BMC Cancer 2009, 9:189 http://www.biomedcentral.com/1471-2407/9/189 participants; where $50,000 per QALY is taken as the benchmark for cost-effectiveness in Australia. Intervention The 'self help' self management materials will consist of an initial single 30-minute telephone support and education session with a nurse counsellor who will provide feedback to the participant about his/her levels of distress and instruction in evidence based strategies to improve adjust- ment. A self management manual will be developed pur- posefully for this study that will include self help in mood/ stress management skills; problem solving approaches to cancer-related concerns; patient education about a healthy lifestyle to promote wellness and optimise quality of life; strategies for mobilising personal and community support networks to reduce isolation and seek sustainable social support. For the individualised cognitive behavioural inter- vention (therapist delivered), five weekly one-hour sessions of tele-based counselling from a clinical psychologist will be delivered that include psychoeducation, skills in stress reduction, problem-solving, cognitive challenging and enhancing relationship support. Cognitive behavioural approaches are well established with regards to their clini- cal efficacy for anxiety and depression in cancer and indi- vidualised approaches are more effective than groups [29]. The individualised counselling sessions will follow princi- ples of cognitive-behavioural therapy and will utilise an adult learning approach in which participants self-select goals to focus on during the intervention. Content will include assigned behavioural homework that will be sup- ported by work and tip sheets. Components that target challenges associated with cancer treatments (e.g., pain, sleep disturbance, fatigue) will be additionally selected if relevant. Minutes of counselling time will be recorded for inclusion in analyses for both arms. Participants Study inclusion criteria will be that the patient/carer par- ticipants must: (1) be a cancer patient or carer ≥ 18 years of age who has called the Cancer Helpline for information or support (2) have a score of 4 or more on the Brief Dis- tress Thermometer at the time of the Helpline contact (3) be able to read and speak English (4) have no previous history of head injury, dementia or psychiatric illness. Callers who meet the selection criteria will be offered entry into the study by the Helpline operator at the time of the call; and once verbal permission to be contacted is obtained will be posted written consent and information forms. To minimise the period of time between calling the Helpline and randomisation into a support arm of the study, verbal consent to take part in the study will be obtained by project staff and audio taped prior to written consent. Baseline assessment will be conducted via tele- phone interview to prevent potential delays in receiving support. Participants will then be randomly allocated to receive either self management or the five session cogni- tive behavioural intervention. In all, 140 patients and 140 carers per condition will be recruited (allowing for a total of 280 people per treatment arm; 560 participants in total). On the basis of simulation work conducted by Rau- denbush and Xiao-Feng [33], the present study, with 4 measurement periods and a total N of 560 will have power of at least .90 to detect a moderate longitudinal effect size. This sample size will allow for identification and investigation of subgroups of patients and carers (high vs. low/borderline distress) on the basis of their response to psychological intervention. Study Integrity Ethical approval has been obtained from the Griffith Uni- versity Human research ethics Committee. The study design will be guided by the CONSORT statement [34]. Randomisation to study condition will occur following the completion of baseline assessment. Assessments will be by self-report pen and paper measures and project staff tracking assessments will be blinded to condition. Ran- domisation will be stratified by patient/carer and state (QLD vs NSW) and will occur in blocks of 10, with each condition randomly generated 5 times within each block to ensure an unpredictable allocation sequence with equal numbers of participants in each group at the completion of each block. This sequence will be undertaken by the project manager and concealed from investigators. Ther- apy will be manualised and all intervention calls audio- taped and reviewed to monitor treatment adherence. All analyses will be conducted on the basis of intention to treat. Measures A computer assisted telephone interview will be under- taken for the baseline assessment; subsequent assess- ments will be administered by mail at 3, 6 and to 12 months after recruitment. A short telephone interview at follow-up time points will also re-assess participants' use of support services. Primary outcomes are anxiety and depression, cancer specific distress and unmet psycholog- ical supportive care needs. Secondary outcomes are posi- tive adjustment and overall quality of life. Background variables will include socio-demographic and disease variables (e.g. cancer site and stage, medical treat- ments received, use of alternative therapies) and previous (past month) and current use of support services. Distress Screening The single item Brief Distress Thermometer (BDT) will be used to screen for global psychological distress [13]. This scale has good sensitivity and specificity when used with a cut off point of ≥ 4 [14]. 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