Conquer fear: protocol of a randomised controlled trial of a psychological intervention to reduce fear of cancer recurrence

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• 作者：Phyllis N Butow (1)
  Melanie L Bell (1)
  Allan B Smith (1)
  Joanna E Fardell (1)
  Belinda Thewes (1)
  Jane Turner (2)
  Jemma Gilchrist (3)
  Jane Beith (4)
  Afaf Girgis (5)
  Louise Sharpe (6)
  Sophy Shih (7)
  Cathrine Mihalopoulos (7)
  
• 关键词：Fear of cancer recurrence ; Cancer ; Oncology ; RCT ; S ; REF model ; Intervention ; Metacognition ; Detached mindfulness
• 刊名：BMC Cancer
• 出版年：2013
• 出版时间：December 2013
• 年：2013
• 卷：13
• 期：1
• 全文大小：237KB
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• 作者单位：Phyllis N Butow (1)
  Melanie L Bell (1)
  Allan B Smith (1)
  Joanna E Fardell (1)
  Belinda Thewes (1)
  Jane Turner (2)
  Jemma Gilchrist (3)
  Jane Beith (4)
  Afaf Girgis (5)
  Louise Sharpe (6)
  Sophy Shih (7)
  Cathrine Mihalopoulos (7)
  
  1. Psycho-Oncology Co-operative Research Group (PoCoG), School of Psychology, The University of Sydney, Sydney, NSW, 2006, Australia
  2. School of Medicine, University of Queensland, Herston, QLD, 4029, Australia
  3. Crown Princess Mary Cancer Centre, Westmead, NSW, 2145, Australia
  4. Royal Prince Alfred Hospital, Camperdown, NSW, 2050, Australia
  5. Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, University of New South Wales, Liverpool, NSW, 2170, Australia
  6. School of Psychology, The University of Sydney, Sydney, NSW, 2006, Australia
  7. Health Economics Unit, Deakin University, Burwood, VIC, 3125, Australia
  
• ISSN：1471-2407

文摘

Background 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. Discussion 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 Trial registration: ACTRN12612000404820