BMC Cancer 2009, 9:189 http://www.biomedcentral.com/1471-2407/9/189 Psychological Distress The Brief Symptom Inventory – 18 (BSI-18) will assess psychological distress through three subscales of anxiety, depression, and somatisation [35]. that identifies cases with similar distress and adjustment trajectories across time [43]. Jo's [44] results suggest that the proposed sample size will be sufficient to examine subgroups of responders. Cancer Specific Distress The Impact of Events Scale (IES: [36,37]) will be used to assess cancer specific distress. The IES has two subscales that measure the extent to which participants are experi- encing intrusive thoughts about cancer and avoiding thinking about cancer [38]. Unmet Psychological Supportive Care Needs The Supportive Care Needs Survey Short Form 34 (SCNS- SF34) will assess cancer patients' need for help over the last month across 5 domains: psychological, health sys- tems and information, patient care and support, physical and daily living, and sexuality needs [39,40]. The Support- ive Care Needs Survey for Partners and Caregivers (SCNS- P&C45) will assess carers' need for help over the last month. Positive Adjustment Positive adjustment will be measured with a 21-item Post- traumatic Growth Inventory (PTGI) assessing perceived positive life changes occurring after a diagnosis of cancer [41]. Domains assessed include strengthened relation- ships with others, appreciation of life, personal strength, new priorities, spiritual/religious growth. Quality of Life Health related quality of life will be measured with the Assessment of Quality of Life – 2 (AQoL-2), which is a more recent version of the original 15-item AQol. The AQoL-2 is a 20-item scale assessing quality of life on six dimensions; including independent living, social, mental health, coping, pain, and sensory perception [42]. The AQoL will also be used to assess the cost-effectiveness of the intervention options. AQoL utility data analysis will be used to estimate Quality-adjusted life years (QALYs). Statistical Analyses The study is a multivariate, two condition randomized controlled trial with repeated measures across time. The analytic approach will be a multilevel model (MLM) in which measurement occasions (level 1) are nested within persons (level 2) and in which state/program differences are represented as a fixed effect at level 2 whose interac- tion with time represents differential adjustment and dis- tress trajectories for the two groups. A key advantage of this approach is flexibility in dealing with missing data owing either to random or non-random attrition. Further, subgroups of patients and carers who respond differen- tially to the program will be identified using growth mix- ture modelling that is a related longitudinal procedure Economic Analyses A trial-based economic evaluation will be conducted that integrates the efficacy and quality of life outcomes data with comparative cost data on the intervention options. The various distress indicators and the unmet needs data will be built in incremental cost-effectiveness analysis (CEA), while the quality of life data will be used in cost- utility analysis (CUA) using the Brazier algorithm. The feasibility of adding a modelled economic evaluation (to broaden the target population; lengthen the time horizon beyond that of the trial; and estimate cost offsets) will also be carefully assessed, having regard to trial results and the strength of evidence in the literature to underpin key modelling assumptions. Costs and outcomes will be assessed from a health sector perspective, but with a focus on 'government as 3rd party funder'. Cost impacts that fall on patients and their carers/ families will be reported to the extent they can be assessed from the activity data; but this collection will not be com- plete. Pathway analysis and patient flowcharts (incorpo- rating decision tree analysis) will be used to clearly identify and cost the activity components for each arm of the trial. Standard discounting will be applied to both costs and outcomes, together with detailed sensitivity test- ing (using @RISK probabilistic software). Discussion This study will address a critical research question: what is the efficacy and cost-effectiveness of population based strategies for promoting optimal psychosocial adjustment and mental health for people with cancer and their carers who are at risk? To date, intervention studies have typi- cally not been adequately powered to look differentially at effects for high versus borderline/low distress patients and carers; or included economic analyses for cost-benefit. This research will overcome these limitations. Most importantly however, the proposed study will also pro- vide a strategy for delivering in depth intervention to high distress individuals that can be immediately translatable into broad reach tele-health services both in Australia and internationally; and potentially replicated for other chronic illnesses. Abbreviations BDT: Brief Distress Thermometer; QALY: Quality-adjusted life years; HADS: Hospital Anxiety and Depression Scale; QLD: Queensland; NSW: New South Wales; BSI-18: Brief Symptom Inventory 18; IES: Impact of Events Scale; SCNS-SF34: Supportive Care Needs Survey Short Form 34; Page 5 of 7 (page number not for citation purposes)