Potential mechanisms of multimodal prehabilitation effects on surgical complications: a narrative review.

Continuous advances in prehabilitation research over the past several decades have clarified its role in improving preoperative risk factors, yet the evidence demonstrating reduced surgical complications remains uncertain. Describing the potential mechanisms underlying prehabilitation and surgical complications represents an important opportunity to establish biological plausibility, develop targeted therapies, generate hypotheses for future research, and contribute to the rationale for implementation into the standard of care. In this narrative review, we discuss and synthesize the current evidence base for the biological plausibility of multimodal prehabilitation to reduce surgical complications. The goal of this review is to improve prehabilitation interventions and measurement by outlining biologically plausible mechanisms of benefit and generating hypotheses for future research. This is accomplished by synthesizing the available evidence for the mechanistic benefit of exercise, nutrition, and psychological interventions for reducing the incidence and severity of surgical complications reported by the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP). This review was conducted and reported in accordance with a quality assessment scale for narrative reviews. Findings indicate that prehabilitation has biological plausibility to reduce all complications outlined by NSQIP. Mechanisms for prehabilitation to reduce surgical complications include anti-inflammation, enhanced innate immunity, and attenuation of sympathovagal imbalance. Mechanisms vary depending on the intervention protocol and baseline characteristics of the sample. This review highlights the need for more research in this space while proposing potential mechanisms to be included in future investigations.

Preference-based versus randomized controlled trial in prostate cancer survivors: Comparison of recruitment, adherence, attrition, and clinical outcomes.

Introduction: Patients' unwillingness to be randomized to a mode of exercise may partly explain their poor recruitment, adherence, and attrition in randomized controlled trials (RCTs) of exercise in oncology. It is unknown whether a preference-based trial can improve recruitment, adherence, retention, and clinical outcomes compared to a RCT of the same exercise interventions. Objective: We assessed the effects of a 2-arm exercise preference trial on adherence and clinical outcomes compared to a similar 2-arm RCT in men with prostate cancer (PC). Methods: This was a two-arm preference-based trial of group-based training (GROUP) or home-based training (HOME). PC survivors on androgen deprivation therapy (ADT) who declined randomization to the RCT but chose to participate in a preference trial were recruited in four Canadian centers. All study participants engaged in aerobic and resistance training, 4-5 days weekly for 6 months, aiming for 150 minutes/week of moderate-to-vigorous physical activity. The primary outcomes were changes from baseline to 6 months in fatigue and functional endurance. Secondary outcomes were quality of life, physical fitness, body composition, blood markers, and adherence. Linear mixed models were used to assess the effects of HOME versus GROUP on primary outcomes. In pooled preference and RCT data, the selection effect (i.e., difference between those who were and were not willing to be randomized) and treatment effect (i.e., difference between GROUP and HOME) were estimated using linear regression. Results and conclusion: Fifty-four participants (mean [SD] age, 70.2 [8.6] years) were enrolled (GROUP n=17; HOME n=37). Comparable effects on primary and secondary outcomes were observed following GROUP or HOME in the preference-based trial. Adherence was similar between preference and RCT participants. However, attrition was higher in the RCT (50.0% vs. 27.8%, p= 0.04). Compared to GROUP, HOME was more effective in ameliorating fatigue (mean difference: +5.2, 95%CI=1.3 to 9.3 p=0.01) in pooled preference and RCT data. A preference-based trial results in comparable observed effects on clinical outcomes and adherence and lower attrition compared with a RCT of the same exercise interventions in PC survivors on ADT. Given the appeals of preference-based trials to study participants, additional studies are warranted. Clinical trial registration: clinicaltrials.gov, identifier (NCT03335631).

Process Evaluation of a Sport-Based Supportive Care Intervention for Testicular Cancer Survivors: A Mixed Methods Study.

Testicular cancer survivors report unmet supportive care needs that are associated with poorer physical and mental health, yet engagement in traditional supportive care is low. The Ball's in Your Court intervention was designed to engage testicular cancer survivors in supportive care by leveraging a community-based sport and exercise model. Age-appropriate, gender-sensitized, and disease specific elements were reflected in the intervention design, setting, content, and delivery. The intervention included five weekly health promotion sessions among a group of testicular cancer survivors. The purpose of this study was to explore the intervention's (i) feasibility and acceptability, (ii) effects on testicular cancer survivors' perceived health, and (iii) gain feedback for intervention refinement. A total of 10 testicular cancer survivors participated in the pilot and completed questionnaires on demographics, cancer history, perceived health, and physical activity behavior at baseline (pre-intervention) and perceived health and satisfaction with intervention components (post-intervention). Open-ended feedback surveys were collected after each weekly session and researcher field notes were recorded by three members of the study team. One month following the intervention, a focus group was conducted with intervention participants. All participants were satisfied with the intervention. Content analysis of the qualitative data supported intervention acceptability. Visual analysis conducted at the individual level indicated that perceived health either remained stable or improved from pre- to post-intervention. The Ball's in Your Court intervention provides a feasible and acceptable approach for the delivery of supportive care aimed at improving testicular cancer survivors' health and wellness. Recommendations for intervention refinement were provided and require future examination.

The Relationship Between Preoperative Physical Activity With American Society of Anesthesiologists Score and Postoperative Length of Stay in Patients Undergoing Radical Prostatectomy.

BACKGROUND: The relationship between preoperative physical activity (PA) and hospital length of stay (LOS) following radical prostatectomy (RP) is poorly understood. In addition, the relationship between PA and the American Society of Anesthesiologists Physical Status score (ASA PS), an established prognosticator of surgical risk, has not been studied. The authors assessed the relationship between leisure-time PA (LTPA), ASA PS, and LOS in individuals undergoing RP. METHODS: This retrospective cohort study was conducted using data from an institutional database. Ordinal logistic regression was used to assess the relationship between preoperative LTPA and physical status as indicated by the ASA PS. Binary logistic regression was used to assess the relationship between preoperative LTPA and LOS. RESULTS: A sample of 1064 participants were included in the analyses. The participants in the highest preoperative LTPA quartile had 45% reduced odds (P = .015) of a worse ASA PS classification compared with participants in the lowest quartile. The participants engaging in vigorous LTPA preoperatively had 35% lower odds (P = .014) of a >2-day LOS following RP compared with participants who were not engaging in preoperative vigorous LTPA. CONCLUSIONS: Our findings suggest that total and vigorous preoperative LTPA is associated with improved preoperative American Society of Anesthesiologists scores and LOS following RP, respectively.

A Pragmatic Non-Randomized Trial of Prehabilitation Prior to Cancer Surgery: Study Protocol and COVID-19-Related Adaptations.

BACKGROUND: Experimental data highlight the potential benefits and health system cost savings related to surgical prehabilitation; however, adequately powered randomized controlled trial (RCT) data remain nascent. Emerging prehabilitation services may be informed by early RCT data but can be limited in informing real-world program development. Pragmatic trials emphasize external validity and generalizability to understand and advise intervention development and implementation in clinical settings. This paper presents the methodology of a pragmatic prehabilitation trial to complement emerging phase III clinical trials and inform implementation strategies. METHODS: This is a pilot pragmatic clinical trial conducted in a large academic hospital in Toronto, Ontario, Canada to assess feasibility of clinical implementation and derive estimates of effectiveness. Feasibility data include program referral rates, enrolment and attrition, intervention adherence and safety, participant satisfaction, and barriers and facilitators to programming. The study aims to receive 150 eligible referrals for adult, English-speaking, preoperative oncology patients with an identified indication for prehabilitation (e.g., frailty, deconditioning, malnutrition, psychological distress). Study participants undergo a baseline assessment and shared-decision making regarding the intervention setting: either facility-based prehabilitation or home-based prehabilitation. In both scenarios, participants receive an individualized exercise prescription, stress-reduction psychological support, nutrition counseling, and protein supplementation, and if appropriate, smoking cessation program referrals. Secondary objectives include estimating intervention effects at the week prior to surgery and 30 and 90 days postoperatively. Outcomes include surgical complications, postoperative length of stay, mortality, hospital readmissions, physical fitness, psychological well-being, and quality of life. Data from participants who decline the intervention but consent for research-related access to health records will serve as comparators. The COVID-19 pandemic required the introduction of a 'virtual program' using only telephone or internet-based communication for screening, assessments, or intervention was introduced. CONCLUSION: This pragmatic trial will provide evidence on the feasibility and viability of prehabilitation services delivered under usual clinical conditions. Study amendments due to the COVID-19 pandemic are presented as strategies to maintain prehabilitation research and services to potentially mitigate the consequences of extended surgery wait times.

Sexual function and rehabilitation after radiation therapy for prostate cancer: a review.

The treatment of prostate cancer is partly guided by patient preferences. Radical prostatectomy and radiation therapy are the standard radical therapies for localized disease and render comparable oncologic outcomes. Considering that survival is high regardless of the chosen treatment, factors such as treatment-related toxicities affecting the patients' quality of life play an important role in their decision. Notably, post-treatment sexual dysfunction, which includes decreased libido, erectile dysfunction, and ejaculatory dysfunction has been shown to be an important and prevalent concern of prostate cancer survivors. In this literature review, we sought to characterize the sexual complications associated with radiation therapy and map the available sexual rehabilitation options for prostate cancer survivors experiencing sexual dysfunction as a result of radiation therapy. We identified medical, non-biomedical, counseling, and lifestyle modification options for prostate cancer survivors seeking sexual rehabilitation. Future research in this area should address the standardization of sexual side-effect reporting and investigate sexual outcomes and rehabilitation in more diverse groups and of transgender and nonheterosexual prostate cancer survivors.

Preferences for exercise and physical activity support in adolescent and young adult cancer survivors: a cross-sectional survey.

PURPOSE: Exercise and physical activity (hereafter, collectively referred to as PA) preferences and benefits are becoming increasingly well characterised in cancer survivors, yet evidence from adolescent and young adult cancer survivors (AYAs) is scant. We describe the overall PA behaviour and support preferences of AYAs and explore subgroup differences to inform AYA-specific research and support. METHODS: AYAs diagnosed with cancer between the ages of 18-39 years, irrespective of current age, were approached in clinic at a large cancer centre for this cross-sectional survey that assessed self-reported demographics, medical history, PA behaviour and PA support preferences. RESULTS: A total of 318 AYAs completed the survey. Approximately 40% of AYAs were not meeting PA guidelines, and only 5% reported engagement with cancer PA support services. Most AYAs wanted PA support (78%), to increase PA levels (70%), and were interested in engaging in PA interventions that were individually supervised (82%), home-based (79%), performed ≥ 3 days/week (75%) and for ≥ 30 minutes/session (78%), offered following treatment (63%), restricted by age (63%), and involved strength (83%), walking (78%), and flexibility (75%) exercise. PA preferences most often differed according to sex, treatment status, current PA behaviour and PA support setting. CONCLUSION: AYAs have a great capacity and interest in specific types of PA support. Poor engagement with existing PA support services highlights the need for further AYA-specific research. Better understanding of AYAs' unique PA behaviour and support preferences can inform the development of urgently needed research and support services for this understudied and rapidly growing population.

Associations between self-reported physical activity, quality of life, and emotional well-being in men with prostate cancer on active surveillance.

OBJECTIVE: The relationship between physical activity (PA) and quality of life (QOL) relative to active treatment for prostate cancer (PCa) has been well-studied; however, little is known about this relationship during active surveillance (AS). Moreover, whether PA is associated with better emotional well-being (EWB) in men with low-risk PCa requires further investigation. Accordingly, we examined the association between self-reported PA and the average change in QOL and EWB over time during AS. METHODS: A total of 630 men on AS were included in this retrospective, longitudinal study from AS initiation until AS discontinuation. Generalized estimated equations were used to determine the association between self-reported PA (independent variable) and QOL and EWB (dependent variables) over time, adjusting for participants' age. RESULTS: QOL was higher over time in active ( ß^ (95%CI) = 1.14 (0.11, 2.16), P = .029) and highly active participants ( ß^ (95%CI) = 1.62 (0.58, 2.67), P = .002) compared to their inactive counterparts. Highly active participants had 55% greater odds of experiencing high EWB relative to inactive participants (OR (95%CI) = 1.55 (1.11, 2.16), P = .010). In men with low EWB at baseline (median = 3 months after diagnosis), the highest levels of PA (>1000 metabolic equivalent-minutes per week) were associated with high EWB over time (OR (95%CI) = 2.17 (1.06, 4.46), P = .034). CONCLUSIONS: These data further support the importance of PA as a supportive care strategy for men on AS. Our findings suggest that engaging in higher volumes of PA post-diagnosis may be beneficial particularly for men exhibiting low emotional well-being early on during AS.

Pfilates and Hypopressives for the Treatment of Urinary Incontinence After Radical Prostatectomy: Results of a Feasibility Randomized Controlled Trial.

BACKGROUND: Urinary incontinence (UI) is an important side effect of radical prostatectomy (RP). Coactivation of surrounding muscles via novel techniques for pelvic floor rehabilitation known as Pfilates and Hypopressives has not been compared to pelvic floor muscle exercises (PFMXs) for UI. OBJECTIVE: To assess the feasibility and efficacy of isolated PFMXs with and without the addition of Pfilates and Hypopressives on UI recovery following RP. DESIGN: Randomized controlled trial. SETTING: Participants were recruited from a community and tertiary cancer center in Toronto, Canada. PARTICIPANTS: A total of 226 patients undergoing RP were assessed for eligibility. One hundred twenty-two patients were eligible and 50 consented to participate; 37 participants completed the trial. METHODS: Participants were randomized to either isolated PFMX (control) or PFMX plus Pfilates and Hypopressives (advanced pelvic floor exercises; APFX) groups. PFMX participants (n = 25) received instructions for isolated pelvic floor contractions starting with 30 contractions per day during weeks 1 to 2 up to 180 per day for weeks 7 to 26. The APFX group (n = 25) received a comparable volume of exercises. MAIN OUTCOME MEASUREMENTS: Feasibility was assessed by rates of recruitment, adverse events, and study-arm compliance. Information about UI and quality of life was collected 1 week before surgery and at 2, 6, 12, and 26 weeks after surgery. RESULTS: The recruitment rate was 41%, adherence to the PFMXs and APFXs was >70%, and there were no reported adverse events. Between-group differences were observed in the frequency of self-reported 24-hour urinary leakage (rate ratio 0.45, 95% confidence interval [CI] 0.2-0.98) and during waking hours (rate ratio 0.43, 95% CI 0.20-0.91) at 26 weeks after surgery favoring APFX. CONCLUSIONS: Pfilates and Hypopressives are feasible in men undergoing RP, and preliminary data suggest a potential benefit in aiding recovery of urinary control. Larger studies with longer follow-up are warranted. LEVEL OF EVIDENCE: II.

Online interventions for sexual health in cancer.

PURPOSE OF REVIEW: Recent advances in digital healthcare, combined with the increasing appreciation for the need for sexual health programming in cancer, has established a zeitgeist for further development of digital health interventions for sexual health in cancer. Developers of digital health interventions should consider two equally important factors: efficacy of the intervention, and participant engagement. This review describes the status of digital health interventions in sexual health within the oncology setting. RECENT FINDINGS: Sexual dysfunction and related psychological distress affecting patients and their partners is recognized as a significant survivorship care need in the oncology setting. Provision of care is challenged by traditional approaches to disease follow-up, and limited healthcare resources. Digital health interventions may offer efficient, accessible, and scalable care pathways. Digital health innovation in cancer survivorship and sexual health indicates trends toward efficacy, yet patient engagement remains a challenge. Implementation of established online patient engagement approaches are recommended. SUMMARY: Studies to date may underestimate the potential of digital health interventions in sexual health and cancer due to poor patient engagement. Developers of digital health intervention will benefit from effort in employing engagement strategies and engagement-efficacy analysis.

Influence of physical activity on active surveillance discontinuation in men with low-risk prostate cancer.

PURPOSE: Epidemiologic data suggest that high levels of physical activity (PA) may reduce the risk of disease progression in men with prostate cancer (PCa), but it is unknown whether PA can delay the requirement for definitive treatment for those on active surveillance (AS). We investigated the influence of PA post-diagnosis on AS discontinuation in men with low-risk disease. METHODS: The effect of PA on the time to AS discontinuation was assessed in 421 patients, of whom 107 underwent additional PCa treatment over a median of 2.5 years. RESULTS: Using Cox regression models, we found that PA was not significantly associated with time to curative treatment initiation. Prostate-specific antigen (PSA) most proximal to AS initiation (HR, 1.11; 95% CI 1.03 to 1.21) and the number of positive cores (HR, 1.34; 95% CI 1.12 to 1.61) at diagnosis were associated with a significantly increased risk of discontinuing AS. CONCLUSION: Our findings suggest that PA during AS for PCa does not significantly influence time to curative treatment.

Development, implementation, and effects of a cancer center's exercise-oncology program.

BACKGROUND: National and international bodies acknowledge the benefit of exercise for people with cancer, yet limited accessibility to related programing remains. Given their involvement in managing the disease, cancer centers can play a central role in delivering exercise-oncology services. The authors developed and implemented a clinically integrated exercise-oncology program at a major cancer center and evaluated its effectiveness and participant experience. METHODS: A hospital-based program with prescribed at-home exercise was developed and accepted referrals over a 42-month period (3.5 years). Implementation was conducted in 2 phases: a pilot phase for women with breast cancer and men with genitourinary cancer and a roll-out phase for all patients with cancer. Enrolled patients were assessed and received an exercise prescription as well as a program manual, resistance bands, and a stability ball from a kinesiologist. Program participation and effectiveness were evaluated up to 48 weeks after the baseline assessment using intention-to-treat analyses. Participants in the roll-out phase were asked to complete a program experience questionnaire at the completion of the 48-week follow-up. RESULTS: In total, 112 participants enrolled in the pilot, and 150 enrolled in the roll-out phase. Program attrition to 48 weeks was 48% and 65% in the pilot and roll-out phases, respectively. In participants who consented to research evaluation of their performance, objective and patient-reported measures of functional capacity improved significantly from baseline in both phases. Participants were highly satisfied with the program. CONCLUSIONS: Despite significant drop-out to program endpoints, our cancer-exercise program demonstrated clinically relevant improvement in functional outcomes and was highly appreciated by participants.

Prehabilitation and acute postoperative physical activity in patients undergoing radical prostatectomy: a secondary analysis from an RCT.

BACKGROUND: Physical activity via early mobilization after surgery is recommended to help reduce the risk of postoperative adverse effects and to improve recovery. We explored whether prehabilitation is associated with differences in physical activity during the postoperative inpatient stay and the week after discharge in men undergoing abdominal surgery. METHODS: This study was a pre-planned secondary analysis of a larger randomized controlled trial of home-based exercise prehabilitation versus control for men undergoing radical prostatectomy. Twenty-one participants in both the prehabilitation and control groups wore accelerometers from postoperative day 1 until 7 days after discharge. Mean physical activity (minutes) during postoperative day 1 (inpatient) and 1 week following hospital discharge (outpatient) were estimated using ANCOVA. Pearson's correlation coefficients were conducted for mean in- an outpatient physical activity with length of stay and changes in 6-min walk test (6MWT) over the course of the prehabilitation period. RESULTS: Nineteen participants in each group provided usable accelerometry data for analysis. Inpatient physical activity of light or greater activity during postoperative day 1 for prehabilitation and control groups were 442.5 ± 40.2 and 324.0 ± 40.2 min, respectively (∆ = 117.5 ± 57.8 min, 95%CI [0.04, 235.0]). During the outpatient period, mean daily physical activity was 448.4 ± 31.2 and 491.42 ± 31.2 min for prehabilitation and control participants, respectively (∆ = 42.6 ± 44.9 min; 95% CI [- 134.0, 48.7]). There were no correlations between in- or outpatient physical activity and preoperative changes in 6MWT or length of stay. CONCLUSIONS: Accelerometry-based measurement of physical activity in the acute postoperative period is feasible in older men undergoing abdominal surgery. Prehabilitation may be associated with increased inpatient physical activity; however, larger and longer studies are needed to elucidate any associated effects on clinical and patient outcomes. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02036684 registered January 15, 2014.

Prehabilitation for radical prostatectomy: A multicentre randomized controlled trial.

INTRODUCTION: Preoperative exercise and fitness are predictors of surgical recovery; however, little is known of the effect of preoperative exercise-based conditioning, known as prehabilitation, in this for men undergoing radical prostatectomy. Our study examined the feasibility and effects of prehabilitation on perioperative and postoperative outcomes in men undergoing radical prostatectomy. METHODS: This feasibility RCT compared prehabilitation (PREHAB) versus a control condition (CON) in 86 men undergoing radical prostatectomy. PREHAB consisted of home-based, moderate-intensity exercise prior to surgery. Both groups received a preoperative pelvic floor training regimen. Feasibility was assessed via rates of recruitment, attrition, intervention duration and adherence, and adverse events. Clinical outcomes included surgical complications, and length of stay. The following outcomes were assessed at baseline, prior to surgery, and 4, 12, and 26-weeks postoperatively: 6-min walk test (6MWT), upper-extremity strength, quality of life, psychosocial wellbeing, urologic symptoms, and physical activity volume. RESULTS: The recruitment rate was 47% and attrition rates were 25% and 33% for PREHAB and CON, respectively. Adherence to PREHAB was 69% with no serious intervention-related adverse events. After the intervention and prior to surgery, PREHAB participants demonstrated less anxiety (P = 0.035) and decreased body fat percentage (P = 0.001) compared to CON. Four-weeks postoperatively, PREHAB participants had greater 6MWT scores of clinical significance compared to CON (P = 0.006). Finally, compared to CON, grip strength and anxiety were also greater in the PREHAB at 26-weeks (P = 0.022) and (P = 0.025), respectively. CONCLUSION: While feasible and safe, prehabilitation has promising benefits to physical and psychological wellbeing at salient timepoints relative to radical prostatectomy.

Psychological distress and lifestyle disruption in low-risk prostate cancer patients: Comparison between active surveillance and radical prostatectomy.

OBJECTIVE: To quantify distress in men treated with radical prostatectomy (RP) or active surveillance (AS). METHODS: In a retrospective cross-sectional design, we assessed men through questionnaire and investigator-designed questions. RESULTS: RP patients worried more about cancer spread than AS patients. RP patients were influenced by friends for treatment decision, whereas AS patients were influenced by urologists. RP group report declines in intimacy and instrumental. AS men worried more about future health and dying than post-RP men. CONCLUSION: Fear of disease progression may be a motivating factor in choosing RP. AS patients adhere to their treatment decision in spite of distress.

A pilot randomized trial of conventional versus advanced pelvic floor exercises to treat urinary incontinence after radical prostatectomy: a study protocol.

BACKGROUND: Radical prostatectomy is the most common and effective treatment for localized prostate cancer. Unfortunately, radical prostatectomy is associated with urinary incontinence and has a significant negative impact on quality of life. Pelvic floor exercises are the most common non-invasive management strategy for urinary incontinence following radical prostatectomy; however, studies provide inconsistent findings regarding their efficacy. One potential reason for sub-optimal efficacy of these interventions is the under-utilization of regional muscles that normally co-activate with the pelvic floor, such as the transverse abdominis, rectus abdominis, and the diaphragm. Two novel approaches to improve urinary continence recovery are 'Pfilates' and 'Hypopressives' that combine traditional pelvic floor exercises with the activation of additional supportive muscles. Our study will compare an advanced pelvic floor exercise training program that includes Pfilates and Hypopressives, to a conventional pelvic floor exercises regimen for the treatment of post-radical prostatectomy urinary incontinence. METHODS/DESIGN: This is a pilot, randomized controlled trial of advanced pelvic floor muscle training versus conventional pelvic floor exercises for men with localized prostate cancer undergoing radical prostatectomy. Eighty-eight men who will be undergoing radical prostatectomy at hospitals in Toronto, Canada will be recruited. Eligible participants must not have undergone androgen deprivation therapy and/or radiation therapy. Participants will be randomized 1:1 to receive 26 weeks of the advanced or conventional pelvic floor exercise programs. Each program will be progressive and have comparable exercise volume. The primary outcomes are related to feasibility for a large, adequately powered randomized controlled trial to determine efficacy for the treatment of urinary incontinence. Feasibility will be assessed via recruitment success, participant retention, outcome capture, intervention adherence, and prevalence of adverse events. Secondary outcomes of intervention efficacy include measures of pelvic floor strength, urinary incontinence, erectile function, and quality of life. Secondary outcome measures will be collected prior to surgery (baseline), and at 2, 6, 12, 26-weeks post-operatively. DISCUSSION: Pfilates and Hypopressives are novel approaches to optimizing urinary function after radical prostatectomy. This trial will provide the foundation of data for future, large-scale trials to definitively describe the effect of these advanced pelvic floor exercise modalities compared to conventional pelvic floor exercise regimes for men with prostate cancer undergoing radical prostatectomy TRIAL REGISTRATION: Clinicalstrials.gov Identifier: NCT02233608.

Development of a Standardized Set of Patient-centered Outcomes for Advanced Prostate Cancer: An International Effort for a Unified Approach.

BACKGROUND: There are no universally monitored outcomes relevant to men with advanced prostate cancer, making it challenging to compare health outcomes between populations. OBJECTIVE: We sought to develop a standard set of outcomes relevant to men with advanced prostate cancer to follow during routine clinical care. DESIGN, SETTING, AND PARTICIPANTS: The International Consortium for Health Outcomes Measurement assembled a multidisciplinary working group to develop the set. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We used a modified Delphi method to achieve consensus regarding the outcomes, measures, and case mix factors included. RESULTS AND LIMITATIONS: The 25 members of the multidisciplinary international working group represented academic and nonacademic centers, registries, and patients. Recognizing the heterogeneity of men with advanced prostate cancer, the group defined the scope as men with all stages of incurable prostate cancer (metastatic and biochemical recurrence ineligible for further curative therapy). We defined outcomes important to all men, such as overall survival, and measures specific to subgroups, such as time to metastasis. Measures gathered from clinical data include measures of disease control. We also identified patient-reported outcome measures (PROMs), such as degree of urinary, bowel, and erectile dysfunction, mood symptoms, and pain control. CONCLUSIONS: The international multidisciplinary group identified clinical data and PROMs that serve as a basis for international health outcome comparisons and quality-of-care assessments. The set will be revised annually. PATIENT SUMMARY: Our international group has recommended a standardized set of patient-centered outcomes to be followed during routine care for all men with advanced prostate cancer.

Health-related quality of life in robotic versus open radical prostatectomy.

INTRODUCTION: It is unclear whether health-related quality of life (HRQoL) outcomes are superior in robot-assisted radical prostatectomy (RARP) compared to open prostatectomy (ORP). METHODS: We retrospectively analyzed records from men who received ORP or RARP at our institution between January 2009 and December 2012. Patients completed a demographics questionnaire and the Patient-Oriented Prostate Utility Scale (PORPUS), a validated disease-specific HRQoL instrument prior to surgery and every 3 months up to 15 months after surgery. RESULTS: In total, 974 men met the inclusion criteria (643 ORP and 331 RARP patients). At baseline, RARP patients were significantly younger (p < 0.001), had lower body mass index (BMI) (p < 0.001), lower preoperative prostate-specific antigen (PSA) (p < 0.001), fewer comorbidities (p < 0.004), and higher baseline PORPUS scores (p = 0.024). On follow-up, unadjusted PORPUS scores were significantly higher in the RARP group at each point. On multivariable analysis adjusting for age, ORP versus RARP procedure, Gleason score, BMI, first PSA, comorbidity, ethnicity, and baseline PORPUS scores, PORPUS score was higher for the RARP group at 3 months (p = 0.038) and 9 months (p = 0.037), but not at 6, 12, and 15 months (p = 0.014). No difference met pre-defined thresholds of clinical significant. CONCLUSIONS: Though unadjusted HRQoL outcomes appeared improved with RARP compared to ORP differences, adjusted differences were seen at only 2 of 5 postoperative time points, and did not meet pre-defined thresholds of clinical significance. Further randomized trials are needed to assess whether one treatment option provides consistently better HRQoL outcomes.

The acute effects of exercise on cortical excitation and psychosocial outcomes in men treated for prostate cancer: a randomized controlled trial.

PURPOSE: Regular exercise improves psychological well-being in men treated for prostate cancer (PCa). For this population and among cancer survivors in general, the effect of a single bout of exercise on self-report or objective measures of psychological well-being has not been examined. We examined the acute effect of a single bout of exercise on the cortical silent period (CSP) and on self-reported mood in men that have received treatment for PCa. METHODS: Thirty-six PCa survivors were randomly assigned to 60 min of low to moderate intensity exercise or to a control condition. Outcomes were assessed immediately before and after either the exercise or the control condition. RESULTS: No significant between-group differences were observed in CSP or mood were observed following the exercise session or control conditions. Participants with higher scores of trait anxiety had significantly shorter CSP at baseline, as well as those receiving androgen deprivation therapy. Age and baseline CSP had a low-moderate, but significant negative correlation. Changes in CSP following the exercise condition were strongly negatively correlated with changes in self-reported vigor. CONCLUSION: While we did not observe any acute effect of exercise on the CSP in this population, the associations between CSP and trait anxiety, age, and vigor are novel findings requiring further examination. IMPLICATIONS FOR CANCER SURVIVORS: Exercise did not acutely affect our participants in measures of psychological well-being. Additional mechanisms to explain the chronic psychosocial benefits of exercise previously observed in men with PCa require further exploration. Clinicaltrials.gov Identifier: NCT01715064 (http://clinicaltrials.gov/show/NCT01715064).

Prehabilitation for men undergoing radical prostatectomy: a multi-centre, pilot randomized controlled trial.

BACKGROUND: An emerging field of research describes the role of preoperative health behaviours, known as prehabilitation. The preoperative period may be a more physically and emotionally salient time to introduce and foster chronic adherence to health behaviours, such as exercise, in patients compared to post-treatment during recovery. Moreover, physical and psychosocial improvements during the preoperative period may translate into an enhanced recovery trajectory with reduced operative complications and postoperative adverse effects. No studies have assessed prehabilitation for men with prostate cancer undergoing radical prostatectomy. METHODS/DESIGN: This is a multi-centre, pilot randomized control trial conducted at two Canadian urban teaching hospitals. 100 men undergoing radical prostatectomy for prostate cancer with no contraindications to exercise will be recruited and randomized to the prehabiliation program or usual care. Prehabilitation participants will engage in a preoperative, individualized exercise program including pelvic floor muscle strengthening instructions and a healthy lifestyle guide for men with prostate cancer. These participants will be asked to engage in 60 minutes of home-based, unsupervised, moderate-intensity exercise on 3-4 days per week. Usual care participants will receive the same pelvic floor muscle strengthening instructions and healthy lifestyle guide only. We will assess the feasibility of conducting an adequately powered trial of the same design via recruitment rate, programmatic adherence/contamination, attrition, and safety. Estimates of intervention efficacy will be captured through measurements at baseline (4-8 weeks preoperatively), within 1 week prior to surgery, and postoperatively at 4, 12, and 26 weeks. Efficacy outcomes include: fatigue, quality of life, urinary incontinence, physical fitness, body composition, aerobic fitness, pain, and physical activity volume. DISCUSSION: The primary outcome of this study is to determine the feasibility of conducting a full-scale, randomized controlled trial of prehabilitation versus usual care and to estimate effect sizes that will inform sample size determinations for subsequent trials in this field. To our knowledge, this is the first study to examine a structured presurgical exercise program for men undergoing radical prostatectomy for prostate cancer. This trial will advance our understanding of strategies to efficiently and effectively use the preoperative period to optimize postoperative recovery. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02036684.