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 healthrelated 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 populationbased 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.

An internet-based psychosocial Intervention for men treated for prostate cancer

This thesis developed and evaluated an internet-based program addressing many of the unmet psychological and social needs of men treated for localised prostate cancer. The program was found to be appealing to men and there were trends towards significant improvement across areas of sexuality and relationship function.

My road ahead study protocol: a randomised controlled trial of an online psychological intervention for men following treatment for localised prostate cancer

There is a need for psychosocial interventions for men with prostate cancer to promote adaptive coping with the challenges and distress associated with diagnosis, treatment and recovery. In addition, interventions are needed that help to overcome barriers to psychosocial treatment such as limited face-to-face psychosocial support services, a shortage of adequately trained professionals, geographical distance, perceived and personal stigma and a preference for consumer-centric and self-directed learning. My Road Ahead is an online cognitive behaviour therapy (CBT) intervention for prostate cancer. This protocol describes a randomised controlled trial (RCT) that will evaluate the efficacy of this online intervention alone, the intervention in combination with a moderated online forum, and the moderated online forum alone.

Development, feasibility and usability of an online psychological intervention for men with prostate cancer: my road ahead

Men with prostate cancer are not routinely offered psychosocial support despite strong evidence that being diagnosed with prostate cancer poses significant quality of life concerns and places the patient at elevated risk of developing a range of mental health disorders. The objective of this study was to develop an online psychological intervention for men with prostate cancer and to pilot test the feasibility and acceptability of the intervention. Development of the intervention involved a multidisciplinary collaboration, adapting face-to-face and group intervention strategies for an online format. The full online intervention and moderated forum were pilot tested with 64 participants who were recruited from urology practices in Melbourne, Victoria, Australia. After consenting to participate and creating a personal account in the online programme, participants completed baseline demographic questionnaires. Participants were provided access to the programme for 6-12. weeks. After completing the programme participants completed an online survey to assess intervention and forum utilisation and satisfaction, as well as suggest intervention refinements following their use of the intervention. Patient satisfaction was calculated using mean responses to the satisfaction questionnaire. The intervention was received positively with 47.82% of participants highly satisfied with the programme, and 78.26% said they would recommend it to a friend. Participants' qualitative feedback indicated good acceptability of the online intervention. A number of technical and participant engagement issues were identified and changes recommended as a result of the feasibility testing.

Characteristics of participants in Australia's Get Healthy telephone-based lifestyle information and coaching service : reaching disadvantaged communities and those most at need

To address increasing rates of overweight and obesity, a population-based telephone intervention was introduced in New South Wales, Australia. The Get Healthy Information and Coaching Service® (GHS) offered participants a 6-month coaching program or detailed self-help information. Determining the population reach of GHS is of public health importance to ensure that the program reaches disadvantaged groups. This paper describes the socio-demographic and risk profile of participants (n = 4828) in the first 18 months of operations, determines how representative they are of the population, assesses changes in participants’ socio-demographic profile and compares ‘information-only’ and ‘coaching’ participants. The results show that GHS users are representative of the adult population in relation to education, employment status, Aboriginal status, fruit and vegetable consumption and alcohol use. However, more female, middle-aged, English-speaking, rural and socially disadvantaged adults participated in GHS. Coaching Participants were more likely to be overweight and to be ex-smokers than the general population. There was substantial variability in GHS recruitment, when mass-reach television advertising was used, participants enrolled from a major city and from more disadvantaged communities. The GHS has broader population reach than many local interventions, but further efforts are needed to increase reach by Aboriginal communities, other minorities and men.

Timing of androgen-deprivation therapy in patients with prostate cancer with a rising PSA (TROG 03.06 and VCOG PR 01-03 [TOAD]): a randomised, multicentre, non-blinded, phase 3 trial

Background Androgen-deprivation therapy is offered to men with prostate cancer who have a rising prostate-specific antigen after curative therapy (PSA relapse) or who are considered not suitable for curative treatment; however, the optimal timing for its introduction is uncertain. We aimed to assess whether immediate androgen-deprivation therapy improves overall survival compared with delayed therapy. Methods In this randomised, multicentre, phase 3, non-blinded trial, we recruited men through 29 oncology centres in Australia, New Zealand, and Canada. Men with prostate cancer were eligible if they had a PSA relapse after previous attempted curative therapy (radiotherapy or surgery, with or without postoperative radiotherapy) or if they were not considered suitable for curative treatment (because of age, comorbidity, or locally advanced disease). We used a database-embedded, dynamically balanced, randomisation algorithm, coordinated by the Cancer Council Victoria, to randomly assign participants (1:1) to immediate androgen-deprivation therapy (immediate therapy arm) or to delayed androgen-deprivation therapy (delayed therapy arm) with a recommended interval of at least 2 years unless clinically contraindicated. Randomisation for participants with PSA relapse was stratified by type of previous therapy, relapse-free interval, and PSA doubling time; randomisation for those with non-curative disease was stratified by metastatic status; and randomisation in both groups was stratified by planned treatment schedule (continuous or intermittent) and treatment centre. Clinicians could prescribe any form and schedule of androgen-deprivation therapy and group assignment was not masked. The primary outcome was overall survival in the intention-to-treat population. The trial closed to accrual in 2012 after review by the independent data monitoring committee, but data collection continued for 18 months until Feb 26, 2014. It is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12606000301561) and ClinicalTrials.gov (NCT00110162). Findings Between Sept 3, 2004, and July 13, 2012, we recruited 293 men (261 with PSA relapse and 32 with non-curable disease). We randomly assigned 142 men to the immediate therapy arm and 151 to the delayed therapy arm. Median follow-up was 5 years (IQR 3·3–6·2) from the date of randomisation. 16 (11%) men died in the immediate therapy arm and 30 (20%) died in the delayed therapy arm. 5-year overall survival was 86·4% (95% CI 78·5–91·5) in the delayed therapy arm versus 91·2% (84·2–95·2) in the immediate therapy arm (log-rank p=0·047). After Cox regression, the unadjusted HR for overall survival for immediate versus delayed arm assignment was 0·55 (95% CI 0·30–1·00; p=0·050). 23 patients had grade 3 treatment-related adverse events. 105 (36%) men had adverse events requiring hospital admission; none of these events were attributable to treatment or differed between treatment-timing groups. The most common serious adverse events were cardiovascular, which occurred in nine (6%) patients in the delayed therapy arm and 13 (9%) in the immediate therapy arm. Interpretation Immediate receipt of androgen-deprivation therapy significantly improved overall survival compared with delayed intervention in men with PSA-relapsed or non-curable prostate cancer. The results provide benchmark evidence of survival rates and morbidity to discuss with men when considering their treatment options. Funding Australian National Health and Medical Research Council and Cancer Councils, The Royal Australian and New Zealand College of Radiologists, Mayne Pharma Australia.

Changing risk behaviours for non-communicable disease in New Zealand working men - is workplace intervention effective?

Aims. To evaluate the effectiveness of a health promotion
programme targeting dietary behaviours and physical
activity among male hourly-paid workers and to explore
demographic and attitudinal influences on dietary patterns
at baseline.
Methods. A controlled field trial compared workers at one
intervention and one control worksite. The intervention
comprised nutrition displays in the cafeteria and monthly
30-minute workshops for six months. Key outcome
measures at six and twelve-months were self-reported
dietary and lifestyle behaviours, nutrition knowledge, body
mass index (BMI), waist circumference and blood pressure.
Results. 132 men at the intervention site and 121 men at the
control site participated in the study and a high retention rate
(94% at 6-months and 89% at 12-months) was achieved. At
baseline, 40% of the total sample (253) were obese, 30% had
elevated blood pressure, 59% indicated an excessive fat intake
and 92% did not meet the recommended vegetable and fruit
intake. The intervention reduced fat intake, increased
vegetable intake and physical activity, improved nutrition
knowledge and reduced systolic blood pressure when
compared to the control site. There was no difference in
change in mean BMI or waist circumference. Reduction in
BMI was associated with reduction in fat intake.
Discussion. Low intensity workplace intervention can
significantly improve reported health behaviours and
nutrition knowledge although the impact on more
objective measures of risk was variable. A longer duration
or more intensive intervention may be required to achieve
further reduction in risk factors.

Programs for men who perpetrate domestic violence : an examination of the issues underlying the effectiveness of intervention programs

This review paper seeks to explore some of the reasons why rehabilitation programs for male perpetrators of domestic violence appear to be less effective in reducing recidivism than programs for other offender groups. It is argued that while the model of systems response to domestic violence has predominated at the inter-agency level, further consideration might be given to way in which men’s intervention groups are both designed and delivered. It is concluded that the program logic of men’s domestic violence programs is rarely articulated leading to low levels of program integrity, and that one way to further improve program effectiveness is to incorporate some of the approaches evident in more general violence prevention programs and from what is know about good practice in general about offender rehabilitation.

Three-month bilateral hopping intervention is ineffective in initiating bone biomarker response in healthy elderly men.

In animal studies, bone adaptation has been initiated successfully without the transient force spike associated with high impact exercises. Consequently, a 12-week bilateral hopping on the balls of the feet intervention was conducted. 25 elderly men (age 72(SD4) years, height 171(6) cm, weight 75(9) kg) were randomly assigned into exercise and control groups. Ten subjects in each group completed the study. Carboxyterminal propeptide of type I collagen (CICP), bone-specific alkaline phosphatase (bALP) and carboxyterminal telopeptide of type I collagen (CTx) were measured from venous blood samples at baseline, at 2 weeks and at the end of the intervention. Maximal ground reaction force (GRF), osteogenic index (OI) and jump height (JH) were determined from bilateral hopping test and balance was assessed with velocity of center of pressure (COPvelocity) while standing on the preferred leg with eyes open. The intervention consisted of 5–7 sets of 10 s timed bilateral hopping exercise at 75–90% intensity three times/week. There was no significant group 9 time interaction for GRF, OI and JH (P = 0.065). GRF (11% change from baseline vs. 4%), OI (15 vs. 6%) and COPvelocity (-10 vs. -1%) were not influenced by the intervention (P[0.170), while the control group improved JH (P = 0.031) (2 vs. 18%). For the biomarkers, no effect was observed in MANOVA (P = 0.536) or in univariate analyses (P = 0.082 to P = 0.820) (CICP -2 vs. -3%, CTx 8 vs. -12%, bALP 0 vs. -3.7%). Allowing transient impact force spikes may be necessary to initiate a bone response in elderly men as the intervention was ineffective.

Preliminary results of a randomised controlled trial of an online psychological intervention to reduce distress in men treated for localised prostate cancer

Prostate cancer (PCa) poses many emotional and physical challenges for men following treatment. The unmet support needs of these men are well documented, and access to psychosocial support remains problematic.

Nurse-led group consultation intervention reduces depressive symptoms in men with localised prostate cancer: a cluster randomised controlled trial

BACKGROUND: Radiotherapy for localised prostate cancer has many known and distressing side effects. The efficacy of group interventions for reducing psychological morbidity is lacking. This study investigated the relative benefits of a group nurse-led intervention on psychological morbidity, unmet needs, treatment-related concerns and prostate cancer-specific quality of life in men receiving curative intent radiotherapy for prostate cancer.

METHODS: This phase III, two-arm cluster randomised controlled trial included 331 men (consent rate: 72 %; attrition: 5 %) randomised to the intervention (n = 166) or usual care (n = 165). The intervention comprised four group and one individual consultation all delivered by specialist uro-oncology nurses. Primary outcomes were anxious and depressive symptoms as assessed by the Hospital Anxiety and Depression Scale. Unmet needs were assessed with the Supportive Care Needs Survey-SF34 Revised, treatment-related concerns with the Cancer Treatment Scale and quality of life with the Expanded Prostate Cancer Index -26. Assessments occurred before, at the end of and 6 months post-radiotherapy. Primary outcome analysis was by intention-to-treat and performed by fitting a linear mixed model to each outcome separately using all observed data.

RESULTS: Mixed models analysis indicated that group consultations had a significant beneficial effect on one of two primary endpoints, depressive symptoms (p = 0.009), and one of twelve secondary endpoints, procedural concerns related to cancer treatment (p = 0.049). Group consultations did not have a significant beneficial effect on generalised anxiety, unmet needs and prostate cancer-specific quality of life.

CONCLUSIONS: Compared with individual consultations offered as part of usual care, the intervention provides a means of delivering patient education and is associated with modest reductions in depressive symptoms and procedural concerns. Future work should seek to confirm the clinical feasibility and cost-effectiveness of group interventions.

Evaluation of interventions for gay men: two desiderata

This paper was presented in a session at the AIDS Impact conference devoted to a debate on the methods that should be used to evaluate educational interventions. The paper highlights two desiderata for evaluation of interventions directed at gay men. First, the view is presented that there is no acceptable substitute for assessing the effect of an intervention on gay men's sexual behaviour (rather than, for example, their AIDS-related attitudes or beliefs). This view is justified in terms of (a) the differences that exist between AIDS-related thinking in the cold light of day and during actual sexual encounters; and (b) the often faulty nature of intuitions about the factors that contribute to sexual risk-taking and the ways in which it might be reduced. Second, it is argued that the randomized control study design represents the best means for ensuring that interventions will be as effective as possible. Criticisms which have been made of this design are discussed and the conclusion drawn that they do not amount to a strong case against it.

Lupin kernel fibre-enriched foods beneficially modify serum lipids in men

Objective: To examine the effect of a diet containing a novel legume food ingredient, Australian sweet lupin (Lupinus angustifolius) kernel fibre (LKFibre), compared to a control diet without the addition of LKFibre, on serum lipids in men.

Design: Randomized crossover dietary intervention study.

Setting: Melbourne, Australia — Free-living men.

Subjects: A total of 38 healthy males between the ages of 24 and 64 y completed the intervention.

Intervention: Subjects consumed an LKFibre and a control diet for 1 month each. Both diets had the same background menus with seven additional experimental foods that either contained LKFibre or did not. Depending on energy intake, the LKFibre diet was designed to contain an additional 17 to 30 g/day fibre beyond that of the control diet.

Results: Compared to the control diet, the LKFibre diet reduced total cholesterol (TC) (meanplusminuss.e.m.; 4.5plusminus1.7%; P=0.001), low-density lipoprotein cholesterol (LDL-C) (5.4plusminus2.2%; P=0.001), TC: high-density lipoprotein cholesterol (HDL-C) (3.0plusminus2.0%; P=0.006) and LDL-C:HDL-C (3.8plusminus2.6%; P=0.003). No effects on HDL-C, triacylglycerols, glucose or insulin were observed.

Conclusions: Addition of LKFibre to the diet provided favourable changes to some serum lipid measures in men, which, combined with its high palatability, suggest this novel ingredient may be useful in the dietary reduction of coronary heart disease risk.

Lupin kernel fiber consumption modifies fecal microbiota in healthy men as determined by rRNA gene flourescent in situ by hybridization

Background Changes in the composition of gastrointestinal microbiota by dietary interventions using pro- and prebiotics provide opportunity for improving health and preventing disease. However, the capacity of lupin kernel fiber (LKFibre), a novel legume-derived food ingredient, to act as a prebiotic and modulate the colonic microbiota in humans needed investigation.

Aim of the study The present study aimed to determine the effect of LKFibre on human intestinal microbiota by quantitative fluorescent in situ hybridization (FISH) analysis.

Design A total of 18 free-living healthy males between the ages of 24 and 64 years consumed a control diet and a LKFibre diet (containing an additional 17–30 g/day fiber beyond that of the control—incorporated into daily food items) for 28 days with a 28-day washout period in a single-blind, randomized, crossover dietary intervention design.
Methods Fecal samples were collected for 3 days towards the end of each diet and microbial populations analyzed by FISH analysis using 16S rRNA gene-based oligonucleotide probes targeting total and predominant microbial populations.

Results Significantly higher levels of Bifidobacterium spp. (P = 0.001) and significantly lower levels of the clostridia group of C. ramosum, C. spiroforme and C. cocleatum (P = 0.039) were observed on the LKFibre diet compared with the control. No significant differences between the LKFibre and the control diet were observed for total bacteria, Lactobacillus spp., the Eubacterium spp., the C. histolyticum/C. lituseburense group and the Bacteroides–Prevotella group.
Conclusions Ingestion of LKFibre stimulated colonic bifidobacteria growth, which suggests that this dietary fiber may be considered as a prebiotic and may beneficially contribute to colon health.

Randomised controlled trial evaluating the effectiveness of behavioural interventions to modify cardiovascular risk factors in men and women with imparied glucose tolerance: outcomes at 6 months

Aims: To evaluate the efficacy of interventions to promote a healthy diet and physical activity in people with impaired glucose tolerance (IGT). Methods: A randomised controlled trial in Newcastle upon Tyne, UK, 1995–98. Participants included 67 adults (38 men; 29 women) aged 24–75 years with IGT. The intervention consisted of regular diet and physical activity counselling based on the stages of change model. Main outcome measures were changes between baseline and 6 months in nutrient intake; physical activity; anthropometric and physiological measurements including serum lipids; glucose tolerance; insulin sensitivity. Results: The difference in change in total fat consumption was significant between intervention and control groups (difference −21.8 (95% confidence interval (CI) −37.8 to −5.8) g/day, P=0.008). A significantly larger proportion of intervention participants reported taking up vigorous activity than controls (difference 30.1, (95% CI 4.3–52.7)%, P=0.021). The change in body mass index was significantly different between groups (difference −0.95 (95% CI −1.5 to −0.4) kg/m2, P=0.001). There was no significant difference in change in mean 2-h plasma glucose between groups (difference −0.19 (95% CI −1.1 to 0.71) mmol/l, NS) or in serum cholesterol (difference 0.02 (95% CI −0.26 to 0.31) mmol/l, NS). The difference in change in fasting serum insulin between groups was significant (difference −3.4 (95% CI −5.8 to −1.1) mU/l, P=0.005). Conclusions: After 6 months of intensive lifestyle intervention in participants with IGT, there were changes in diet and physical activity, some cardiovascular risk factors and insulin sensitivity, but not glucose tolerance. Further follow-up is in progress to investigate whether these changes are sustained or augmented over 2 years.