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

Butow, Phyllis N., Bell, Melanie L., Smith, Allan B., Fardell, Joanna E., Thewes, Belinda, Turner, Jane, Gilchrist, Jemma, Beith, Jane, Girgis, Afaf, Sharpe, Louise, Shih, Sophy, Mihalopoulos, Cathrine and Conquer Fear Authorship Group (2013) Conquer fear: protocol of a randomised controlled trial of a psychological intervention to reduce fear of cancer recurrence. BMC Cancer, 13 201.1-201.10. doi:10.1186/1471-2407-13-201


Author Butow, Phyllis N.
Bell, Melanie L.
Smith, Allan B.
Fardell, Joanna E.
Thewes, Belinda
Turner, Jane
Gilchrist, Jemma
Beith, Jane
Girgis, Afaf
Sharpe, Louise
Shih, Sophy
Mihalopoulos, Cathrine
Conquer Fear Authorship Group
Title Conquer fear: protocol of a randomised controlled trial of a psychological intervention to reduce fear of cancer recurrence
Journal name BMC Cancer   Check publisher's open access policy
ISSN 1471-2407
Publication date 2013-04-01
Year available 2013
Sub-type Article (original research)
DOI 10.1186/1471-2407-13-201
Open Access Status DOI
Volume 13
Start page 201.1
End page 201.10
Total pages 10
Place of publication London, United Kingdom
Publisher BioMed Central
Language eng
Formatted abstract
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.
Keyword Fear of cancer recurrence
Cancer
Oncology
RCT
S-REF model
Intervention
Metacognition
Detached mindfulness
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2014 Collection
School of Medicine Publications
 
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