Background: Up to 70% of cancer survivors report clinically significant levels of fear of cancer recurrence (FCR).\r\nDespite the known negative impact of FCR on psychological wellbeing and quality of life, little research has\r\ninvestigated interventions for high FCR. Our team has developed and piloted a novel intervention (Conquer Fear)\r\nbased on the Self-Regulatory Executive Function Model and Relational Frame Theory and is evaluating Conquer\r\nFear in a randomised controlled trial (RCT). We aim to compare the efficacy and cost-efficacy of the Conquer Fear\r\nIntervention and relaxation training in reducing the impact of FCR.\r\nMethods/design: This study is a multi-centre RCT with 260 participants randomised either to the Conquer Fear\r\nIntervention or relaxation training. Both interventions will be delivered in five sessions over 10 weeks by trained\r\npsychologists, psychiatrists and social workers with five or more years experience in oncology. Conquer Fear\r\nsessions use attentional training, detached mindfulness, meta-cognitive therapy, values clarification and\r\npsycho-education to help patients change the way they regulate and respond to thoughts about cancer\r\nrecurrence. Relaxation training includes training in progressive and passive muscle relaxation, meditative relaxation,\r\nvisualisation and ââ?¬Å?quick relaxationââ?¬Â techniques. Relaxation was chosen to control for therapist time and attention\r\nand has good face-validity as an intervention. The primary outcome is fear of cancer recurrence. Secondary\r\noutcomes include distress, quality of life, unmet needs, and health care utilisation. Participants complete\r\nquestionnaires prior to starting the intervention, immediately after completing the intervention, 3 and 6 months\r\nlater. Eligible participants are early-stage breast or colorectal cancer survivors who have completed hospital-based\r\ntreatment between 2 months and 5 years prior to study entry and report a score in the clinical range on the Fear\r\nof Cancer Recurrence Inventory. The biostatistician is blinded to group allocation and participants are blinded to\r\nwhich intervention is being evaluated. Randomisation is computer generated, stratified by therapist, and uses\r\nsequentially numbered sealed envelopes.\r\nDiscussion: If successful, the study will provide an evidence-based intervention to reduce psychological morbidity\r\nin cancer survivors, and reduce overall health care costs due to more appropriate use of follow-up care and other\r\nhealth services in this very large population.
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