Tran Mei Jun, Jefford Michael, Smith Ben, Lynch Fiona, Dhillon Haryana M, Shaw Joanne, McDowell Lachlan, White Alan, Halloran Clare, Wiesenfeld David, Ftanou Maria
Psychosocial Oncology Program, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Australian Cancer Survivorship Centre, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Pilot Feasibility Stud. 2022 Aug 10;8(1):177. doi: 10.1186/s40814-022-01123-y.
Fear of cancer recurrence (FCR) is a significant unmet need amongst cancer survivors and is consistently associated with psychological distress and impaired quality of life. Psychological interventions for FCR, such as ConquerFear, have demonstrated efficacy in reducing FCR and improving emotional wellbeing. Unfortunately, there are barriers to the uptake of evidence-based FCR treatments in clinical practice. A stepped-care FCR treatment model may overcome these barriers and has demonstrated potential in people with advanced melanoma. This study aims to evaluate the acceptability, feasibility, and impact of a stepped-care FCR treatment model (Fear-Less) in people with other cancer types, who have completed treatment with curative intent.
Sixty people with early-stage cancer (defined as individuals who have received treatment with curative intent and with no metastatic disease) will be screened for FCR using the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF). Individuals reporting moderate FCR (FCRI-SF between 13 and 21) will be offered a clinician-guided self-management resource; those reporting high FCR (FCRI-SF ≥ 22) will be offered individual therapy according to the ConquerFear protocol. Participants will complete purpose-built evaluation surveys assessing their FCR screening and intervention experiences. Clinicians will also complete a survey regarding their experiences of the treatment model. Fear-Less will be evaluated in terms of (1) acceptability (i.e., patient and clinician experience), (2) feasibility (i.e., referral uptake, treatment adherence, and time taken to screen and deliver interventions), and (3) impact (i.e., pre- to post-intervention FCR changes).
The Fear-Less stepped-care model is a novel framework for screening FCR and stratifying survivors to the appropriate level of treatment. Our study will provide an indication of whether Fear-Less is a feasible and acceptable FCR model of care amongst survivors with early-stage disease and inform further investigations of this model.
Australian New Zealand Clinical Trials Registry (ANZCTR); ACTRN12622000818730 .
癌症复发恐惧（FCR）是癌症幸存者中一项尚未得到充分满足的重大需求，且一直与心理困扰和生活质量受损相关。针对FCR的心理干预措施，如“战胜恐惧”，已证明在减轻FCR和改善情绪健康方面具有疗效。不幸的是，在临床实践中，循证FCR治疗的采用存在障碍。一种逐步护理的FCR治疗模式可能会克服这些障碍，并且已在晚期黑色素瘤患者中显示出潜力。本研究旨在评估一种逐步护理的FCR治疗模式（“无畏”）在已完成根治性治疗的其他癌症类型患者中的可接受性、可行性和影响。
将使用癌症复发恐惧量表简表（FCRI-SF）对60名早期癌症患者（定义为已接受根治性治疗且无转移性疾病的个体）进行FCR筛查。报告中度FCR（FCRI-SF在13至21之间）的个体将获得临床医生指导的自我管理资源；报告高度FCR（FCRI-SF≥22）的个体将根据“战胜恐惧”方案接受个体治疗。参与者将完成专门设计的评估调查，评估他们的FCR筛查和干预经历。临床医生也将完成一项关于他们对治疗模式体验的调查。将从以下方面评估“无畏”模式：（1）可接受性（即患者和临床医生的体验），（2）可行性（即转诊接受情况、治疗依从性以及筛查和提供干预措施所需的时间），以及（3）影响（即干预前后FCR的变化）。
“无畏”逐步护理模式是一种用于筛查FCR并将幸存者分层至适当治疗水平的新颖框架。我们的研究将表明“无畏”模式在早期疾病幸存者中是否是一种可行且可接受的FCR护理模式，并为该模式的进一步研究提供信息。
澳大利亚新西兰临床试验注册中心（ANZCTR）；ACTRN12622000818730 。
