Supportive care needs and psychosocial outcomes of rural versus urban women with breast cancer.

OBJECTIVE: To identify whether supportive care needs vary according to remoteness and area-level socio-economic status and to identify the combinations of socio-demographic, area-level and health factors that are associated with poorer quality of life, psychological distress and severity of unmet supportive care needs. METHODS: Cross sectional data was collected from women with a breast cancer diagnosis (n = 2635) in Queensland, Australia, through a telephone survey including socio-demographic, health, psychosocial and supportive care needs measures. Hierarchical regression and cluster analyses were applied to assess the predictors of unmet need and psychosocial outcomes and to identify socio-demographic and health status profiles of women, comparing their level of unmet needs and psychosocial outcomes. RESULTS: Women living in outer regional areas reported the highest severity of unmet need in the patient care domain. Greater unmet need for health systems and information and patient care was also evident for those in moderately and most disadvantaged areas. Three clusters were identified reflecting (1) older women with poorer health and lower education (19%); (2) younger educated women with better health and private insurance (61%); and (3) physically active women with localised cancer who had completed treatment (20%). Poorer outcomes were evident in the first two of these clusters. CONCLUSIONS: This better understanding of the combinations of characteristics associated with poorer psychosocial outcomes and higher unmet need can be used to identify women with higher supportive care needs early and to target interventions.

Cost-Effectiveness Analysis of Supervised Exercise Training in Men with Prostate Cancer Previously Treated with Radiation Therapy and Androgen-Deprivation Therapy.

BACKGROUND: Exercise for prostate cancer (PCa) survivors has been shown to be effective in addressing metabolic function and associated co-morbidities, as well as sarcopenia and significant functional impairment resulting from long-term androgen deprivation. Evidence on the cost-effectiveness of exercise interventions for PCa, however, is lacking, thus the aim of this study was to determine the cost-effectiveness of a supervised exercise intervention for long-term PCa survivors who previously received radiation therapy and androgen-deprivation therapy. METHODS: Cost-effectiveness analysis from an Australian healthcare-payer perspective was conducted using patient-level data from a multicentre randomised controlled trial (RCT) of supervised exercise training (resistance and aerobic) compared to receiving printed exercise material and a recommendation to exercise in long-term PCa survivors (> 5 years post-diagnosis). Analysis was undertaken for the 6-month supervised exercise portion of the intervention, which involved 100 men aged between 62 and 85 years, 50 in each arm. The primary outcome was cost per quality-adjusted life-years (QALYs). RESULTS: A 6-month supervised exercise intervention for PCa survivors resulted in an incremental cost-effectiveness ratio of AU$64,235 (2018 AUD) at an incremental cost of AU$546 per person and a QALY gain of 0.0085. At a willingness-to-pay of AU$50,000, the probability that the intervention is cost-effective was 41%. Sensitivity analysis showed that maintenance of benefits via a 6-month home-based intervention, immediately following the supervised intervention, lowered the cost per QALY gained to AU$32,051. DISCUSSION: This is the first cost-effectiveness analysis of exercise for PCa survivors. The intervention was effective, but unlikely to be cost-effective at the generally accepted willingness-to-pay of AU$50,000 per QALY. It is likely that evidence to support cost savings from post-intervention outcomes would reveal greater benefits and contribute to a more comprehensive cost-effectiveness analysis. Future RCTs should incorporate longer follow-up durations and collection of data to support modelling to capture future health benefits. Measures of quality of life or utility more sensitive to the impact of physical activity would also improve future economic evaluations.

Community-based men's health promotion programs: eight lessons learnt and their caveats.

Long-standing commentaries about men's reticence for accessing clinical medical services, along with the more recent recognition of men's health inequities, has driven work in community-based men's health promotion. Indeed, the 2000s have seen rapid growth in community-based programs targeting men, and across this expanse of innovative work, experiential and empirical insights afford some important lessons learnt, and caveats to guide existing and future efforts. The current article offers eight lessons learnt regarding the design, content, recruitment, delivery, evaluation and scaling of community-based men's health promotion programs. Design lessons include the need to address social determinants of health and men's health inequities, build activity-based programming, garner men's permission and affirmation to shift masculine norms, and integrate content to advance men's health literacy. Also detailed are lessons learnt about men-friendly spaces, recruitment and retention strategies, the need to incrementally execute program evaluations, and the limits for program sustainability and scaling. Drawing from diverse community-based programs to illustrate the lessons learnt, caveats are also detailed to contextualize and caution some aspects of the lessons that are shared. The express aim of discussing lessons learnt and their caveats, reflected in the purpose of the current article, is to guide existing and future work in the ever growing field of community-based men's health promotion.

A systematic review of the unmet supportive care needs of men on active surveillance for prostate cancer.

OBJECTIVE: Understanding the unmet supportive care needs of men on active surveillance for prostate cancer may enable researchers and health professionals to better support men and prevent discontinuation when there is no evidence of disease progression. This review aimed to identify the specific unmet supportive care needs of men on active surveillance. METHODS: A systematic review following PRISMA guidelines was conducted. Databases (Pubmed, Embase, PsycINFO, and CINAHL) were searched to identify qualitative and/or quantitative studies that reported unmet needs specific to men on active surveillance. Quality appraisals were conducted before results were narratively synthesised. RESULTS: Of the 3613 unique records identified, only eight articles were eligible (five qualitative and three cross-sectional studies). Unmet Informational, Emotional/Psychological, Social, and "Other" needs were identified. Only three studies had a primary aim of investigating unmet supportive care needs. Small active surveillance samples, use of nonvalidated measures, and minimal reporting of author reflexivity in qualitative studies were the main quality issues identified. CONCLUSIONS: The unmet needs of men on active surveillance is an underresearched area. Preliminary evidence suggests the information available and provided to men during active surveillance is perceived as inadequate and inconsistent. Men may also be experiencing unmet psychological/emotional, social, and other needs; however, further representative, high-quality research is required to understand the magnitude of this issue. Reporting results specific to treatment type and utilising relevant theories/models (such as the social ecological model [SEM]) is recommended to ensure factors that may facilitate unmet needs are appropriately considered and reported.

Directing research funds to the right research projects: a review of criteria used by research organisations in Australia in prioritising health research projects for funding.

OBJECTIVES: Healthcare budgets are limited, and therefore, research funds should be wisely allocated to ensure high-quality, useful and cost-effective research. We aimed to critically review the criteria considered by major Australian organisations in prioritising and selecting health research projects for funding. METHODS: We reviewed all grant schemes listed on the Australian Competitive Grants Register that were health-related, active in 2017 and with publicly available selection criteria on the funders' websites. Data extracted included scheme name, funding organisation, selection criteria and the relative weight assigned to each criterion. Selection criteria were grouped into five representative domains: relevance, appropriateness, significance, feasibility (including team quality) and cost-effectiveness (ie, value for money). RESULTS: Thirty-six schemes were included from 158 identified. One-half of the schemes were under the National Health and Medical Research Council. The most commonly used criteria were research team quality and capability (94%), research plan clarity (94%), scientific quality (92%) and research impact (92%). Criteria considered less commonly were existing knowledge (22%), fostering collaboration (22%), research environment (19%), value for money (14%), disease burden (8%) and ethical/moral considerations (3%). In terms of representative domains, relevance was considered in 72% of the schemes, appropriateness in 92%, significance in 94%, feasibility in 100% and cost-effectiveness in 17%. The relative weights for the selection criteria varied across schemes with 5%-30% for relevance, 20%-60% for each appropriateness and significance, 20%-75% for feasibility and 15%-33% for cost-effectiveness. CONCLUSIONS: In selecting research projects for funding, Australian research organisations focus largely on research appropriateness, significance and feasibility; however, value for money is most often overlooked. Research funding decisions should include an assessment of value for money in order to maximise return on research investment.

Health literacy and the health status of men with prostate cancer.

OBJECTIVE: To test the Health Literacy Questionnaire (HLQ) in a sample of men with prostate cancer and examine the components of health literacy that are most strongly associated with mental and physical health-related quality of life in men with prostate cancer. METHOD: Members (N = 565) of a state-wide prostate cancer support network in Queensland, Australia (Mage  = 71.14, SD = 8.68) completed the HLQ along with the Medical Outcomes Study, 36-item short-form health survey (SF-36). Confirmatory factor analysis was employed to assess the internal structure of the HLQ. The effects (bs) of each of the nine health literacy factors on mental and physical health status were graphed and compared using Fishers exact test for comparing parameter estimates. RESULTS: Fit indices including RMSEA (0.069, CI = 0.066-0.072), CFI (.853), and TLI (.839), alongside item loadings and internal consistency (Cronbach alphas >0.80) for the nine-factor model, supported the robustness of the HLQ for use in this prostate cancer sample. Health literacy factors reflecting social and health provider support, navigating health systems, finding and understanding health information, and active engagement with providers shared small to moderate associations with mental health status and little to no association with physical health status. CONCLUSION: Findings provide support for the use of the HLQ as a valid and reliable measure of health literacy in men with prostate cancer. Although further research is required to establish causality, interventions that aim to improve skills in connecting and effectively communicating with health care services and providers might lead to better mental health related quality of life for men with prostate cancer.

Cancer care in regional Australia from the health professional's perspective.

PURPOSE: This study aimed to identify the factors which health professionals believe influence clinical care and outcomes for people with cancer in regional areas of Australia. METHODS: Twelve semi-structured interviews were conducted with a variety of health professionals. Interview questions explored health professional's perspectives on barriers to cancer care for patients, factors which influence clinical care, and access to support in regional areas. Data were interpreted using an inductive thematic analysis approach. RESULTS: Two global themes were identified: rural culture and the health system. Within these global themes, health professionals discussed barriers to cancer care in regional areas, predominantly associated with travel, limited workforce, and poor communication within the health system. Participants also noted many positive aspects of cancer care in regional areas, including more personalised care for the patients and faster career progression for professionals. CONCLUSIONS: Despite several strategies to improve rural cancer care in recent times, including innovative models of care and increased infrastructure, health professionals still perceive many barriers to cancer care in regional Australia. These are predominantly associated with patient demographics, travel difficulties, and inadequate governance. However, there are also many notable benefits to receiving care in regional areas which have been absent from previous literature. These positive factors should be incorporated in efforts to enhance regional cancer care through the recruitment of health professionals to regional areas and development of regional community support networks.

A study protocol for a randomised controlled trial of an interactive web-based intervention: CancerCope.

INTRODUCTION: Approximately 35% of patients with cancer experience clinically significant distress, and unmet psychological supportive care needs are prevalent. This study describes the protocol for a randomised controlled trial (RCT) to assess the efficacy and cost-effectiveness of an internet-based psychological intervention for distressed patients with cancer. METHODS AND ANALYSIS: In phase I, the intervention was developed on an interactive web platform and pilot tested for acceptability using a qualitative methodology with 21 patients with cancer. Phase II is an RCT underway with patients with or at risk of elevated psychological distress comparing: (1) static patient education website with (2) individualised web-delivered cognitive behavioural intervention (CancerCope). Participants were recruited through the Queensland Cancer Registry and Cancer Council Helpline and met the following inclusion criteria: (1) recently diagnosed with cancer; (2) able to read and speak English; (3) no previous history of head injury, dementia or psychiatric illness; (4) no other concurrent cancer; (5) phone and internet access; (5) scored ≥4 on the Distress Thermometer. Participants are assessed at four time points: baseline/recruitment and 2, 6 and 12 months after recruitment and intervention commencement. Of the 163 participants recruited, 50% met caseness for distress. The area of highest unmet supportive care needs were psychological followed by physical and daily living needs. Primary outcomes are psychological and cancer-specific distress and unmet psychological supportive care needs. Secondary outcomes are positive adjustment, quality of life and cost-effectiveness. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Griffith University Human Research Ethics Committee (Approval: PSY/70/13/HREC) and the Metro South Human Research Ethics Committee (HREC/13/QPAH/601). All participants provide informed consent prior to taking part in the study. Once completed, this study will provide recommendations about the efficacy of web-based cognitive behavioural interventions to facilitate better psychosocial adjustment for people with cancer. TRIAL REGISTRATION NUMBER: ANZCTR (ACTRN12613001026718).

What does it cost Medicare to diagnose and treat men with localized prostate cancer in the first year?

OBJECTIVE: To estimate costs on the Medicare Benefits Schedule (MBS) and the Pharmaceutical Benefits Scheme (PBS) attributable to the diagnosis and treatment of prostate cancer. METHODS: We used data from a cohort study of 1064 men with localized prostate cancer recruited between 2005 and 2007 by 24 urologists across 10 sites in Queensland, Australia (ProsCan). We estimated the MBS and PBS costs attributable to prostate cancer from the date of initial appointment to 12 months after diagnosis in 2013 Australian dollars using a comparison group without prostate cancer. We used generalized linear modeling to identify key determinants of higher treatment-related costs. RESULTS: From the date of initial appointment to 12 months postdiagnosis, the average MBS costs attributable to prostate cancer were $9,357 (SD $191) per patient. These MBS costs were most sensitive to having private health insurance and the type of primary treatment received. The PBS costs were higher in the control group than in the ProsCan group ($5,641 vs $1,924). CONCLUSIONS: The costs of treating and managing prostate cancer are high and these result in a substantial financial burden for the Australian MBS. Costs attributable to prostate cancer appear to vary widely based on initial treatment and these are likely to increase with the introduction of more expensive services and pharmaceuticals. There is a pressing need for better prognostic tools to distinguish between indolent and aggressive prostate tumors to reduce potential over treatment and help ease the burden of prostate cancer.

Mindfulness-Based Cognitive Therapy in Advanced Prostate Cancer: A Randomized Controlled Trial.

Purpose Advanced prostate cancer (PC) is associated with substantial psychosocial morbidity. We sought to determine whether mindfulness-based cognitive therapy (MBCT) reduces distress in men with advanced PC. Methods Men with advanced PC (proven metastatic and/or castration-resistant biochemical progression) were randomly assigned to an 8-week, group-based MBCT intervention delivered by telephone (n = 94) or to minimally enhanced usual care (n = 95). Primary intervention outcomes were psychological distress, cancer-specific distress, and prostate-specific antigen anxiety. Mindfulness skills were assessed as potential mediators of effect. Participants were assessed at baseline and were followed up at 3, 6, and 9 months. Main statistical analyses were conducted on the basis of intention to treat. Results Fourteen MBCT groups were conducted in the intervention arm. Facilitator adherence ratings were high (> 93%). Using random-effects mixed-regression models, intention-to-treat analyses indicated no significant changes in intervention outcomes or in engagement with mindfulness for men in MBCT compared with those receiving minimally enhanced usual care. Per-protocol analyses also found no differences between arms in outcomes or engagement, with the exception of the mindfulness skill of observing, which increased over time for men in MBCT compared with usual care ( P = .032). Conclusion MBCT in this format was not more effective than minimally enhanced usual care in reducing distress in men with advanced PC. Future intervention research for these men should consider approaches that map more closely to masculinity.

Assessing the effectiveness of decision aids for decision making in prostate cancer testing: a systematic review.

BACKGROUND: Prostate cancer is a leading disease affecting men worldwide. Conflicting evidence within the literature provides little guidance to men contemplating whether or not to be screened for prostate cancer. This systematic review aimed to determine whether decision aids about early detection of prostate cancer improve patient knowledge and decision making about whether to undergo prostate-specific antigen testing. METHODS: Medline, EMBASE, CINAHL, PsychINFO, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects and Health Technology Assessment databases up until March 2014 were searched. All included randomised controlled trials were assessed for methodological quality. Clinical selection and assessment heterogeneity among studies prevented the pooling of data for meta-analyses. Descriptive analyses of all included studies and comparison were performed. RESULTS: A total of 13 randomised controlled trials met the inclusion criteria. Significant heterogeneity was present for the design and implementation of decision aids including comparative interventions and outcomes. Eight studies were of a low methodological quality, with the remaining five of medium quality. Improvements in patient knowledge following use of a decision aid were demonstrated by 11 of the 13 included studies. Seven of 10 studies demonstrated a reduction in decisional conflict/distress. Three of four studies demonstrated no difference between a decision aid and information only in reducing decisional uncertainty. Three of five studies demonstrated an increase in decisional satisfaction with use of a decision aid. CONCLUSIONS: Decision aids increase patient knowledge and confidence in decision making about prostate cancer testing. Further research into effective methods of implementation is needed. Copyright © 2015 John Wiley & Sons, Ltd.

A systematic review of episodic volunteering in public health and other contexts.

BACKGROUND: Episodic volunteers are a critical resource for public health non-profit activities but are poorly understood. A systematic review was conducted to describe the empirical evidence about episodic volunteering (EV) in the public health sector and more broadly. Study location, focus and temporal trends of EV research were also examined. METHODS: Twelve key bibliographic databases (1990-April week 2, 2014) were searched, including Google Scholar. Empirical studies published in English in peer-reviewed journals that identified participants as EVs who volunteered to support Not-for-Profit organisations in the health and social welfare sectors were included. EV definitions, characteristics, economic costs, antecedents and outcomes and theoretical approaches were examined. RESULTS: 41 articles met initial review criteria and 20 were specific to the health or social welfare sectors. EV definitions were based on one or more of three dimensions of duration, frequency, and task. EVs were predominantly female, middle aged, Caucasian (North American) and college/university educated. Fundraising was the most common EV activity and 72% had volunteered at least once. No studies examined the economic costs of EV. There was little consistency in EV antecedents and outcomes, except motives which primarily related to helping others, forming social connections, and self-psychological or physical enhancement. Most studies were atheoretical. Three authors proposed new theoretical frameworks. CONCLUSIONS: Research is required to underpin the development of an agreed consensus definition of EV. Moreover, an EV evidence-base including salient theories and measures is needed to develop EV engagement and retention strategies for the health and social welfare sectors.

Health-related quality of life and life satisfaction in colorectal cancer survivors: trajectories of adjustment.

BACKGROUND: This longitudinal study describes the five year trajectories of health-related quality of life (HR-QOL) and life satisfaction in long term colorectal cancer survivors. PATIENTS AND METHODS: A population-based sample of 1966 colorectal cancer survivors were surveyed at six time points from five months to five years post-diagnosis. Predictor variables were: socio-demographic variables, optimism; cancer threat appraisal; perceived social support. Quality of life was assessed with the Functional Assessment of Cancer Therapy-Colorectal (HR-QOL); and the Satisfaction with Life Scale. Growth mixture models were applied to identify trajectory classes and their predictors. RESULTS: Distinct adjustment trajectories were identified for HR-QOL and life satisfaction. Lower optimism, poorer social support, a more negative cognitive appraisal, and younger age were associated with poorer life satisfaction, while survivors with less than 8 years of education had higher life satisfaction. This pattern was similar for overall HR-QOL except that educational level was not a significant predictor and later stage disease and female gender emerged as related to poorer outcomes. One in five survivors reported poorer constant HR-QOL (19.2%) and a small group had poor life satisfaction (7.2%); 26.2% reported constant high HR-QOL and 48.8% had high constant life satisfaction. Socioeconomic disadvantage and remoteness of residence uniquely predicted poorer outcomes in the colorectal cancer specific HR-QOL sub domain. CONCLUSION: Although HR-QOL and subjective cognitive QOL share similar antecedents their trajectory patterns suggested they are distinct adjustment outcomes; with life satisfaction emerging as temporally stable phenomenon. Unique patterns of risk support suggest the need to account for heterogeneity in adjustment in longitudinal QOL studies with cancer survivors.

A multilevel investigation of inequalities in clinical and psychosocial outcomes for women after breast cancer.

BACKGROUND: In Australia, breast cancer is the most common cancer affecting Australian women. Inequalities in clinical and psychosocial outcomes have existed for some time, affecting particularly women from rural areas and from areas of disadvantage. We have a limited understanding of how individual and area-level factors are related to each other, and their associations with survival and other clinical and psychosocial outcomes. METHODS/DESIGN: This study will examine associations between breast cancer recurrence, survival and psychosocial outcomes (e.g. distress, unmet supportive care needs, quality of life). The study will use an innovative multilevel approach using area-level factors simultaneously with detailed individual-level factors to assess the relative importance of remoteness, socioeconomic and demographic factors, diagnostic and treatment pathways and processes, and supportive care utilization to clinical and psychosocial outcomes. The study will use telephone and self-administered questionnaires to collect individual-level data from approximately 3, 300 women ascertained from the Queensland Cancer Registry diagnosed with invasive breast cancer residing in 478 Statistical Local Areas Queensland in 2011 and 2012. Area-level data will be sourced from the Australian Bureau of Statistics census data. Geo-coding and spatial technology will be used to calculate road travel distances from patients' residence to diagnostic and treatment centres. Data analysis will include a combination of standard empirical procedures and multilevel modelling. DISCUSSION: The study will address the critical question of: what are the individual- or area-level factors associated with inequalities in outcomes from breast cancer? The findings will provide health care providers and policy makers with targeted information to improve the management of women with breast cancer, and inform the development of strategies to improve psychosocial care for women with breast cancer.

Living with prostate cancer: randomised controlled trial of a multimodal supportive care intervention for men with prostate cancer.

BACKGROUND: Prostate cancer is the most common male cancer in developed countries and diagnosis and treatment carries with it substantial morbidity and related unmet supportive care needs. These difficulties may be amplified by physical inactivity and obesity. We propose to apply a multimodal intervention approach that targets both unmet supportive care needs and physical activity. METHODS/DESIGN: A two arm randomised controlled trial will compare usual care to a multimodal supportive care intervention "Living with Prostate Cancer" that will combine self-management with tele-based group peer support. A series of previously validated and reliable self-report measures will be administered to men at four time points: baseline/recruitment (when men are approximately 3-6 months post-diagnosis) and at 3, 6, and 12 months after recruitment and intervention commencement. Social constraints, social support, self-efficacy, group cohesion and therapeutic alliance will be included as potential moderators/mediators of intervention effect. Primary outcomes are unmet supportive care needs and physical activity levels. Secondary outcomes are domain-specific and health-related quality of life (QoL); psychological distress; benefit finding; body mass index and waist circumference. Disease variables (e.g. cancer grade, stage) will be assessed through medical and cancer registry records. An economic evaluation will be conducted alongside the randomised trial. DISCUSSION: This study will address a critical but as yet unanswered research question: to identify a population-based way to reduce unmet supportive care needs; promote regular physical activity; and improve disease-specific and health-related QoL for prostate cancer survivors. The study will also determine the cost-effectiveness of the intervention. TRIAL REGISTRATION: ACTRN12611000392965.

Diagnostic and treatment pathways for men with prostate cancer in Queensland: investigating spatial and demographic inequalities.

BACKGROUND: Patterns of diagnosis and management for men diagnosed with prostate cancer in Queensland, Australia, have not yet been systematically documented and so assumptions of equity are untested. This longitudinal study investigates the association between prostate cancer diagnostic and treatment outcomes and key area-level characteristics and individual-level demographic, clinical and psychosocial factors. METHODS/DESIGN: A total of 1064 men diagnosed with prostate cancer between February 2005 and July 2007 were recruited through hospital-based urology outpatient clinics and private practices in the centres of Brisbane, Townsville and Mackay (82% of those referred). Additional clinical and diagnostic information for all 6609 men diagnosed with prostate cancer in Queensland during the study period was obtained via the population-based Queensland Cancer Registry.Respondent data are collected using telephone and self-administered questionnaires at pre-treatment and at 2 months, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months post-treatment. Assessments include demographics, medical history, patterns of care, disease and treatment characteristics together with outcomes associated with prostate cancer, as well as information about quality of life and psychological adjustment. Complementary detailed treatment information is abstracted from participants' medical records held in hospitals and private treatment facilities and collated with health service utilisation data obtained from Medicare Australia. Information about the characteristics of geographical areas is being obtained from data custodians such as the Australian Bureau of Statistics. Geo-coding and spatial technology will be used to calculate road travel distances from patients' residences to treatment centres. Analyses will be conducted using standard statistical methods along with multilevel regression models including individual and area-level components. CONCLUSIONS: Information about the diagnostic and treatment patterns of men diagnosed with prostate cancer is crucial for rational planning and development of health delivery and supportive care services to ensure equitable access to health services, regardless of geographical location and individual characteristics.This study is a secondary outcome of the randomised controlled trial registered with the Australian New Zealand Clinical Trials Registry (ACTRN12607000233426).

Beating the blues after cancer: randomised controlled trial of a tele-based psychological intervention for high distress patients and carers.

BACKGROUND: The diagnosis and treatment of cancer is a major life stress such that approximately 35% of patients experience persistent clinically significant distress and carers often experience even higher distress than patients. This paper presents the design of a two arm randomised controlled trial with patients and carers who have elevated psychological distress comparing minimal contact self management vs. an individualised tele-based cognitive behavioural intervention. METHODS/DESIGN: 140 patients and 140 carers per condition (560 participants in total) will been recruited after being identified as high distress through caller screening at two community-based cancer helplines and randomised to 1) a single 30-minute telephone support and education session with a nurse counsellor with self management materials 2) a tele-based psychologist delivered five session individualised cognitive behavioural intervention. Session components will include stress reduction, problem-solving, cognitive challenging and enhancing relationship support and will be delivered weekly. Participants will be assessed at baseline and 3, 6 and 12 months after recruitment. Outcome measures include: anxiety and depression, cancer specific distress, unmet psychological supportive care needs, positive adjustment, overall Quality of life. DISCUSSION: The study will provide recommendations about the efficacy and potential economic value of minimal contact self management vs. tele-based psychologist delivered cognitive behavioural intervention to facilitate better psychosocial adjustment and mental health for people with cancer and their carers. TRIAL REGISTRATION: ACTRN12609000301268.