Abstract
BackgroundUp 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/designThis 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.DiscussionIf 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 registrationTrial registration: ACTRN12612000404820
Highlights
Up to 70% of cancer survivors report clinically significant levels of fear of cancer recurrence (FCR)
The report was critical of the paucity of intervention research to address the psychosocial consequences of cancer and its treatments, and stated that “addressing survivors’ unmet needs and providing greater clarity around follow-up is likely to lead to significant efficiencies in health care delivery and potential cost savings.” [3]
One of the most prevalent unmet needs in survivors is for help with fear of cancer recurrence (FCR), defined as the fear that cancer could return or progress in the same place or another part of the body [4]
Summary
Theoretical significance This RCT advances the field by representing the first controlled trial of a novel, evidence-based and theoreticallybased model of psychological support for cancer survivors with high FCR. Clinical significance The Conquer Fear intervention aligns with emerging priorities in survivorship care in cancer which identify promotion of quality of life and maximizing well-being and optimal participation in social and occupational roles as central to care, rather than the traditional surveillancebased approach to follow-up which focuses on identification of new disease or late complications of cancer treatment. It is in line with consumer priorities for survivorship research [64]. All authors were involved in drafting the manuscript and have read and approved the final manuscript
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