervention, 3 and 6 months later. Eligible participants are early-stage breast or colorectal cancer survivors who have completed hospital-based treatment between 2 months and 5 years prior to study entry and report a score in the clinical range on the Fear of Cancer Recurrence Inventory. The biostatistician is blinded to group allocation and participants are blinded to which intervention is being evaluated. Randomisation is computer generated, stratified by therapist, and uses sequentially numbered sealed envelopes. If successful, the study will provide an evidence-based intervention to reduce psychological morbidity in cancer survivors, and reduce overall health care costs due to more appropriate use of follow-up care and other health services in this very large population. Trial registration: ACTRN12612000404820
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影响因子：
7.6
作者：
BARON, RM;KENNY, DA
通讯作者：
KENNY, DA
影响因子：
7.2
作者：
Adams, G;Gulliford, MC;Campbell, MJ
通讯作者：
Campbell, MJ
影响因子：
3.1
作者：
Campbell, H. Sharon;Sanson-Fisher, Rob;Taylor-Brown, Jill
通讯作者：
Taylor-Brown, Jill
DOI：
10.1016/s0936-6555(97)80055-6
发表时间：
1997-01-01
期刊：
Clinical oncology (Royal College of Radiologists (Great Britain))
影响因子：
--
作者：
Glynne-Jones, R;Chait, I;Thomas, S F
通讯作者：
Thomas, S F
影响因子：
3.9
作者：
Hatcher, RL;Gillaspy, JA
通讯作者：
Gillaspy, JA