Long-term results of a phase II randomized 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.

Authors

null

Jane McNeil Beith

Chris O'Brien Lifehouse, Camperdown, Australia

Jane McNeil Beith , Belinda Thewes , Jane Turner , Jemma Gilchrist , Louise Sharpe , Afaf Girgis , Allan 'Ben' Smith , Joanna Fardell , Stephanie Tesson , Rachel O'Connell , Rebecca Asher , Phyllis Butow

Organizations

Chris O'Brien Lifehouse, Camperdown, Australia, School of Psychology, The University of Sydney, Sydney, Australia, Mental Health Centre, School of Medicine, University of Queensland, Brisbane, Australia, Crown Princess Mary Cancer Centre Westmead, Westmead, Australia, Centre for Oncology Education and Research Translation (CONCERT), Sydney, Australia, Behavioural Sciences Unit, School of Women's and Children's Health, University of New South Wales, Sydney, Australia, Psycho-Oncology Co-operative Research Group (PoCoG), University of Sydney, Sydney, Australia, NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia

Research Funding

Other

Background: Up to 70% of cancer survivors report clinically significant fear of cancer recurrence (FCR). This parallel RCT evaluated the impact of a psychological intervention, Conquer Fear (CF), on FCR in cancer survivors. Methods: Participants were disease-free stage I-III breast, colorectal or melanoma cancer survivors, 2 months to 5 years post-treatment, who scored above the clinical cut-off (≥13) on the FCR Inventory (FCRI) severity subscale. CF included 5 sessions incorporating attention training, detached mindfulness, challenging unhelpful metacognitions, values clarification and psycho-education. Participants were randomised to the intervention (n= 121) or a relaxation training (RT) control arm (n= 101) (target n= 260). The primary end-point was reduction in FCR (FCRI total) immediately after intervention completion. Follow-up assessments occurred immediately, 3- and 6-months post-treatment. Data analysis was by intention to treat. The differences in change in FCR from baseline between CF and RT and secondary outcomes were tested using independent t-tests. A difference of 14.5 points in FCR was considered clinically significant. Long-term changes in FCR and secondary outcomes were evaluated using linear regression models fitted with generalized estimating equations (GEE), adjusted for baseline FCR. Results: Reduction in FCR between baseline and immediately post-treatment was significantly more in CF participants compared to RT. (Difference in change (95% CI): -10.5 (-16.1, -4.9); p < 0.001). Greater FCR reductions were also observed amongst CF participants at 3 months (-7.6 (-13.9, -1.4), p = 0.02) and 6 months (-7.8 (-14.2, -1.4), p = 0.02) compared with RT. The pattern of change in outcomes over time was consistent between treatment groups as no significant linear trends in treatment effects over time were observed. Conclusions: Conquer Fear is a theoretically-grounded intervention to reduce FCR and its associated psychological morbidity which leads to significantly greater reductions in FCR in the first 6 months following treatment than relaxation training. Clinical trial information: ACTRN12612000404820.

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Abstract Details

Meeting

2017 ASCO Annual Meeting

Session Type

Oral Abstract Session

Session Title

Patient and Survivor Care

Track

Patient and Survivor Care

Sub Track

Survivorship

Clinical Trial Registration Number

ACTRN12612000404820

Citation

J Clin Oncol 35, 2017 (suppl; abstr LBA10000)

DOI

10.1200/JCO.2017.35.15_suppl.LBA10000

Abstract #

LBA10000

Abstract Disclosures