ObjectivesInterventions designed to improve men’s diet and physical activity (PA) have been recommended as methods of cancer prevention. However, little is known about specific factors that support ...men’s adherence to these health behaviour changes, which could inform theory-led diet and PA interventions. We aimed to explore these factors in men following prostatectomy for prostate cancer (PCa).Design, setting and participantsA qualitative study using semistructured interviews with men, who made changes to their diet and/or PA as part of a factorial randomised controlled trial conducted at a single hospital in South West England. Participants were 17 men aged 66 years, diagnosed with localised PCa and underwent prostatectomy. Interview transcripts underwent thematic analysis.ResultsMen were ambivalent about the relationship of nutrition and PA with PCa risk. They believed their diet and level of PA were reasonable before being randomised to their interventions. Men identified several barriers and facilitators to performing these new behaviours. Barriers included tolerance to dietary changes, PA limitations and external obstacles. Facilitators included partner involvement in diet, habit formation and brisk walking as an individual activity. Men discussed positive effects associated with brisk walking, such as feeling healthier, but not with nutrition interventions.ConclusionsThe facilitators to behaviour change suggest that adherence to trial interventions can be supported using well-established behaviour change models. Future studies may benefit from theory-based interventions to support adherence to diet and PA behaviour changes in men diagnosed with PCa.
Lower urinary tract symptoms (LUTS) are a common urological complaint. Transgender and gender diverse (TGD) individuals who have undergone masculinising or feminising genital gender-affirmation ...surgery (gGAS) experience a higher incidence of LUTS. Clinical assessment of LUTS involves symptom questionnaires, which are often gender-binary, and intimate examinations, which can be a source of distress if conducted without appropriate care. Inadequate clinical knowledge of complex anatomy following gGAS can cause further patient discomfort. Urodynamic studies often form an integral part of a urological assessment. These involve multichannel catheterisation. If performed by an inexperienced clinician, this can be a risky procedure for those who have undergone masculinising gGAS, as the reconstructed urethra is more fragile, tortuous and stenosed. The potential consequences of perforation are grave, risking the compromise of the functional and aesthetic outcomes of the original procedure. With this in mind, we highlight key areas during the investigation of LUTS where specific considerations for ensuring TGD inclusivity could be made.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background Evidence from observational studies have shown that moderate intensity physical activity can reduce risk of progression and cancer-specific mortality in participants with prostate cancer. ...Epidemiological studies have also shown participants taking metformin to have a reduced risk of prostate cancer. However, data from randomised controlled trials supporting the use of these interventions are limited. The Prostate cancer-Exercise and Metformin Trial examines that feasibility of randomising participants diagnosed with localised or locally advanced prostate cancer to interventions that modify physical activity and blood glucose levels. The primary outcomes are randomisation rates and adherence to the interventions over 6 months. The secondary outcomes include intervention tolerability and retention rates, measures of insulin-like growth factor I, prostate-specific antigen, physical activity, symptom-reporting, and quality of life. Methods Participants are randomised in a 2 x 2 factorial design to both a physical activity (brisk walking or control) and a pharmacological (metformin or control) intervention. Participants perform the interventions for 6 months with final measures collected at 12 months follow-up. Discussion Our trial will determine whether participants diagnosed with localised or locally advanced prostate cancer, who are scheduled for radical treatments or being monitored for signs of cancer progression, can be randomised to a 6 months physical activity and metformin intervention. The findings from our trial will inform a larger trial powered to examine the clinical benefits of these interventions. Trial registration Prostate Cancer Exercise and Metformin Trial (Pre-EMpT) is registered on the ISRCTN registry, reference number ISRCTN13543667. Date of registration 2nd August 2018-retrospectively registered. First participant was recruited on 11th September 2018. Keywords: Prostate cancer, Metformin, Physical activity, Feasibility randomised controlled trial, Localised, Locally advanced, Radiotherapy, Prostatectomy, Active surveillance
Lifestyle factors, including diet and physical activity, are associated with prostate cancer progression and mortality. However, it is unclear how men would like lifestyle information to be delivered ...following primary treatment. This study aimed to identify men's preferences for receiving lifestyle information.
We conducted a cross-sectional pilot best-worst discrete choice experiment which was nested within a feasibility randomised controlled trial. Our aim was to explore men's preferences of receiving diet and physical activity advice following surgery for localised prostate cancer. Thirty-eight men with a mean age of 65 years completed best-worst scenarios based on four attributes: (1) how information is provided; (2) where information is provided; (3) who provides information; and (4) the indirect cost of receiving information. Data was analysed using conditional logistic regression. Men's willingness to pay (WTP) for aspects of the service was calculated using an out-of-pocket cost attribute.
The combined best-worst analysis suggested that men preferred information through one-to-one discussion
= 1.07, CI = 0.88 to 1.26) and not by email (
= - 1.02, CI = - 1.23 to - 0.80). They preferred information provided by specialist nurses followed by dietitians (
= 0.76, CI = 0.63 to 0.90 and - 0.16, CI = - 0.27 to - 0.05 respectively) then general nurses (
= - 0.60, CI = - 0.73 to - 0.48). Three groups were identified based on their preferences. The largest group preferred information through individual face-to-face or group discussions (
= 1.35, CI = 1.05 to 1.63 and 0.70, CI = 0.38 to 1.03 respectively). The second group wanted information via one-to-one discussions or telephone calls (
= 1.89, CI = 1.41 to 2.37 and 1.03, CI = 0.58 to 1.48 respectively), and did not want information at community centres (
= - 0.50, CI = - 0.88 to - 0.13). The final group preferred individual face-to-face discussions (
= 0.45, CI = 0.03 to 0.88) but had a lower WTP value (£17).
Men mostly valued personalised methods of receiving diet and physical activity information over impersonal methods. The out-of-pocket value of receiving lifestyle information was important to some men. These findings could help inform future interventions using tailored dietary and physical activity advice given to men by clinicians following treatment for prostate cancer, such as mode of delivery, context, and person delivering the intervention. Future studies should consider using discrete choice experiments to examine information delivery to cancer survivor populations.
IMPORTANCE: Robot-assisted radical cystectomy is being performed with increasing frequency, but it is unclear whether total intracorporeal surgery improves recovery compared with open radical ...cystectomy for bladder cancer. OBJECTIVES: To compare recovery and morbidity after robot-assisted radical cystectomy with intracorporeal reconstruction vs open radical cystectomy. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial of patients with nonmetastatic bladder cancer recruited at 9 sites in the UK, from March 2017-March 2020. Follow-up was conducted at 90 days, 6 months, and 12 months, with final follow-up on September 23, 2021. INTERVENTIONS: Participants were randomized to receive robot-assisted radical cystectomy with intracorporeal reconstruction (n = 169) or open radical cystectomy (n = 169). MAIN OUTCOMES AND MEASURES: The primary outcome was the number of days alive and out of the hospital within 90 days of surgery. There were 20 secondary outcomes, including complications, quality of life, disability, stamina, activity levels, and survival. Analyses were adjusted for the type of diversion and center. RESULTS: Among 338 randomized participants, 317 underwent radical cystectomy (mean age, 69 years; 67 women 21%; 107 34% received neoadjuvant chemotherapy; 282 89% underwent ileal conduit reconstruction); the primary outcome was analyzed in 305 (96%). The median number of days alive and out of the hospital within 90 days of surgery was 82 (IQR, 76-84) for patients undergoing robotic surgery vs 80 (IQR, 72-83) for open surgery (adjusted difference, 2.2 days 95% CI, 0.50-3.85; P = .01). Thromboembolic complications (1.9% vs 8.3%; difference, –6.5% 95% CI, –11.4% to –1.4%) and wound complications (5.6% vs 16.0%; difference, –11.7% 95% CI, –18.6% to –4.6%) were less common with robotic surgery than open surgery. Participants undergoing open surgery reported worse quality of life vs robotic surgery at 5 weeks (difference in mean European Quality of Life 5-Dimension, 5-Level instrument scores, –0.07 95% CI, –0.11 to –0.03; P = .003) and greater disability at 5 weeks (difference in World Health Organization Disability Assessment Schedule 2.0 scores, 0.48 95% CI, 0.15-0.73; P = .003) and at 12 weeks (difference in WHODAS 2.0 scores, 0.38 95% CI, 0.09-0.68; P = .01); the differences were not significant after 12 weeks. There were no statistically significant differences in cancer recurrence (29/161 18% vs 25/156 16% after robotic and open surgery, respectively) and overall mortality (23/161 14.3% vs 23/156 14.7%), respectively) at median follow-up of 18.4 months (IQR, 12.8-21.1). CONCLUSIONS AND RELEVANCE: Among patients with nonmetastatic bladder cancer undergoing radical cystectomy, treatment with robot-assisted radical cystectomy with intracorporeal urinary diversion vs open radical cystectomy resulted in a statistically significant increase in days alive and out of the hospital over 90 days. However, the clinical importance of these findings remains uncertain. TRIAL REGISTRATION: ISRCTN Identifier: ISRCTN13680280; ClinicalTrials.gov Identifier: NCT03049410
Three main treatments are offered to men with localised prostate cancer: active monitoring, radiotherapy and prostatectomy. The aim of this research was to explore the role of body image in treatment ...decision-making and post-treatment regret following prostatectomy for localised prostate cancer. Data were collected via nine semi-structured interviews. Interviews underwent thematic analysis and four themes emerged: need to prolong life, loss of function and self, post-surgery effects on body image and confidence, and coping strategies. Participants revealed that loss of erectile function following surgery resulted in reduced self-confidence, and changes in their perception of their body.
There is increasing evidence that low levels of physical activity and diets low in fruit and vegetables and high in meat and dairy products are risk factors for prostate cancer disease progression. ...The Prostate cancer: Evidence of Exercise and Nutrition Trial (PrEvENT) aimed to assess a diet and physical activity intervention in men undergoing radical prostatectomy for localized prostate cancer. The trial included a qualitative component to explore the experiences of men participating in the trial in order to understand the acceptability of the intervention and data collection methods. We report the qualitative findings of the trial and consider how these can be used to inform future research.
PrEvENT involved randomizing men to either a dietary and/or physical activity intervention. Semi-structured interviews were conducted with a purposive sample of 17 men on completion of the 6 month trial. Interviews took place in clinic or as telephone interviews, if requested by the participant, and were audio recorded, transcribed, and analyzed using the thematic-based framework approach. Analysis was conducted throughout the data collection process to allow emergent themes to be further explored in subsequent interviews.
Three overarching themes were identified: acceptability of the intervention, acceptability of the data collection methods and trial logistics. Participants were predominantly positive about both the dietary and physical activity interventions and most men found the methods of data collection appropriate. Recommendations for future trials include consideration of alternative physical activity options, such as cycling or gym sessions, increased information on portion sizes, the potential importance of including wives or partners in the dietary change process and the possibility of using the pedometer or other wearable technology as part of the physical activity intervention.
We provide insight into the opinions and experiences of the acceptability of the PrEvENT diet and physical activity intervention from the participants themselves. The interventions delivered were acceptable to this sample of participants, as were the data collection methods utilized. We also highlight some considerations for further behavioural change interventions in prostate cancer and other similar populations.
ISRCTN, ISRCTN99048944 . Registered on 17 November 2014.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
ObjectiveDietary factors and physical activity may alter prostate cancer progression. We explored the feasibility of lifestyle interventions following radical prostatectomy for localised prostate ...cancer.DesignPatients were recruited into a presurgical observational cohort; following radical prostatectomy, they were offered randomisation into a 2×3 factorial randomised controlled trial (RCT).SettingA single National Health Service trust in the South West of England, UK.ParticipantsThose with localised prostate cancer and listed for radical prostatectomy were invited to participate.RandomisationRandom allocation was performed by the Bristol Randomised Trial Collaboration via an online system.InterventionsMen were randomised into both a modified nutrition group (either increased vegetable and fruit, and reduced dairy milk; or lycopene supplementation; or control) and a physical activity group (brisk walking or control) for 6 months.BlindingOnly the trial statistician was blind to allocations.Primary outcome measuresPrimary outcomes were measures of feasibility: randomisation rates and intervention adherence at 6 months. Collected at trial baseline, three and six months, with daily adherence reported throughout. Our intended adherence rate was 75% or above, the threshold for acceptable adherence was 90%.Results108 men entered the presurgical cohort, and 81 were randomised into the postsurgical RCT (randomisation rate: 93.1%) and 75 completed the trial. Of 25 men in the nutrition intervention, 10 (40.0%; 95% CI 23.4% to 59.3%) adhered to the fruit and vegetable recommendations and 18 (72.0%; 95% CI 52.4% to 85.7%) to reduced dairy intake. Adherence to lycopene (n=28), was 78.6% (95% CI 60.5% to 89.8%), while 21/39 adhered to the walking intervention (53.8%; 95% CI 38.6% to 68.4%). Most men were followed up at 6 months (75/81; 92.6%). Three ‘possibly related’ adverse events were indigestion, abdominal bloating and knee pain.ConclusionsInterventions were deemed feasible, with high randomisation rates and generally good adherence. A definitive RCT is proposed.Trial registration numberISRCTN 99048944.
The value to payers of robot-assisted radical cystectomy with intracorporeal urinary diversion (iRARC) when compared with open radical cystectomy (ORC) for patients with bladder cancer is unclear.
To ...compare the cost-effectiveness of iRARC with that of ORC.
This economic evaluation used individual patient data from a randomized clinical trial at 9 surgical centers in the United Kingdom. Patients with nonmetastatic bladder cancer were recruited from March 20, 2017, to January 29, 2020. The analysis used a health service perspective and a 90-day time horizon, with supplementary analyses exploring patient benefits up to 1 year. Deterministic and probabilistic sensitivity analyses were undertaken. Data were analyzed from January 13, 2022, to March 10, 2023.
Patients were randomized to receive either iRARC (n = 169) or ORC (n = 169).
Costs of surgery were calculated using surgery timings and equipment costs, with other hospital data based on counts of activity. Quality-adjusted life-years were calculated from European Quality of Life 5-Dimension 5-Level instrument responses. Prespecified subgroup analyses were undertaken based on patient characteristics and type of diversion.
A total of 305 patients with available outcome data were included in the analysis, with a mean (SD) age of 68.3 (8.1) years, and of whom 241 (79.0%) were men. Robot-assisted radical cystectomy was associated with statistically significant reductions in admissions to intensive therapy (6.35% 95% CI, 0.42%-12.28%), and readmissions to hospital (14.56% 95% CI, 5.00%-24.11%), but increases in theater time (31.35 95% CI, 13.67-49.02 minutes). The additional cost of iRARC per patient was £1124 (95% CI, -£576 to £2824 US $1622 (95% CI, -$831 to $4075)) with an associated gain in quality-adjusted life-years of 0.01124 (95% CI, 0.00391-0.01857). The incremental cost-effectiveness ratio was £100 008 (US $144 312) per quality-adjusted life-year gained. Robot-assisted radical cystectomy had a much higher probability of being cost-effective for subgroups defined by age, tumor stage, and performance status.
In this economic evaluation of surgery for patients with bladder cancer, iRARC reduced short-term morbidity and some associated costs. While the resulting cost-effectiveness ratio was in excess of thresholds used by many publicly funded health systems, patient subgroups were identified for which iRARC had a high probability of being cost-effective.
ClinicalTrials.gov Identifier: NCT03049410.
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