PC-PEP, a Comprehensive Daily Six-Month Home-Based Patient Empowerment Program Leads to Weight Loss in Men with Prostate Cancer: A Secondary Analysis of a Clinical Trial.

Background: The Prostate Cancer-Patient Empowerment Program (PC-PEP) is a six-month daily home-based program shown to improve mental health and urinary function. This secondary analysis explores weight loss in male PC-PEP participants. Methods: In a randomized clinical trial with 128 men undergoing curative prostate cancer (PC) treatment, 66 received 'early' PC-PEP, while 62 were assigned to the 'late' waitlist-control group, receiving 6 months of standard-of-care treatment followed by 6 months of PC-PEP. PC-PEP comprised 182 daily emails with video-based exercise and dietary (predominantly plant-based) education, live online events, and 30 min strength training routines (using body weight and elastic bands). Weight and height data were collected via online surveys (baseline, 6 months, and 12 months) including medical chart reviews. Adherence was tracked weekly. Results: No attrition or adverse events were reported. At 6 months, the early PC-PEP group experienced significant weight loss, averaging 2.7 kg (p < 0.001) compared to the waitlist-control group. Weight loss was noted in the late intervention group of PC-PEP, albeit less pronounced than in the early group. Early PC-PEP surgery patients lost on average 1.4 kg (SE = 0.65) from the trial's start to surgery day. High adherence to exercise and dietary recommendations was noted. Conclusions: PC-PEP led to significant weight loss in men undergoing curative prostate cancer treatment compared to standard-of-care.

Six-Month Prostate Cancer Empowerment Program (PC-PEP) Improves Urinary Function: A Randomized Trial.

Purpose: This is a secondary analysis examining a six-month home-based Prostate Cancer-Patient Empowerment Program (PC-PEP) on patient-reported urinary, bowel, sexual, and hormonal function in men with curative prostate cancer (PC) against standard of care. Methods: In a crossover clinical trial, 128 men scheduled for PC surgery (n = 62) or radiotherapy with/without hormones (n = 66) were randomized to PC-PEP (n = 66) or waitlist-control and received the standard of care for 6 months, and then PC-PEP to the end of the year. PC-PEP included daily emails with video instructions, aerobic and strength training, dietary guidance, stress management, and social support, with an initial PFMT nurse consultation. Over 6 months, participants in the PC-PEP received optional text alerts (up to three times daily) reminding them to follow the PFMT video program, encompassing relaxation, quick-twitch, and endurance exercises; compliance was assessed weekly. Participants completed baseline, 6, and 12-month International Prostate Symptom Score (IPSS) and Expanded Prostate Cancer Index Composite (EPIC) questionnaires. Results: At 6 months, men in the PC-PEP reported improved urinary bother (IPSS, p = 0.004), continence (EPIC, p < 0.001), and irritation/obstruction function (p = 0.008) compared to controls, with sustained urinary continence benefits at 12 months (p = 0.002). Surgery patients in the waitlist-control group had 3.5 (95% CI: 1.2, 10, p = 0.024) times and 2.3 (95% CI: 0.82, 6.7, p = 0.11) times higher odds of moderate to severe urinary problems compared to PC-PEP at 6 and 12 months, respectively. Conclusions: PC-PEP significantly improves lower urinary tract symptoms, affirming its suitability for clinical integration alongside established mental health benefits in men with curative prostate cancer.

Changes in Stress Reduction Following a 28-Day Prostate Cancer Patient Empowerment Program (PC-PEP) among Prostate Cancer Survivors.

Prostate cancer (PCa) survivors often experience post-treatment challenges that impact their well-being and mental health. The Prostate Cancer Patient Empowerment Program (PC-PEP) aims to address these issues through a comprehensive intervention, involving daily meditation/breathing exercises, physical activity, pelvic floor exercises, emotional connection strategies, and peer support. This study presents a secondary analysis of a Phase 2 feasibility study that evaluated the effects of a 28-day PC-PEP intervention on stress reduction. Thirty patients with PCa from the Maritimes, Canada, underwent pre- and post-intervention assessments to measure brainwave activity (delta, theta, alpha, beta, and gamma) using the Muse™ headband, and heart rate variability (HRV) using the HeartMath® Inner Balance™ as indicators of stress reduction. A statistically significant Time × Sensor Scalp Assessment Time interaction emerged for all brain waves. Amplitudes were generally higher during the first half of the meditation assessment time but became comparable afterward. A statistically significant Time × Sensor Scalp Location × Sensor Scalp Assessment Time interaction also emerged for alpha waves, indicating higher prefrontal lobe amplitudes than temporal lobe amplitudes from pre- to post-assessment. There were no statistically significant differences in HRV metrics from pre- to post-intervention, except for a marginally significant achievement score, indicating increased HRV coherence post-intervention. The findings suggest that the stress reduction component of PC-PEP successfully improved outcomes related to decreased stress. These results have implications for the development of future iterations of PC-PEP interventions, aiming to optimize participant benefits.

Assessing the Efficacy of a 28-Day Comprehensive Online Prostate Cancer Patient Empowerment Program (PC-PEP) in Facilitating Engagement of Prostate Cancer Patients in Their Survivorship Care: A Qualitative Study.

A 28-day Prostate Cancer-Patient Empowerment Program (PC-PEP) developed through patient engagement was successful at promoting mental and physical health. Thirty prostate cancer patients from Halifax, Canada participated in the 28-day PC-PEP intervention in early 2019. PC-PEP encompassed daily patient education and empowerment videos, prescribed physical activities (including pelvic floor exercises), a mostly plant-based diet, stress reduction techniques, intimacy education, social connection, and support. Quantitative exit surveys and semi-structured interviews (conducted in focus groups of ten) were used to assess perceived factors that facilitated or impeded adherence to the program. The program received high praise from the patients and was deemed extremely useful by the participating men, who rated it 9 out of 10. Patients expressed that the multifaceted, online, home-based nature of the program helped them adhere to it better than they would have had to a single or less comprehensive intervention. Feedback from the participants indicated that the program, when viewed as a whole, was perceived as greater than the sum of its individual parts. Furthermore, the program addressed various issues, including emotional vulnerability and distress, physical fitness, urinary incontinence, challenges in expressing emotions, perceived lack of control over healthcare decisions, emotional fragility, and hesitancy to discuss prostate cancer-related matters in social settings. Patients highly (9.6/10) endorsed integrating the program into the standard care regimen from the very beginning of diagnosis. However, challenges such as work commitments were noted. Patients' high endorsement of PC-PEP suggests that its implementation into the standard of care from day one of diagnosis may be warranted.

A Comprehensive 6-mo Prostate Cancer Patient Empowerment Program Decreases Psychological Distress Among Men Undergoing Curative Prostate Cancer Treatment: A Randomized Clinical Trial.

BACKGROUND: Although survival rates for newly diagnosed prostate cancer patients are very high, most of them will likely suffer significant treatment-related side effects, depression, or anxiety, affecting their quality of life. OBJECTIVE: The aim of this study was to examine the effects of a 6-mo online home-based physical, mental, and social support intervention, the Prostate Cancer Patient Empowerment Program (PC-PEP), on preventing psychological distress among men undergoing curative prostate cancer treatment. DESIGN, SETTING, AND PARTICIPANTS: In a crossover randomized clinical trial of 128 men aged 50-82 yr scheduled for curative prostate cancer surgery or radiotherapy (± hormone treatment), 66 received the 6-mo PC-PEP intervention and 62 were randomized to a waitlist-control arm and received the standard of care for 6 mo, and then PC-PEP to the end of the year. The PC-PEP intervention consisted of daily e-mails with video instructions providing education, patient activation, and empowerment on healthy living including physical and mental health, dietary recommendations, social support, physical and pelvic floor fitness, stress reduction using a biofeedback device, social connection and intimacy, and social support. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was nonspecific psychological distress (clinical cutoff ≥20) measured at baseline, and at 6 and 12 mo using the Kessler Psychological Distress Scale (K10). RESULTS AND LIMITATIONS: At 6 mo, patients in the waitlist-control group had 3.59 (95% confidence interval: 1.12-11.51) times higher odds for nonspecific psychological distress and need for psychological treatment than men who received the PC-PEP intervention. At 12 mo, the wait-list control group that received the intervention at 6 mo had higher psychological distress than the early group. CONCLUSIONS: PC-PEP delivered early following diagnosis significantly prevented the burden of psychological distress in men undergoing curative prostate cancer treatment compared with standard of care, or late (6 mo later) intervention. PATIENT SUMMARY: In this report, we looked at the effectiveness of a program (Prostate Cancer Patient Empowerment Program: PC-PEP) developed with patients' engagement on the mental distress of patients awaiting curative treatment for their prostate cancer. The PC-PEP program lasted for 6 mo, and it prescribed, described, and demonstrated daily aerobic and strength training, kegels (pelvic floor training to help with urinary and sexual function), dietary changes that have been shown to be helpful in the prevention of prostate cancer and prostate cancer progression, stress reduction using a biofeedback device, as well as social and emotional support. All patients in the PC-PEP program were invited to a monthly video conference with the leads of the program who appeared in the 6 mo of daily videos prescribing the activities the patients were asked to watch and follow. The leads were a prostate cancer oncologist and a scientist in prostate cancer quality of life research. Half of the patients in this study received PC-PEP daily for the first 6 mo and were re-assessed at the end of the year. The other half received standard of care for 6 month and then received the intervention to the end of the year. The results of the study show that, at 6 mo, this intervention was effective at reducing the mental distress that accompanies a prostate cancer diagnosis and treatment compared with the standard of care. Mental distress was significantly reduced when the intervention was received early, compared with that received late (6 mo after scheduled curative treatment). We conclude that multi-faceted patient education and empowerment programming of this kind that is developed with patient engagement from the start is crucial to the care of patients diagnosed with prostate cancer and should be implemented in the standard of care. While treatment for prostate cancer is highly successful, side effects that accompany most treatments significantly affect the quality of life of patients. Here, we describe PC-PEP, a patient education and activation program that is cost effective, highly enforced by patients, and successful at reducing the impact of prostate cancer active treatment-related side effects on their psychological state. To learn more about this project, please visit www.pcpep.org. The program is now being tested in a phase 4 implementation trial throughout Canada and internationally (New Zealand), and is being expanded and tested for other types of cancer.

Treatment Regret, Mental and Physical Health Indicators of Psychosocial Well-Being among Prostate Cancer Survivors.

Prostate cancer (PCa) patients and survivors are at high risk of mental health illness. Here, we examined the contribution of treatment regret, mental and physical health indicators to the social/family, emotional, functional and spiritual well-being of PCa survivors. The study assessed 367 men with a history of PCa residing in the Maritimes Canada who were surveyed between 2017 and 2021. The outcomes were social/family, emotional, functional and spiritual well-being (FACT-P,FACIT-Sp). Predictor variables included urinary, bowel and sexual function (UCLA-PCI), physical and mental health (SF-12), and treatment regret. Logistic regression analyses were controlled for age, income, and survivorship time. Poor social/family, emotional, functional and spiritual well-being was identified among 54.4%, 26.5%, 49.9% and 63.8% of the men in the sample. Men who reported treatment regret had 3.62, 5.58, or 4.63 higher odds of poor social/family, emotional, and functional well-being, respectively. Men with low household income had 3.77 times higher odds for poor social/well-being. Good mental health was a protective factor for poor social/family, emotional, functional, or spiritual well-being. Better physical and sexual health were protective factors for poor functional well-being. Seeking to promote PCa patients' autonomy in treatment decisions and recognizing this process' vulnerability in health care contexts is warranted.

Psychosocial and Functional Predictors of Mental Disorder among Prostate Cancer Survivors: Informing Survivorship Care Programs with Evidence-Based Knowledge.

Recent research has revealed that prostate cancer (PCa) survivors are facing a silent epidemic of mental disorder. These findings are not surprising when the side effects of highly effective current treatment modalities are considered. Here, we assess the association between urinary function and quality of life indicators to mental disorder among survivors of PCa. This is a cross sectional examination of an analytical sample of 362 men with a history of PCa residing in the Maritimes who took a survey assessing social, physical and health-related quality of life indicators between 2017 and 2021. Mental disorder was assessed using Kessler's Psychological Distress Scale (K-10). Predictor variables included emotional, functional, social/family and spiritual well-being, measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P), and urinary function was measured by International Prostate Symptom Score (IPSS). Multivariate logistic regression analysis evaluated the contribution of predictors while controlling for age, income, survivorship time (months) since diagnosis, relationship status and treatment modality. Mental disorder was identified among 15.8% of PCa survivors in this sample. High emotional (aOR = 0.81, 95% CI: 0.69-0.96) and spiritual well-being (aOR = 0.88, 95% CI: 0.81-0.96) were protective factors against mental disorder. Men who screened positive for moderate to severe urinary tract symptoms had three times higher odds (aOR = 3.02, 95% CI: 1.10, 8.32) of screening positive for mental disorder. Men who were on active surveillance or radical prostatectomy with or without added treatment had higher (aOR = 5.87, 95% CI: 1.32-26.13 or aOR = 4.21, 95% CI: 1.07-16.51, respectively) odds of screening positive for mental disorder compared to men who received radiation treatment with or without hormonal therapy for their PCa diagnosis. Unmet emotional and spiritual needs, increased urinary problems and some forms of treatment (e.g., active surveillance or surgery) were associated with mental disorder among PCa survivors. The development of survivorship care programs and support systems that focus on the long-term effects of PCa treatments and the consequences of unmet psychosocial needs of patients during the survivorship journey are critically needed.

Current Mental Distress Among Men With a History of Radical Prostatectomy and Related Adverse Correlates.

Recent reviews and observational studies have reported that patients with prostate cancer (PCa) are at increased risk of mental health issues, which in turn negatively affects oncological outcomes. Here, we examine possible explanatory variables of mental distress in a population-based cohort of men who have undergone radical prostatectomy (RP). Data were derived from a Maritimes-Canada online survey assessing patient-reported quality of life outcomes between 2017 and 2019 administered to 136 men (47-88 years old, currently in a relationship) who have undergone RP for their PCa diagnosis. The primary outcome was a validated assessment of mental distress, the Kessler Psychological Distress Scale (K10). Urinary function was assessed using the International Prostate Symptom Score, and relationship satisfaction was assessed using the Dyadic Assessment Scale. A multivariate logistic regression assessed the contribution of urinary function, relationship satisfaction, age, multimorbidity, additional treatments, medication for depression and/or anxiety, and survivorship time. A total of 16.2% men in this sample screened positive for mental distress. The severity of urinary problems was positively associated with increased mental distress (OR = 4.79, 95% CI [1.04, 22.03]), while increased age (OR = 0.87, 95% CI [0.78, 0.97]), relationship satisfaction (OR = 0.14, 95% CI [0.3, .077]), and current medication for anxiety, depression, or both (OR = 0.09, 95% CI [0.02, 0.62]) were protective factors. Survivorship time, the presence of additional comorbidities, or PCa treatments were not identified to be statistically significant contributions to the fitted model. Here, we report that RP survivors are prone to presenting with increased mental distress long after treatment. Screening for mental distress during RP survivorship is recommended.

An Examination of the Relationship between Mental Distress, Functional and Psychosocial Quality of Life Indicators in a Population Based Sample of Prostate Cancer Survivors Who Received Curative Treatment.

INTRODUCTION: Although survival rates are highest among prostate cancer survivors compared to any other forms of cancer, nearly 60% suffer from mental distress. Here we examine urinary function and psychosocial stressors and their association with poor mental health in a younger group of prostate cancer survivors who have undergone curative treatment. METHODS: The study includes 128 men (47 to 70 years old) who received active treatment for prostate cancer, and completed a survivorship online survey between 2017 and 2018. Psychological distress was assessed with Kessler Psychological Distress Scale. International Prostate Symptom Score subscales (incomplete urinary emptying, frequency, intermittency, urgency, weak stream, straining and nocturia) and number of current prostate cancer survivorship stressors were predictors. Multivariate logistic regression was used to fit the model while controlling for months of survivorship since diagnosis, the presence or absence of surgery, radiation or hormone therapy treatment, current medication for depression and demographics. RESULTS: A total of 19.5% of men scored positive for current mental health issues. Prostate cancer survivors who reported increased number of current survivorship stressors (OR 1.48, 95% CI 1.09-2.01), had higher frequency of urination (OR 2.05, 95% CI 1.15-3.64), history of radiation treatment (OR 7.15, 95% CI 1.02-50.35) and were currently on prescribed medication for depression (OR 33.47, 95% CI 3.80-294.87) had higher odds for screening positive for psychological distress compared with their counterparts. CONCLUSIONS: These results corroborate recent findings showing an intersection between urological oncology and poor mental health during survivorship, and warrant the development of multidisciplinary teams in addressing survivorship issues in this population.