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

BMC Cancer

Phyllis N Butow⁵  Melanie L Bell⁵  Allan B Smith⁵  Joanna E Fardell⁵  Belinda Thewes⁵  Jane Turner⁶  Jemma Gilchrist¹  Jane Beith⁴  Afaf Girgis⁷  Louise Sharpe³  Sophy Shih²  Cathrine Mihalopoulos²  members of the Conquer Fear Authorship Group⁵ 

[1] Crown Princess Mary Cancer Centre, Westmead, NSW, 2145, Australia

[2] Health Economics Unit, Deakin University, Burwood, VIC, 3125, Australia

[3] School of Psychology, The University of Sydney, Sydney, NSW, 2006, Australia

[4] Royal Prince Alfred Hospital, Camperdown, NSW, 2050, Australia

[5] Psycho-Oncology Co-operative Research Group (PoCoG), School of Psychology, The University of Sydney, Sydney, NSW, 2006, Australia

[6] School of Medicine, University of Queensland, Herston, QLD, 4029, Australia

[7] Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, University of New South Wales, Liverpool, NSW, 2170, Australia

关键词: Detached mindfulness;    Metacognition;    Intervention;    S-REF model;    RCT;    Oncology;    Cancer;    Fear of cancer recurrence;   

Others  :  1079790
DOI  :  10.1186/1471-2407-13-201

 received in 2013-03-13, accepted in 2013-03-26,  发布年份 2013

【 摘 要 】

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

【 授权许可】

   
2013 Butow et al.; licensee BioMed Central Ltd.

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