BMC Cancer. 2013 Apr 23;13:201. doi: 10.1186/1471-2407-13-201.
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.
METHODS/DESIGN: 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.
ACTRN12612000404820.
多达 70%的癌症幸存者报告存在明显的癌症复发恐惧（FCR）。尽管 FCR 对心理幸福感和生活质量有已知的负面影响，但很少有研究调查针对高 FCR 的干预措施。我们的团队已经基于自我调节执行功能模型和关联框架理论开发并试点了一种新的干预措施（克服恐惧），并正在一项随机对照试验（RCT）中评估克服恐惧的效果。我们旨在比较克服恐惧干预和放松训练在降低 FCR 影响方面的疗效和成本效益。
方法/设计：这是一项多中心 RCT，共有 260 名参与者被随机分配到克服恐惧干预组或放松训练组。两种干预措施均由具有 5 年以上肿瘤学经验的经过培训的心理学家、精神科医生和社会工作者，在 10 周内分 5 次进行。克服恐惧课程使用注意力训练、超脱的正念、元认知疗法、价值观澄清和心理教育，帮助患者改变调节和应对癌症复发想法的方式。放松训练包括渐进性和被动肌肉放松、冥想放松、可视化和“快速放松”技术的训练。选择放松训练是为了控制治疗师的时间和注意力，并且作为一种干预措施具有良好的表面效度。主要结局是癌症复发恐惧。次要结局包括痛苦、生活质量、未满足的需求和卫生保健利用。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。符合条件的参与者是早期乳腺癌或结直肠癌幸存者，他们在研究入组前 2 个月至 5 年内完成了基于医院的治疗，并且在癌症复发恐惧量表上的得分处于临床范围。生物统计学家对分组分配情况不知情，参与者对正在评估的干预措施不知情。随机分组是通过计算机生成的，按治疗师分层，并使用连续编号的密封信封。
如果成功，该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，并通过更合理地利用随访护理和该庞大人群中的其他卫生服务来降低整体医疗保健成本。
ACTRN12612000404820。
