BMC Cancer 2009, 9:189 http://www.biomedcentral.com/1471-2407/9/189 eight months [29]. While these results are impressive, this approach will require specialist psychological staff, infra- structure to support delivery, and compliance by patients with routinised therapy sessions. In comparison, minimal contact approaches to psychological care with the use of self management materials for people with sub-threshold depression have been found to reduce the later incidence of major depression in patients in primary care [30]. Effi- cacious self management has been defined as where indi- viduals are able to monitor their own condition and undertake the necessary cognitive, behavioural and emo- tional responses to effect a satisfactory quality of life [31]. Self management interventions have been shown to have consistent positive effects on mood across a range of chronic illnesses [31] and so have great potential as a cost effective method of providing psychological support to people affected by cancer. Proposed advantages of self management approaches are equity, accessibility and choice [32]. However, it is not yet clear for which dis- tressed patients a minimal contact approach would be efficacious, and for whom more in depth individualised approaches are necessary. For example, it may be that patients and carers with borderline distress will return to pre-morbid functioning with minimal contact approaches while clinically distressed people will require more in depth care to achieve similar benefits. This is a research question that is of critical importance in order to guide the cost-effective delivery of psychosocial oncology care serv- ices for the population. For practical capacity for immediate translation into the community, psychosocial distress screening and interven- tion should be nested within an available service infra- structure. The Cancer Helpline provides a unique service infrastructure with demonstrated feasibility for the deliv- ery of well-evaluated tools to diagnose psychosocial dis- tress and depression/anxiety in people with cancer in our community, and their family members and carers; and potential for the delivery of psychosocial interventions. The Cancer Helpline has unique broad access intervention capacity. The service has national coverage with uniform service standards; is promoted in national patient and cli- nician educational materials as a contact for evidence- based cancer support and information; national media coverage about cancer consistently uses the Cancer Hel- pline as a referral point for the public; the use of a tele- based delivery mode with a toll free contact number addresses geographical, disability, illness and cost barriers to access; the service is community based and accessible at any point in the illness continuum. Each year nationally over 30,000 patients and carers contact the Helpline. However, research is needed to extend the Helpline to include in depth psychosocial intervention; and to assess the relative efficacy of minimal contact approaches with individualised care. The present study will evaluate the relative efficacy and cost-effectiveness of these two approaches to psychosocial intervention for people dis- tressed by cancer that are suitable for immediate popula- tion-based translation. Methods/design Study aims and hypotheses The overall aim of the proposed study is to compare the efficacy and cost effectiveness of minimal contact self management materials vs. a tele-based psychologist deliv- ered cognitive behavioural intervention in improving psy- chological outcomes for high distress cancer patients and carers over a 12 month period. Callers who contact The Cancer Council Cancer Helpline in Queensland and New South Wales over a five month time period will be screened for psychosocial distress and those callers with elevated distress will be randomised to one of the two study arms. The two study arms will comprise: (1) minimal con- tact self management vs. (2) five sessions of an individu- alised tele-based cognitive behavioural intervention delivered by a clinical psychologist. Study hypotheses: It is hypothesised that 3, 6, and 12 months after recruitment: 1. Participants in both study arms will experience signifi- cant improvements in mental health compared to base- line levels including: reduced anxiety and depression; cancer specific distress; unmet psychological supportive care needs; and increased positive adjustment and quality of life. 2. Participants with borderline anxiety/depression who receive the minimal contact self management condition will experience significantly less anxiety and depression; less cancer specific distress, lower unmet psychological supportive care needs, higher positive adjustment and improved quality of life by comparison to participants with high anxiety/depression who receive the minimal con- tact self management condition. 3. Participants with high anxiety/depression who receive the individualised tele-based cognitive behavioural interven- tion condition will experience significantly less anxiety and depression; less cancer specific distress, lower unmet psychological supportive care needs, higher positive adjustment and improved quality of life by comparison to participants with high anxiety/depression who receive the minimal contact self management condition. 4. That from a health sector perspective, the individual- ised tele-based cognitive behavioural intervention is more 'cost-effective' compared to the minimal contact self man- agement comparator for high anxiety/depression partici- pants, and minimal contact self management is more cost- effective than the individualised tele-based cognitive behavioural intervention for borderline anxiety/depression Page 3 of 7 (page number not for citation purposes)