Oral Presentation Joint 2016 COSA and ANZBCTG Annual Scientific Meeting

A randomised controlled trial (RCT) of a psychological intervention (Conquer Fear) to reduce clinical levels of fear of cancer recurrence in breast, colorectal and melanoma cancer survivors (#101)

Phyllis Butow 1 , Belinda Thewes 1 2 , Louise Sharpe 3 , Jane Turner 4 , Jemma Gilchrist 5 , Afaf Girgis 6 , Allan Smith 3 6 , Joanna Fardell 7 8 , Stephanie Tesson 1 , Jane Beith 9 , Rebecca Asher 10 , Members of the Conquer Fear Authorship Group 1
  1. Psycho-Oncology Co-operative Research Group (PoCoG), School of Psychology, The University of Sydney, Sydney, NSW, Australia
  2. Department of Medical Psychology, Radboud University Medical Centre, 6500 HB Nijmegen, The Netherlands
  3. School of Psychology, The University of Sydney, Sydney, NSW, Australia
  4. Mental Health Centre, School of Medicine, University of Queensland, Herston, QLD, Australia
  5. Crown Princess Mary Cancer Centre, Westmead Hospital, Westmead, NSW, Australia
  6. Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, University of New South Wales, Liverpool, NSW, Australia
  7. Discipline of Paediatrics, School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Randwick, NSW, Australia
  8. Behavioural Sciences Unit, Kids Cancer Centre, Sydney Children's Hospital, Randwick, NSW, Australia
  9. Medical Oncology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia
  10. Biostatistics, NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW , Australia

Aims: Clinically significant fear of cancer recurrence (FCR) is common in cancer survivors, and associated with impaired quality of life (QOL) and increased healthcare usage. Using a parallel randomised controlled trial, the Conquer Fear study aimed to evaluate the impact of a theoretically-based psychological intervention in cancer survivors with clinical FCR. 

Methods: Participants were disease-free Stage 0-III breast, Dukes A-C colorectal or Stage IA-IIB melanoma cancer survivors, 2 months to 5 years post-treatment, who scored above clinical cut-off (≥13) on the FCR Inventory severity subscale. Patients were randomized to: the Conquer Fear intervention (attention training, detached mindfulness, metacognitive therapy, values clarification and psycho-education), or the control intervention (relaxation training). Both interventions comprised 5 sessions, delivered by 26 therapists at 20 sites Australia-wide. Assessments were conducted at baseline, post-treatment, 3 and 6 months later. Independent samples t-tests evaluated differences in change scores between intervention and control arms for FCR (primary outcome), and secondary psychological outcomes using an intention-to-treat analysis. Target recruitment was 260 participants.

Results: Of 305 eligible and contactable patients, 222 agreed and were randomized. The groups were well matched at baseline. Participants were on average 52 years old (SD=10.1), 28 months since treatment completion, and most had breast cancer (84%). At post-treatment, intervention group participants reported an 18.1-point decrease in total FCR compared to a 7.6-point decrease in control participants (p=.0003, 95%CI -16.1, -4.9; Cohen’s d=0.44, range 0-168) and a 4.7-point decrease in the FCR severity subscale compared to a 2.4-point decrease in controls (p<.001, 95% CI -3.7, -1.0; Cohen’s d=0.40, range 0-36). Results for secondary outcomes and adjusted analyses will be presented.

Conclusions: This evidence-based psychological intervention was effective in reducing FCR in cancer survivors compared to a control treatment. The next steps will be to assess formats to increase accessibility and cost-efficacy.