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1.  Improving sexual health in men with prostate cancer: randomised controlled trial of exercise and psychosexual therapies 
BMC Cancer  2014;14:199.
Background
Despite being a critical survivorship care issue, there is a clear gap in current knowledge of the optimal treatment of sexual dysfunction in men with prostate cancer. There is sound theoretical rationale and emerging evidence that exercise may be an innovative therapy to counteract sexual dysfunction in men with prostate cancer. Furthermore, despite the multidimensional aetiology of sexual dysfunction, there is a paucity of research investigating the efficacy of integrated treatment models. Therefore, the purpose of this study is to: 1) examine the efficacy of exercise as a therapy to aid in the management of sexual dysfunction in men with prostate cancer; 2) determine if combining exercise and brief psychosexual intervention results in more pronounced improvements in sexual health; and 3) assess if any benefit of exercise and psychosexual intervention on sexual dysfunction is sustained long term.
Methods/Design
A three-arm, multi-site randomised controlled trial involving 240 prostate cancer survivors will be implemented. Participants will be randomised to: 1) ‘Exercise’ intervention; 2) ‘Exercise + Psychosexual’ intervention; or 3) ‘Usual Care’. The Exercise group will receive a 6-month, group based, supervised resistance and aerobic exercise intervention. The Exercise + Psychosexual group will receive the same exercise intervention plus a brief psychosexual self-management intervention that addresses psychological and sexual well-being. The Usual Care group will maintain standard care for 6 months. Measurements for primary and secondary endpoints will take place at baseline, 6 months (post-intervention) and 1 year follow-up. The primary endpoint is sexual health and secondary endpoints include key factors associated with sexual health in men with prostate cancer.
Discussion
Sexual dysfunction is one of the most prevalent and distressing consequences of prostate cancer. Despite this, very little is known about the management of sexual dysfunction and current health care services do not adequately meet sexual health needs of survivors. This project will examine the potential role of exercise in the management of sexual dysfunction and evaluate a potential best-practice management approach by integrating pharmacological, physiological and psychological treatment modalities to address the complex and multifaceted aetiology of sexual dysfunction following cancer.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12613001179729.
doi:10.1186/1471-2407-14-199
PMCID: PMC3995188  PMID: 24641777
Prostate cancer; Sexual health; Erectile dysfunction; Exercise; Resistance training; Aerobic exercise; Psychosexual support; Self-management
2.  A randomised controlled trial of a mindfulness intervention for men with advanced prostate cancer 
BMC Cancer  2013;13:89.
Background
Prostate cancer is the most common male cancer in developed countries, and in Australia approximately one-fifth of men with prostate cancer have advanced disease. By comparison to men with localised prostate cancer, men with advanced disease report higher levels of psychological distress; poorer quality of life; and have an increased risk of suicide. To date no psychological intervention research specifically targeting men with advanced prostate cancer has been reported. In this paper we present the protocol of a current randomised controlled trial to assess the effectiveness of a professionally-led mindfulness-based cognitive therapy (MBCT) group intervention to improve psychological well-being in men with advanced prostate cancer.
Methods/design
Ninety-five men per condition (190 men in total) will be recruited through clinicians in the Australian and New Zealand Urogenital and Prostate Cancer Trials Group and in major treatment centres in Queensland, New South Wales, Victoria and Western Australia. Patients are randomised to: (1) tele-based MBCT intervention or (2) patient education. A series of previously validated and reliable self-report measures will be administered to men at four time points: baseline/recruitment, and at 3, 6, and 9 months after recruitment and intervention commencement. Engagement with the principles of mindfulness and adherence to practice will be included as potential mediators of intervention effect. Primary outcomes are anxiety, depression and cancer-specific distress. Secondary outcomes are health-related quality of life (QoL) and benefit finding. Disease variables (e.g. cancer grade, stage) will be assessed through medical records.
Discussion
This study will address a critical but as yet unanswered research question: to identify an effective way to reduce psychological distress; and improve the quality of life for men with advanced prostate cancer.
Trial registration
http://ACTRN12612000306819
doi:10.1186/1471-2407-13-89
PMCID: PMC3598536  PMID: 23442556
Prostate cancer; Randomised controlled trial (RCT); Supportive care; Mental health; Psychological distress; Quality of life; Health outcomes
3.  Can exercise ameliorate treatment toxicity during the initial phase of testosterone deprivation in prostate cancer patients? Is this more effective than delayed rehabilitation? 
BMC Cancer  2012;12:432.
Background
There has been substantial increase in use of androgen deprivation therapy as adjuvant management of prostate cancer. However, this leads to a range of musculoskeletal toxicities including reduced bone mass and increased skeletal fractures compounded with rapid metabolic alterations, including increased body fat, reduced lean mass, insulin resistance and negative lipoprotein profile, increased incidence of cardiovascular and metabolic morbidity, greater distress and reduced quality of life. Numerous research studies have demonstrated certain exercise prescriptions to be effective at preventing or even reversing these treatment toxicities. However, all interventions to date have been of rehabilitative intent being implemented after a minimum of 3 months since initiation of androgen deprivation, by which time considerable physical and psychological health problems have manifested. The pressing question is whether it is more efficacious to commence exercise therapy at the same time as initiating androgen deprivation, so treatment induced adverse effects can be immediately attenuated or indeed prevented.
Methods/design
We are proposing a multi-site randomized controlled trial with partial crossover to examine the effects of timing of exercise implementation (immediate or delayed) on preserving long-term skeletal health, reversing short- and long-term metabolic and cardiovascular risk factors, and supporting mental health in men receiving androgen deprivation therapy. 124 men who are about to initiate androgen deprivation for prostate cancer will be randomized to immediate or delayed groups. Immediate will commence a 6-month exercise program within 7–10 days of their first dose. Delayed will receive usual care for 6 months and then commence the exercise program for 6 months (partial cross-over). Immediate will be free to adopt the lifestyle of their choosing following the initial 6-month intervention. Measurements for primary and secondary endpoints will take place at baseline, 6 months and 12 months.
Discussion
This project is unique as it explores a fundamental question of when exercise implementation will be of most benefit and addresses both physical and psychological consequences of androgen deprivation initiation. The final outcome may be adjunct treatment which will reduce if not prevent the toxicities of androgen deprivation, ultimately resulting in reduced morbidity and mortality for men with prostate cancer.
Trial registration
ACTRN12612000097842
doi:10.1186/1471-2407-12-432
PMCID: PMC3519595  PMID: 23013489
Prostate cancer; Androgen deprivation therapy; Exercise; Resistance training; Aerobic training; Side-effects
4.  A systematic review of the impact of stigma and nihilism on lung cancer outcomes 
BMC Cancer  2012;12:184.
Background
This study systematically reviewed the evidence on the influence of stigma and nihilism on lung cancer patterns of care; patients’ psychosocial and quality of life (QOL) outcomes; and how this may link to public health programs.
Methods
Medline, EMBASE, ProQuest, CINAHL, PsycINFO databases were searched. Inclusion criteria were: included lung cancer patients and/or partners or caregivers and/or health professionals (either at least 80% of participants had lung cancer or were partners or caregivers of lung cancer patients, or there was a lung cancer specific sub-group focus or analysis), assessed stigma or nihilism with respect to lung cancer and published in English between 1st January 1999 and 31st January 2011. Trial quality and levels of evidence were assessed.
Results
Eighteen articles describing 15 studies met inclusion criteria. The seven qualitative studies were high quality with regard to data collection, analysis and reporting; however most lacked a clear theoretical framework; did not address interviewer bias; or provide a rationale for sample size. The eight quantitative studies were generally of low quality with highly selected samples, non-comparable groups and low participation rates and employed divergent theoretical and measurement approaches. Stigma about lung cancer was reported by patients and health professionals and was related to poorer QOL and higher psychological distress in patients. Clear empirical explorations of nihilism were not evident. There is qualitative evidence that from the patients’ perspectives public health programs contribute to stigma about lung cancer and this was supported by published commentary.
Conclusions
Health-related stigma presents as a part of the lung cancer experience however there are clear limitations in the research to date. Future longitudinal and multi-level research is needed and this should be more clearly linked to relevant theory.
doi:10.1186/1471-2407-12-184
PMCID: PMC3517321  PMID: 22607085
Lung neoplasms; Systematic review; Health-related stigma; Therapeutic nihilism
5.  Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial 
BMC Cancer  2011;11:517.
Background
The presence of bone metastases has excluded participation of prostate cancer patients in exercise intervention studies to date and is also a relative contraindication to supervised exercise in the community setting because of concerns of fragility fracture. However, this group of patients often have developed significant muscle atrophy and functional impairments from prior and continuing androgen deprivation that is exacerbated by subsequent and more intensive interventions such as chemotherapy. The aim of this study is to determine the efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases.
Methods/Design
Multi-site randomized controlled trial in Western Australia and New South Wales to examine the efficacy and safety of a modular multi-modal physical exercise program in 90 prostate cancer survivors with bone metastases. Participants will be randomized to (1) modular multi-modal exercise intervention group or (2) usual medical care group. The modular multi-modal exercise group will receive a 3-month supervised exercise program based on bone lesion location/extent. Measurements for primary and secondary endpoints will take place at baseline, 3 months (end of the intervention) and 6 months follow-up.
Discussion
Delaying or preventing skeletal complication and improving physical function for men with bone metastases would provide clinically meaningful benefits to patients. However, exercise programs must be designed and executed with careful consideration of the skeletal complications associated with bone metastatic disease and cumulative toxicities from androgen deprivation such as osteoporosis and increased risk of fractures. The results from this study will form the basis for the development of a specific exercise prescription in this patient group in order to alleviate disease burden, counteract the adverse treatment related side-effects and enhance quality of life.
Trial Registration
ACTRN: ACTRN12611001158954
doi:10.1186/1471-2407-11-517
PMCID: PMC3267706  PMID: 22166044
6.  A multilevel investigation of inequalities in clinical and psychosocial outcomes for women after breast cancer 
BMC Cancer  2011;11:415.
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.
doi:10.1186/1471-2407-11-415
PMCID: PMC3195770  PMID: 21951320
7.  Living with prostate cancer: randomised controlled trial of a multimodal supportive care intervention for men with prostate cancer 
BMC Cancer  2011;11:317.
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
doi:10.1186/1471-2407-11-317
PMCID: PMC3161036  PMID: 21791109
8.  Diagnostic and treatment pathways for men with prostate cancer in Queensland: investigating spatial and demographic inequalities 
BMC Cancer  2010;10:452.
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)
doi:10.1186/1471-2407-10-452
PMCID: PMC2936907  PMID: 20731875
9.  Feasibility of brief psychological distress screening by a community-based telephone helpline for cancer patients and carers 
BMC Cancer  2010;10:14.
Background
Up to one-third of people affected by cancer experience ongoing psychological distress and would benefit from screening followed by an appropriate level of psychological intervention. This rarely occurs in routine clinical practice due to barriers such as lack of time and experience. This study investigated the feasibility of community-based telephone helpline operators screening callers affected by cancer for their level of distress using a brief screening tool (Distress Thermometer), and triaging to the appropriate level of care using a tiered model.
Methods
Consecutive cancer patients and carers who contacted the helpline from September-December 2006 (n = 341) were invited to participate. Routine screening and triage was conducted by helpline operators at this time. Additional socio-demographic and psychosocial adjustment data were collected by telephone interview by research staff following the initial call.
Results
The Distress Thermometer had good overall accuracy in detecting general psychosocial morbidity (Hospital Anxiety and Depression Scale cut-off score ≥ 15) for cancer patients (AUC = 0.73) and carers (AUC = 0.70). We found 73% of participants met the Distress Thermometer cut-off for distress caseness according to the Hospital Anxiety and Depression Scale (a score ≥ 4), and optimal sensitivity (83%, 77%) and specificity (51%, 48%) were obtained with cut-offs of ≥ 4 and ≥ 6 in the patient and carer groups respectively. Distress was significantly associated with the Hospital Anxiety and Depression Scale scores (total, as well as anxiety and depression subscales) and level of care in cancer patients, as well as with the Hospital Anxiety and Depression Scale anxiety subscale for carers. There was a trend for more highly distressed callers to be triaged to more intensive care, with patients with distress scores ≥ 4 more likely to receive extended or specialist care.
Conclusions
Our data suggest that it was feasible for community-based cancer helpline operators to screen callers for distress using a brief screening tool, the Distress Thermometer, and to triage callers to an appropriate level of care using a tiered model. The Distress Thermometer is a rapid and non-invasive alternative to longer psychometric instruments, and may provide part of the solution in ensuring distressed patients and carers affected by cancer are identified and supported appropriately.
doi:10.1186/1471-2407-10-14
PMCID: PMC2826295  PMID: 20067645
10.  A randomised controlled trial of a tele-based lifestyle intervention for colorectal cancer survivors ('CanChange'): study protocol 
BMC Cancer  2009;9:286.
Background
Colorectal cancer survivors may suffer from a range of ongoing psychosocial and physical problems that negatively impact on quality of life. This paper presents the study protocol for a novel telephone-delivered intervention to improve lifestyle factors and health outcomes for colorectal cancer survivors.
Methods/Design
Approximately 350 recently diagnosed colorectal cancer survivors will be recruited through the Queensland Cancer Registry and randomised to the intervention or control condition. The intervention focuses on symptom management, lifestyle and psychosocial support to assist participants to make improvements in lifestyle factors (physical activity, healthy diet, weight management, and smoking cessation) and health outcomes. Participants will receive up to 11 telephone-delivered sessions over a 6 month period from a qualified health professional or 'health coach'. Data collection will occur at baseline (Time 1), post-intervention or six months follow-up (Time 2), and at 12 months follow-up for longer term effects (Time 3). Primary outcome measures will include physical activity, cancer-related fatigue and quality of life. A cost-effective analysis of the costs and outcomes for survivors in the intervention and control conditions will be conducted from the perspective of health care costs to the government.
Discussion
The study will provide valuable information about an innovative intervention to improve lifestyle factors and health outcomes for colorectal cancer survivors.
Trial Registration
ACTRN12608000399392
doi:10.1186/1471-2407-9-286
PMCID: PMC2746814  PMID: 19689801
11.  A phase III clinical trial of exercise modalities on treatment side-effects in men receiving therapy for prostate cancer 
BMC Cancer  2009;9:210.
Background
Androgen deprivation therapy (ADT) is accompanied by a number of adverse side effects including reduced bone mass and increased risk for fracture, reduced lean mass and muscle strength, mood disturbance and increased fat mass compromising physical functioning, independence, and quality of life. The purpose of this investigation is to examine the effects of long term exercise on reversing musculoskeletal-related side effects, and cardiovascular and diabetes risk factors in men receiving androgen deprivation for their prostate cancer. Specifically, we aim to investigate the effects of a 12-month exercise program designed to load the musculoskeletal system and reduce cardiovascular and diabetes disease progression on the following primary endpoints: 1) bone mineral density; 2) cardiorespiratory function and maximal oxygen capacity; 3) body composition (lean mass and fat mass); 4) blood pressure and cardiovascular function; 5) lipids and glycemic control; and 6) quality of life and psychological distress.
Methods/Design
Multi-site randomized controlled trial of 195 men (65 subjects per arm) undergoing treatment for prostate cancer involving ADT in the cities of Perth and Brisbane in Australia. Participants will be randomized to (1) resistance/impact loading exercise, (2) resistance/cardiovascular exercise groups and (3) usual care/delayed exercise. Participants will then undergo progressive training for 12 months. Measurements for primary and secondary endpoints will take place at baseline, 6 and 12 months (end of the intervention).
Discussion
The principal outcome of this project will be the determination of the strength of effect of exercise on the well established musculoskeletal, cardiovascular and insulin metabolism side effects of androgen deprivation in prostate cancer patients. As this project is much longer term than previous investigations in the area of exercise and cancer, we will gain knowledge as to the continuing effects of exercise in this patient population specifically targeting bone density, cardiovascular function, lean and fat mass, physical function and falls risk as primary study endpoints. In terms of advancement of prostate cancer care, we expect dissemination of the knowledge gained from this project to reduce fracture risk, improve physical and functional ability, quality of life and ultimately survival rate in this population.
Clinical Trial Registry
A Phase III clinical trial of exercise modalities on treatment side-effects in men receiving therapy for prostate cancer; ACTRN12609000200280
doi:10.1186/1471-2407-9-210
PMCID: PMC2713263  PMID: 19563641
12.  Beating the blues after Cancer: randomised controlled trial of a tele-based psychological intervention for high distress patients and carers 
BMC Cancer  2009;9:189.
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.
doi:10.1186/1471-2407-9-189
PMCID: PMC2709638  PMID: 19531265
13.  ProsCan for Couples: Randomised controlled trial of a couples-based sexuality intervention for men with localised prostate cancer who receive radical prostatectomy 
BMC Cancer  2008;8:226.
Background
Prostate cancer is the most common male cancer in the Western world. The most substantial long term morbidity from this cancer is sexual dysfunction with consequent adverse changes in couple and intimate relationships. Research to date has not identified an effective way to improve sexual and psychosocial adjustment for both men with prostate cancer and their partners. As well, the efficacy and cost effectiveness of peer counselling as opposed to professional models of service delivery has not yet been empirically tested. This paper presents the design of a three arm randomised controlled trial (peer vs. nurse counselling vs. usual care) that will evaluate the efficacy of two couples-based sexuality interventions (ProsCan for Couples: Peer support vs. nurse counselling) on men's and women's sexual and psychosocial adjustment after surgical treatment for localised prostate cancer; in addition to cost-effectiveness.
Methods/design
Seventy couples per condition (210 couples in total) will be recruited after diagnosis and before treatment through urology private practices and hospital outpatient clinics and randomised to (1) usual care; (2) eight sessions of peer-delivered telephone support with DVD education; and (3) eight sessions of oncology nurse-delivered telephone counselling with DVD education. Two intervention sessions will be delivered before surgery and six over the six months post-surgery. The intervention will utilise a cognitive behavioural approach along with couple relationship education focussed on relationship enhancement and helping the couple to conjointly manage the stresses of cancer diagnosis and treatment. Participants will be assessed at baseline (before surgery) and 3, 6 and 12 months post-surgery. Outcome measures include: sexual adjustment; unmet sexuality supportive care needs; attitudes to sexual help seeking; psychological adjustment; benefit finding and quality of life.
Discussion
The study will provide recommendations about the efficacy of peer support vs. nurse counselling to facilitate better sexual and couple adjustment after prostate cancer as well as recommendations on whether the interventions represent efficient health service delivery.
Trial Registration
ACTRN12608000358347
doi:10.1186/1471-2407-8-226
PMCID: PMC2529334  PMID: 18687149
14.  ProsCan for Men: Randomised controlled trial of a decision support intervention for men with localised prostate cancer 
BMC Cancer  2008;8:207.
Background
Prostate cancer is the most common male cancer in the Western world but is highly heterogeneous in disease progression and outcomes. Consequently, the most substantial morbidity may actually arise from the adverse psychosocial impact of distress in decision-making and long term quality of life effects such as impotence. This paper presents the design of a randomised controlled trial of a decision support/psychosocial intervention for men newly diagnosed with localised prostate cancer.
Methods/Design
350 men per condition (700 men in total) have been recruited after diagnosis and before treatment through urology private practices and hospital outpatient clinics and randomised to 1) a tele-based nurse delivered five session decision support/psychosocial intervention or 2) a usual care control group. Two intervention sessions are delivered before treatment that address decision support, stress management and preparation for treatment. Three further sessions are provided three weeks, seven weeks and five months after treatment that focus on adjustment to cancer, problem solving and coping with treatment side effects. Participants are assessed at baseline (before treatment) and 2, 6, 12, 24 and 36 months post-treatment. Outcome measures include: cancer threat appraisal; decision-related distress and bother from treatment side effects; involvement in decision making; satisfaction with health care; heath care utilisation; use of health care resources; and a return to previous activities.
Discussion
The study will provide recommendations about the efficacy of early decision support to facilitate adjustment after prostate cancer. As well the study will identify men diagnosed with localised prostate cancer at risk of poorer long term psychosocial adjustment.
Trial Registration
ACTRN012607000233426.
doi:10.1186/1471-2407-8-207
PMCID: PMC2515322  PMID: 18651985

Results 1-14 (14)