Research projects

Evaluation of a psychological and educational intervention for fear of cancer recurrence: A cluster randomised controlled trial

Principal researchers

Professor Phyllis Butow1
Belinda Thewes1
Jane Turner 2
Jemma Gilchrist3
Afaf Girgis 4
Louise Sharpe,5
Melanie Bell1
Jane Beith 6
Cathy Mihalopoulos 7
Francis Boyle 8
Stephen Clarke 9
Madeleine King 10, 11
Alison Boyes 4
Geraldine Hill (consumer)
Dennis Armstrong, (consumer representative)10

Institution

1 University of Sydney
2 University of Queensland
3 Westmead Cancer Centre
4 Newcastle University
5 University of NSW
6 Royal Prince Alfred Hospital
7 Deakin University
8 Mater Hospital, NSW
9 Royal North Shore Hospital
10 PoCoG Joint consumer Advisory Group
11 Cancer Australia

Funding

$165,567 (total funding $496,702)

Co-funded with

Cancer Australia

Award type

Priority-driven Collaborative Cancer Research Scheme (PdCCRS)

Project completion year

2014

Project brief

In 2004 there were approximately 655,000 cancer survivors in Australia who had been diagnosed with cancer during the previous 23 years. Research has shown that fear of cancer recurrence (FCR) is an almost ubiquitous experience for cancer survivors. Help for FCR is the most prevalent unmet need reported by cancer survivors in multiple studies, with up to 30 per cent of Australian cancer patients reporting a moderate to high unmet need for help with FCR.

For some survivors, FCR can be chronic and disabling. FCR is associated with increased anxiety, depression, stress-response symptoms and poorer quality of life. There is evidence that it is associated with both excessive use of and/or avoidance of self-examination and medical tests for secondary cancer. As a result, there is likely to be an excessive use of medical tests and surveillance and possible increased rates of secondary cancer due to avoidance of recommended tests. However, such economic costs have not yet been systematically evaluated. Despite a growing awareness of the prevalence and impact of FCR, there have been few interventions to help those affected by severe FCR to better manage their fears and engage in more appropriate forms of medical surveillance. To date, only one paper has described a psychological intervention specifically designed to reduce FCR amongst cancer survivors, and no data on its efficacy has been published. The research group has developed and piloted a new, theoretically grounded intervention for FCR which they plan to evaluate in this clustered randomised controlled trial (RCT).

Aim

To evaluate the efficacy and cost efficacy of an intervention based on Meta-cognitive Therapy, Acceptance and Commitment Therapy and the Common Sense Model, in reducing the impact of FCR on disease-free cancer survivors with elevated FCR, compared to a relaxation timing control intervention.

Method

Participants (N=324) will have had a diagnosis of early-stage breast or colorectal cancer, be aged 18 years or over and will have completed their hospital-based treatment at least two months prior to study entry. They will be disease-free, and report a score in the clinical range (13 or more) on the Severity Subscale of the Fear of Cancer Recurrence Inventory (FCRI). Recruitment will be via participating oncology clinics and community-based cancer services.

The intervention and control treatments will be delivered by 18 psychologists or psychiatrists working in hospital oncology clinics or cancer-specific community services across Australia.

Therapists will be randomised to deliver either the five-session FCR intervention, or a five-session generic relaxation training program. Fidelity to treatment protocols will be ensured by a number of methods including:

  • regular review of session checklists
  • therapist participation in monthly group supervision
  • recording of all therapy sessions with review of a random selection of recordings by members of the research team with feedback given where non-fidelity is identified.

Participants will complete baseline measures prior to the initial therapy session and follow-up measures immediately after completion of the intervention, then three months and six months later.

The proposed intervention has direct implications for the development of support services for cancer survivors both in Australia and internationally. Effective intervention for FCR will reduce psychological morbidity and improve quality of life (QoL) amongst cancer survivors with elevated FCR, and may reduce overall healthcare costs due to more appropriate use of follow-up care and other health services in this very large population.