Suzanne K. Chambers

Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study.

BACKGROUND The absence of trial data comparing robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy is a crucial knowledge gap in uro-oncology. We aimed to compare these two approaches in terms of functional and oncological outcomes and report the early postoperative outcomes at 12 weeks. METHOD In this randomised controlled phase 3 study, men who had newly diagnosed clinically localised prostate cancer and who had chosen surgery as their treatment approach, were able to read and speak English, had no previous history of head injury, dementia, or psychiatric illness or no other concurrent cancer, had an estimated life expectancy of 10 years or more, and were aged between 35 years and 70 years were eligible and recruited from the Royal Brisbane and Womens Hospital (Brisbane, QLD). Participants were randomly assigned (1:1) to receive either robot-assisted laparoscopic prostatectomy or radical retropubic prostatectomy. Randomisation was computer generated and occurred in blocks of ten. This was an open trial; however, study investigators involved in data analysis were masked to each patients condition. Further, a masked central pathologist reviewed the biopsy and radical prostatectomy specimens. Primary outcomes were urinary function (urinary domain of EPIC) and sexual function (sexual domain of EPIC and IIEF) at 6 weeks, 12 weeks, and 24 months and oncological outcome (positive surgical margin status and biochemical and imaging evidence of progression at 24 months). The trial was powered to assess health-related and domain-specific quality of life outcomes over 24 months. We report here the early outcomes at 6 weeks and 12 weeks. The per-protocol populations were included in the primary and safety analyses. This trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), number ACTRN12611000661976. FINDINGS Between Aug 23, 2010, and Nov 25, 2014, 326 men were enrolled, of whom 163 were randomly assigned to radical retropubic prostatectomy and 163 to robot-assisted laparoscopic prostatectomy. 18 withdrew (12 assigned to radical retropubic prostatectomy and six assigned to robot-assisted laparoscopic prostatectomy); thus, 151 in the radical retropubic prostatectomy group proceeded to surgery and 157 in the robot-assisted laparoscopic prostatectomy group. 121 assigned to radical retropubic prostatectomy completed the 12 week questionnaire versus 131 assigned to robot-assisted laparoscopic prostatectomy. Urinary function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery (74·50 vs 71·10; p=0·09) or 12 weeks post-surgery (83·80 vs 82·50; p=0·48). Sexual function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery (30·70 vs 32·70; p=0·45) or 12 weeks post-surgery (35·00 vs 38·90; p=0·18). Equivalence testing on the difference between the proportion of positive surgical margins between the two groups (15 [10%] in the radical retropubic prostatectomy group vs 23 [15%] in the robot-assisted laparoscopic prostatectomy group) showed that equality between the two techniques could not be established based on a 90% CI with a Δ of 10%. However, a superiority test showed that the two proportions were not significantly different (p=0·21). 14 patients (9%) in the radical retropubic prostatectomy group versus six (4%) in the robot-assisted laparoscopic prostatectomy group had postoperative complications (p=0·052). 12 (8%) men receiving radical retropubic prostatectomy and three (2%) men receiving robot-assisted laparoscopic prostatectomy experienced intraoperative adverse events. INTERPRETATION These two techniques yield similar functional outcomes at 12 weeks. Longer term follow-up is needed. In the interim, we encourage patients to choose an experienced surgeon they trust and with whom they have rapport, rather than a specific surgical approach. FUNDING Cancer Council Queensland.

Predictors of change in unmet supportive care needs in cancer

Objective: Patient Reported Outcome (PRO) assessments can assist health professionals to tailor their health practices to the individual needs of patients and improve patient care over time. The present study assessed prospective predictors of unmet supportive care needs in cancer patients over a six‐month period.

A systematic review of psychosocial interventions for men with prostate cancer and their partners

OBJECTIVE To systematically review interventions aiming to improve adjustment in men with prostate cancer and their partners. METHODS Medline, EMBASE, CINAHL and PsycINFO databases were searched. Inclusion criteria were: randomized controlled trials; relevant to specified clinical questions; included men who had prostate cancer (at least 80% prostate cancer patients or prostate cancer sub-group analysis); published in English between December 1999 and December 2009. Trial quality was assessed. RESULTS 21 studies met inclusion criteria. Trial quality was low; had not improved over the study timeframe; men with advanced disease were not targeted; minority groups were seldom included. Group cognitive-behavioral and psycho-education interventions appear helpful in promoting better psychological adjustment and QOL for men with prostate cancer; coping skills training for patient-spouse dyads improved QOL for partners. CONCLUSION There are limitations in the research on effective ways to improve adjustment for men with prostate cancer of any stage and their partners; and scant research targeting minority groups and the concerns of men with advanced disease. PRACTICE IMPLICATIONS Interventions for men with advanced prostate cancer could usefully target the implications of advancing disease and caregiver burden. There is an urgent need for researchers to focus efforts specifically on such men and their families.

A systematic review of the impact of stigma and nihilism on lung cancer outcomes

BackgroundThis 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.MethodsMedline, 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.ResultsEighteen 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.ConclusionsHealth-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.

Can supervised exercise prevent treatment toxicity in patients with prostate cancer initiating androgen-deprivation therapy: a randomised controlled trial

To determine if supervised exercise minimises treatment toxicity in patients with prostate cancer initiating androgen‐deprivation therapy (ADT). This is the first study to date that has investigated the potential role of exercise in preventing ADT toxicity rather than recovering from established toxicities.

A multicentre year-long randomised controlled trial of exercise training targeting physical functioning in men with prostate cancer previously treated with androgen suppression and radiation from TROG 03.04 RADAR.

BACKGROUND Long-term prostate cancer (PCa) survivors are at increased risk for comorbidities and physical deconditioning. OBJECTIVE To determine the effectiveness of a year-long randomised controlled trial of exercise training in PCa survivors >5 yr postdiagnosis on physical functioning. DESIGN, SETTING, AND PARTICIPANTS Between 2010 and 2011, 100 long-term PCa survivors from Trans-Tasman Radiation Oncology Group 03.04 Randomised Androgen Deprivation and Radiotherapy previously treated with androgen-deprivation therapy and radiation therapy were randomly assigned to 6 mo of supervised exercise followed by 6 mo of a home-based maintenance programme (n=50) or printed educational material about physical activity (n=50) for 12 mo across 13 university-affiliated exercise clinics in Australia and New Zealand. INTERVENTION Supervised resistance and aerobic exercise or printed educational material about physical activity. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary end point was a 400-m walk as a measure of cardiovascular fitness. Secondary end points were physical function, patient-reported outcomes, muscle strength, body composition, and biomarkers. Analysis of covariance was used to compare outcomes for groups at 6 and 12 mo adjusted for baseline values. RESULTS AND LIMITATIONS Participants undergoing supervised exercise showed improvement in cardiorespiratory fitness performance at 6 mo (-19 s [p=0.029]) and 12 mo (-13 s [p=0.028]) and better lower-body physical function across the 12-mo period (p<0.01). Supervised exercise also improved self-reported physical functioning at 6 (p=.006) and 12 mo (p=0.002), appendicular skeletal muscle at 6 mo (p=0.019), and objective measures of muscle strength at 6 and 12 mo (p<0.050). Limitations included the restricted number of participants undertaking body composition assessment, no blinding to group assignment for physical functioning measures, and inclusion of well-functioning individuals. CONCLUSIONS Supervised exercise training in long-term PCa survivors is more effective than physical activity educational material for increasing cardiorespiratory fitness, physical function, muscle strength, and self-reported physical functioning at 6 mo. Importantly, these benefits were maintained in the long term with a home-based programme with follow-up at 12 mo. CLINICAL TRIAL REGISTRY The effect of an exercise intervention on cardiovascular and metabolic risk factors in prostate cancer patients from the RADAR study, ACTRN: ACTRN12609000729224.

Effects of a Telephone-Delivered Multiple Health Behavior Change Intervention (CanChange) on Health and Behavioral Outcomes in Survivors of Colorectal Cancer: A Randomized Controlled Trial

PURPOSE Colorectal cancer survivors are at risk for poor health outcomes because of unhealthy lifestyles, but few studies have developed translatable health behavior change interventions. This study aimed to determine the effects of a telephone-delivered multiple health behavior change intervention (CanChange) on health and behavioral outcomes among colorectal cancer survivors. METHODS In this two-group randomized controlled trial, 410 colorectal cancer survivors were randomly assigned to the health coaching intervention (11 theory-based telephone-delivered health coaching sessions delivered over 6 months focusing on physical activity, weight management, dietary habits, alcohol, and smoking) or usual care. Assessment of primary (ie, physical activity [Godin Leisure Time Index], health-related quality of life [HRQoL; Short Form-36], and cancer-related fatigue [Functional Assessment of Chronic Illness Therapy Fatigue Scale]) and secondary outcomes (ie, body mass index [kg/m(2)], diet and alcohol intake [Food Frequency Questionnaire], and smoking) were conducted at baseline and 6 and 12 months. RESULTS At 12 months, significant intervention effects were observed for moderate physical activity (28.5 minutes; P = .003), body mass index (-0.9 kg/m(2); P = .001), energy from total fat (-7.0%; P = .006), and energy from saturated fat (-2.8%; P = .016). A significant intervention effect was reported for vegetable intake (0.4 servings per day; P = .001) at 6 months. No significant group differences were found at 6 or 12 months for HRQoL, cancer-related fatigue, fruit, fiber, or alcohol intake, or smoking. CONCLUSION The CanChange intervention was effective for improving physical activity, dietary habits, and body mass index in colorectal cancer survivors. The intervention is translatable through existing telephone cancer support and information services in Australia and other countries.

The Potential Role of Exercise in Neuro-Oncology

Patients with brain and other central nervous system cancers experience debilitating physical, cognitive, and emotional effects, which significantly compromise quality of life. Few efficacious pharmacological strategies or supportive care interventions exist to ameliorate these sequelae and patients report high levels of unmet needs in these areas. There is strong theoretical rationale to suggest exercise may be an effective intervention to aid in the management of neuro-oncological disorders. Clinical research has established the efficacy of appropriate exercise in counteracting physical impairments such as fatigue and functional decline, cognitive impairment, as well as psychological effects including depression and anxiety. While there is promise for exercise to enhance physical and psychosocial wellbeing of patients diagnosed with neurologic malignancies, these patients have unique needs and research is urgently required to explore optimal exercise prescription specific to these patients to maximize safety and efficacy. This perspective article is a discussion of potential rehabilitative effects of targeted exercise programs for patients with brain and other central nervous system cancers and highlights future research directions.

The Impact of Body Mass Index and Physical Activity on Mortality among Patients with Colorectal Cancer in Queensland, Australia

Background: Few studies have investigated the impact of body mass index (BMI) and physical activity (PA) on mortality among colorectal cancer (CRC) patients and the results are inconsistent. We aimed to examine the impact of these lifestyle factors on all-cause and disease-specific mortality. Methods: Population-based longitudinal study followed 1,825 patients diagnosed with stages I to III primary CRC during 2003 to 2004 in Queensland, Australia for 5 years. Sociodemographics and clinical characteristics were obtained via questionnaires and medical records. Results: Participants with some level of PA following diagnosis had 25% to 28% lower risk of all-cause mortality within 5 years of diagnosis than sedentary participants [insufficiently active: HR = 0.72, 95% CI = 0.57–0.91; sufficiently active: HR = 0.75 (0.60–0.94)]; however, the differential for CRC-specific mortality was not significant. Increases in PA from five to 12 months postdiagnosis was associated with reduced CRC-specific mortality by 32% to 36% (increase ≤ 2 hour per week: HR = 0.68 (0.48–0.97); increase > 2 hour per week: HR = 0.64 (0.44–0.93) and 31% for all-cause mortality (increase >2 hour per week: HR = 0.69 (0.50–0.94). Compared with participants with healthy BMI, significant higher mortality risk was observed in underweight patients (all-cause: HR = 2.29 (1.47–3.59); CRC: HR = 1.74 (1.00–3.04), although lower risk in overweight (all-cause: HR = 0.75 (0.61–0.94); CRC: HR = 0.75 (0.59–0.97) and no difference in obese. Excessive weight loss was associated with increased mortality risk by three-fold but no difference in those who gained weight. Conclusions: Protective effects of being physically active and increasing that activity underlines the importance of interventions to increase activity levels among people being diagnosed with CRC. Impact: Increased mortality risks associated with being underweight or having weight loss over time is an important indicator for which clinicians, patients, and support personnel can monitor. Cancer Epidemiol Biomarkers Prev; 20(7); 1410–20. ©2011 AACR.

The validity of the distress thermometer in prostate cancer populations

The Distress Thermometer (DT) is widely recommended for screening for distress after cancer. However, the validity of the DT in men with prostate cancer and over differing time points from diagnosis has not been well examined.