scholarly journals Community pharmacy lifestyle intervention to increase physical activity and improve cardiovascular health of men with prostate cancer: a phase II feasibility study

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e025114 ◽  
Author(s):  
Agnieszka Lemanska ◽  
Karen Poole ◽  
Bruce A Griffin ◽  
Ralph Manders ◽  
John M Saxton ◽  
...  
Keyword(s):  
Physical Activity ◽  
Prostate Cancer ◽  
Community Pharmacy ◽  
Lifestyle Intervention ◽  
Feasibility Study ◽  
Phase Ii ◽  
Cardiovascular Health ◽  
Health Assessment ◽  
Phone Calls ◽  
Patient Reported

ObjectivesTo assess the feasibility and acceptability of a community pharmacy lifestyle intervention to improve physical activity and cardiovascular health of men with prostate cancer. To refine the intervention.DesignPhase II feasibility study of a complex intervention.SettingNine community pharmacies in the UK.InterventionCommunity pharmacy teams were trained to deliver a health assessment including fitness, strength and anthropometric measures. A computer algorithm generated a personalised lifestyle prescription for a home-based programme accompanied by supporting resources. The health assessment was repeated 12 weeks later and support phone calls were provided at weeks 1 and 6.Participants116 men who completed treatment for prostate cancer.Outcome measuresThe feasibility and acceptability of the intervention and the delivery model were assessed by evaluating study processes (rate of participant recruitment, consent, retention and adverse events), by analysing delivery data and semi-structured interviews with participants and by focus groups with pharmacy teams. Physical activity (measured with accelerometry at baseline, 3 and 6 months) and patient reported outcomes (activation, dietary intake and quality of life) were evaluated. Change in physical activity was used to inform the sample size calculations for a future trial.ResultsOut of 403 invited men, 172 (43%) responded and 116 (29%) participated. Of these, 99 (85%) completed the intervention and 88 (76%) completed the 6-month follow-up (attrition 24%). Certain components of the intervention were feasible and acceptable (eg, community pharmacy delivery), while others were more challenging (eg, fitness assessment) and will be refined for future studies. By 3 months, moderate to vigorous physical activity increased on average by 34 min (95% CI 6 to 62, p=0.018), but this was not sustained over 6 months.ConclusionsThe community pharmacy intervention was feasible and acceptable. Results are encouraging and warrant a definitive trial to assess the effectiveness of the refined intervention.

scholarly journals Patient activation and patient-reported outcomes of men from a community pharmacy lifestyle intervention after prostate cancer treatment

2021 ◽  
Author(s):  
Agnieszka Lemanska ◽  
Karen Poole ◽  
Ralph Manders ◽  
John Marshall ◽  
Zachariah Nazar ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Treatment ◽  
Community Pharmacy ◽  
Lifestyle Intervention ◽  
Patient Reported Outcomes ◽  
Age Groups ◽  
Patient Activation ◽  
Prostate Cancer Treatment ◽  
Patient Reported ◽  
The Uk

Abstract Purpose To report patient activation, which is the knowledge, skills, and confidence in self-managing health conditions, and patient-reported outcomes of men after prostate cancer treatment from a community pharmacy lifestyle intervention. Methods The 3-month lifestyle intervention was delivered to 116 men in nine community pharmacies in the UK. Patient Activation Measure (PAM) was assessed at baseline, 3 and 6 months. Prostate cancer-related function and quality of life were assessed using the European Prostate Cancer Index Composite (EPIC-26) and EuroQOL 5-dimension 5-level (EQ5D-5L) questionnaires at baseline and 6 months. Lifestyle assessments included Mediterranean Diet Adherence Screener (MEDAS) at baseline, 3 and 6 months and Godin Leisure Time Exercise Questionnaire (GLTEQ) at baseline and 3 months. Results PAM score increased from 62 [95% CI 59–65] at baseline to 66 [64–69] after the intervention (p = 0.001) and remained higher at 6 months (p = 0.008). Scores for all the EPIC-26 domains (urinary, bowel and hormonal) were high at both assessments, indicating good function (between 74 [70–78] and 89 [86–91]), except sexual domain, where scores were much lower (21 [17–25] at baseline, increasing to 24 [20–28] at 6 months (p = 0.012)). In EQ5D-5L, 3% of men [1–9] reported self-care problems, while 50% [41–60] reported pain and discomfort, and no significant changes over time. Men who received androgen deprivation therapy, compared with those who did not, reported higher (better) urinary incontinence scores (p < 0.001), but lower (worse) scores in the urinary irritative/obstructive (p = 0.003), bowel (p < 0.001) and hormonal (p < 0.001) domains. Poor sexual function was common across all age groups irrespective of prostate cancer treatment. Conclusions The intervention led to significant improvements in patient activation, exercise and diet. Community pharmacy could deliver effective services to address sexual dysfunction, pain and discomfort which are common after prostate cancer.

scholarly journals Phase II study of stereotactic body radiotherapy with hydrogel spacer for prostate cancer: acute toxicity and propensity score-matched comparison

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Mami Ogita ◽  
Hideomi Yamashita ◽  
Yuki Nozawa ◽  
Sho Ozaki ◽  
Subaru Sawayanagi ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Propensity Score ◽  
Acute Toxicity ◽  
Phase Ii ◽  
Stereotactic Body Radiotherapy ◽  
Phase Ii Study ◽  
Summary Score ◽  
Trial Registration ◽  
Gu Toxicity ◽  
Patient Reported

Abstract Background The efficacy of a hydrogel spacer in stereotactic body radiotherapy (SBRT) has not been clarified. We evaluated the safety and efficacy of SBRT in combination with a hydrogel spacer for prostate cancer. Methods This is a prospective single-center, single-arm phase II study. Prostate cancer patients without lymph node or distant metastasis were eligible. All patients received a hydrogel spacer insertion, followed by SBRT of 36.25 Gy in 5 fractions with volumetric modulated arc therapy. The primary endpoint was physician-assessed acute gastrointestinal (GI) toxicity within 3 months. The secondary endpoints were physician-assessed acute genitourinary (GU) toxicity, patient-reported outcomes evaluated by the EPIC and FACT-P questionnaires, and dosimetric comparison. We used propensity score-matched analyses to compare patients with the hydrogel spacer with those without the spacer. The historical data of the control without a hydrogel spacer was obtained from our hospital’s electronic records. Results Forty patients were enrolled between February 2017 and July 2018. A hydrogel spacer significantly reduced the dose to the rectum. Grade 2 acute GI and GU toxicity occurred in seven (18%) and 17 (44%) patients. The EPIC bowel and urinary summary score declined from the baseline to the first month (P < 0.01, < 0.01), yet it was still significantly lower in the third month (P < 0.01, P = 0.04). For propensity score-matched analyses, no significant differences in acute GI and GU toxicity were observed between the two groups. The EPIC bowel summary score was significantly better in the spacer group at 1 month (82.2 in the spacer group and 68.5 in the control group). Conclusions SBRT with a hydrogel spacer had the dosimetric benefits of reducing the rectal doses. The use of the hydrogel spacer did not reduce physician-assessed acute toxicity, but it improved patient-reported acute bowel toxicity. Trial registration: Trial registration: UMIN-CTR, UMIN000026213. Registered 19 February 2017, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029385.

Comparing the Measurement Properties and Preferability of Patient Reported Outcome Measures in Pediatric Rheumatology: PROMIS versus CHAQ

2020 ◽  
pp. jrheum.200943
Author(s):  
Joshua Craig ◽  
Brian M. Feldman ◽  
Lynn Spiegel ◽  
Saunya Dover
Keyword(s):  
Physical Activity ◽  
Disease Activity ◽  
Pediatric Rheumatology ◽  
Health Assessment ◽  
Patient Reported Outcome Measures ◽  
Pain Interference ◽  
Measurement Properties ◽  
Measurement Information ◽  
Patient Reported ◽  
Ceiling Effects

Objective The Childhood Health Assessment Questionnaire (CHAQ), though widely used for assessments in pediatric rheumatology, has drawbacks, including low correlation to disease activity and ceiling effects. We sought to determine if any tools from the Patient Reported Outcomes Measurement Information System (PROMIS) improve on these shortcomings and/or are preferred by patients. Methods Patients 5-17 years of age, with childhood arthritis (JIA) or juvenile dermatomyositis (JDM) were recruited from the rheumatology clinics at a Canadian children’s hospital. Participants completed the CHAQ, 3 PROMIS measures (pain interference, mobility, and physical activity), and underwent a standard clinical assessment. Results 52 patients participated, 25 with JIA and 27 with JDM. None of the PROMIS measures suffered from ceiling effects, while the CHAQ disability index (DI) and pain visual analog scales both did, with 50% and 20% of patients achieving the best possible scores respectively. The PROMIS mobility was moderately correlated CHAQ DI (rs = -0.60, 95%CI = -0.75--0.40) and the PROMIS pain interference was strongly correlated to the CHAQ pain score (rs = 0.65, 95%CI = 0.43-0.80). No measures correlated with disease activity. Patients preferred the PROMIS to the CHAQ. Conclusion The PROMIS pain interference, mobility and physical activity measures improve in some areas where the CHAQ is weak: they do not suffer from ceiling effects and patients prefer the PROMIS tools. More work is needed to determine the correlation and responsiveness of the PROMIS tools to changes in disease activity over time before they should be widely adopted for clinical use.

scholarly journals NeuroSAFE robot-assisted laparoscopic prostatectomy versus standard robot-assisted laparoscopic prostatectomy for men with localised prostate cancer (NeuroSAFE PROOF): protocol for a randomised controlled feasibility study

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e028132 ◽  
Author(s):  
Eoin Dinneen ◽  
Aiman Haider ◽  
Clare Allen ◽  
Alex Freeman ◽  
Tim Briggs ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Feasibility Study ◽  
Functional Outcomes ◽  
Surgical Margin ◽  
Urinary Continence ◽  
Positive Surgical Margin ◽  
Robot Assisted ◽  
Laparoscopic Prostatectomy ◽  
Patient Reported ◽  
Randomised Controlled

IntroductionRobot-assisted laparoscopic prostatectomy (RALP) offers potential cure for localised prostate cancer but is associated with considerable toxicity. Potency and urinary continence are improved when the neurovascular bundles (NVBs) are spared during a nerve spare (NS) RALP. There is reluctance, however, to perform NS RALP when there are concerns that the cancer extends beyond the capsule of the prostate into the NVB, as NS RALP in this instance increases the risk of a positive surgical margin (PSM). The NeuroSAFE technique involves intraoperative fresh-frozen section analysis of the posterolateral aspect of the prostate margin to assess whether cancer extends beyond the capsule. There is evidence from large observational studies that functional outcomes can be improved and PSM rates reduced when the NeuroSAFE technique is used during RALP. To date, however, there has been no randomised controlled trial (RCT) to substantiate this finding. The NeuroSAFE PROOF feasibility study is designed to assess whether it is feasible to randomise men to NeuroSAFE RALP versus a control arm of ‘standard of practice’ RALP.MethodsNeuroSAFE PROOF feasibility study will be a multicentre, single-blinded RCT with patients randomised 1:1 to either NeuroSAFE RALP (intervention) or standard RALP (control). Treatment allocation will occur after trial entry and consent. The primary outcome will be assessed as the successful accrual of 50 men at three sites over 15 months. Secondary outcomes will be used to aid subsequent power calculations for the definitive full-scale RCT and will include rates of NS; PSM; biochemical recurrence; adjuvant treatments; and patient-reported functional outcomes on potency, continence and quality of life.Ethics and disseminationNeuroSAFE PROOF has ethical approval (Regional Ethics Committee reference 17/LO/1978). NeuroSAFE PROOF is supported by National Institute for Healthcare Research Research for Patient Benefit funding (NIHR reference PB-PG-1216-20013). Findings will be made available through peer-reviewed publications.Trial registration numberNCT03317990.

Prostate 8 study: A pilot randomized controlled trial (RCT) of a web-based lifestyle intervention versus control group among men with prostate cancer.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 105-105
Author(s):  
Stacey A. Kenfield ◽  
Erin Van Blarigan ◽  
Niloufar Ameli ◽  
Emil Lavaki ◽  
Cynthia Monroy ◽  
...  
Keyword(s):  
Physical Activity ◽  
Prostate Cancer ◽  
Lifestyle Intervention ◽  
Cancer Progression ◽  
Text Messaging ◽  
Control Group ◽  
Processed Meat ◽  
Accelerometer Data ◽  
Vigorous Activity ◽  
Lifestyle Behaviors

105 Background: Lifestyle behaviors may reduce risk of prostate cancer progression. Guidelines and tools to support lifestyle modification are needed to improve prostate cancer care. Methods: We conducted a 12-week RCT among 73 men with clinical stage T1-T3a prostate cancer to determine if a lifestyle intervention that included a responsive website, Fitbits, and text messaging helps men adopt 8 healthy lifestyle behaviors (vigorous activity, not smoking, and 6 diet factors) compared to a control group. Eligible men had no contra-indications to aerobic exercise, Internet access, and engaged in ≤4 of the targeted 8 habits at baseline. We explored the efficacy of the intervention (n = 32) vs. control (n = 32) on behavior change via a lifestyle survey, 7 days of ActiGraph GT3X+ accelerometer data, and the Prostate 8 (P8) score (8 self-reported behaviors assigned 0 or 1 point, range 0-8). Results: Baseline characteristics were similar between arms. The median baseline P8 score was 3 in each arm. 12-week assessments were 88% complete (intervention, 94%; control, 82%). Intervention arm participants’ wore their Fitbits a median of 82 days (98%, IQR: 72-83), replied to a median of 71% of texts (N = 60, IQR: 57-89%), and visited the website a median of 3 days [IQR: 2-5] and over 3 visits [IQR: 2-5]. Baseline moderate and vigorous activity were self-reported as 3.7 hrs/wk and 12 min/wk (intervention) and 5.3 hrs/wk and 18 min/wk (control). 1 person was a smoker at baseline. Median [IQR] absolute change in the P8 score from baseline to 12 wks was 2.0 [1.0, 3.0] (intervention) and 0.0 [-1.0, 1.0] (control) (p = 0.0005); and the change between groups was statistically significant for cooked tomatoes, cruciferous vegetables, fish, processed meat, but not significant for healthy sources of vegetable fat (high at baseline) or vigorous activity. Accelerometer data indicated no significant differences in change in physical activity between arms. Conclusions: This novel intervention was feasible and acceptable. These data suggest that the intervention was effective for promoting healthier dietary changes; further research is warranted to examine how to facilitate improvements in physical activity. Clinical trial information: NCT02470936.

scholarly journals A Lifestyle Intervention via Email in Minority Breast Cancer Survivors: Randomized Parallel-Group Feasibility Study (Preprint)

2017 ◽  
Author(s):  
Raheem J Paxton ◽  
Richard Hajek ◽  
Patricia Newcomb ◽  
Megha Dobhal ◽  
Sujana Borra ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Physical Activity ◽  
Cancer Survivors ◽  
Ethnic Minority ◽  
Lifestyle Intervention ◽  
Breast Cancer Survivors ◽  
Web Based ◽  
Phone Calls ◽  
Racial And Ethnic Minority ◽  
The Web

BACKGROUND Our data have indicated that minority breast cancer survivors are receptive to participating in lifestyle interventions delivered via email or the Web, yet few Web-based studies exist in this population. OBJECTIVE The aim of this study was to examine the feasibility and preliminary results of an email-delivered diet and activity intervention program, “A Lifestyle Intervention Via Email (ALIVE),” delivered to a sample of racial and ethnic minority breast cancer survivors. METHODS Survivors (mean age: 52 years, 83% [59/71] African American) were recruited and randomized to receive either the ALIVE program’s 3-month physical activity track or its 3-month dietary track. The fully automated system provided tools for self-monitoring and goal setting, tailored content, and automated phone calls. Descriptive statistics and mixed-effects models were computed to examine the outcomes of the study. RESULTS Upon completion, 44 of 71 survivors completed the study. Our “intention-to-treat” analysis revealed that participants in the physical activity track made greater improvements in moderate to vigorous activity than those in the dietary track (+97 vs. +49 min/week, P<.001). Similarly, reductions in total sedentary time among those in the physical activity track (−304 vs. −59 min/week, P<.001) was nearly 5 times greater than that for participants in the dietary track. Our completers case analysis indicated that participants in the dietary track made improvements in the intake of fiber (+4.4 g/day), fruits and vegetables (+1.0 cup equivalents/day), and reductions in saturated fat (−2.3 g/day) and trans fat (−0.3 g/day) (all P<.05). However, these improvements in dietary intake were not significantly different from the changes observed by participants in the physical activity track (all P>.05). Process evaluation data indicated that most survivors would recommend ALIVE to other cancer survivors (97%), were satisfied with ALIVE (82%), and felt that ALIVE was effective (73%). However, survivors expressed concerns about the functionality of the interactive emails. CONCLUSIONS ALIVE appears to be feasible for racial and ethnic minority cancer survivors and showed promising results for larger implementation. Although survivors favored the educational content, a mobile phone app and interactive emails that work on multiple email domains may help to boost adherence rates and to improve satisfaction with the Web-based platform. CLINICALTRIAL ClinicalTrials.gov NCT02722850; https://clinicaltrials.gov/ct2/show/NCT02722850 (Archived by WebCite at http://www.webcitation.org/6tHN9VsPh)

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