This study was a two-armed, parallel-group randomised controlled trial. Participants were from one radiotherapy unit, serving four hospitals within NHS England, UK. They had received external beam radiotherapy (EBRT) with neo-adjuvant or adjuvant androgen deprivation therapy (ADT) or low dose-rate brachytherapy (BT).
Setting and participants
Men starting EBRT were asked to participate in the trial during on-treatment physician review. BT patients were invited by letter from their clinical nurse specialist (CNS) after treatment. All participant consent forms were returned by post. To allow for recovery of acute symptoms after treatment, men were screened for urinary symptoms at 3 months after EBRT with the International Prostate Symptom Score (IPSS) questionnaire and 6 months after BT. Men with IPSS scores ≥ 8 (moderate to severe symptoms) i.e., 70 of the 137 men, were entered into the trial and after baseline assessment they were randomised to receive either the SMaRT intervention plus care-as-usual, or only care-as-usual. Care-as-usual was defined as hospital appointments for surveillance and symptom management with the clinical oncologist and/or telephone support with the CNS. Eligibility criteria are summarised in Table 1. Men were stratified for type of radiotherapy treatment (EBRT vs BT) and randomisation was provided by a registered clinical trials unit. To ensure balance in group sizes, participants were randomly allocated to control or intervention in blocks of 12. Information about treatment, medication, TNM staging, and comorbidity was obtained from the medical records.
Table 1
SMaRT study eligibility criteria
Inclusion
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Patients who had:
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• Locally confined prostate cancer disease (up to stage T3BNO)
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• Received neoadjuvant hormonal therapy (to control for standardised practice as recommended in the EAU Guidelines).
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• Completed external beam radiotherapy three to four months prior to the intended commencement of the intervention.
• Or LDR brachytherapy six months prior to the intended commencement of the intervention.
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• Moderate to severe urinary symptoms defined as a score of ≥ 8 on the International Prostate Symptom Score (IPSS).
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• Sufficient understanding of written and spoken English.
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Exclusion
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Patients who had:
• A urinary tract infection.
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• A current psychiatric referral.
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• A current referral for memory issues/ever been referred to a memory clinic/taking prescribed medication to help with memory.
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• Required an interpreter.
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Intervention
The SMaRT intervention was based on the framework that to be effective, self-management must address three core tasks namely, medical management (taking medications and treatment exercises), role management (adapting lifestyle or life roles) and emotional management (26). Having the confidence or belief to perform a given course of action is also a key mechanism whereby self-management can lead to changes in health behaviours and outcomes (26). To reflect this, our intervention also aimed to promote participant modelling, a key requirement for enhancing self-efficacy (27). A theory-based, 15-minute motivational film was produced by the research team and shown in the first group session to promote group dialogue and peer support (28).
The programme was delivered by an experienced nurse trained in teaching PFME and self-management techniques. PFME were taught both standing, sitting and laying down with 30 minutes of muscle strength training which included muscle endurance and strength with 10 repetitions for each muscle group for both. Discussions were conducted on bladder retraining techniques, fluid management, medication as well as the impact of symptoms on their wellbeing. Modules ran over 10 weeks and comprised four small group sessions (with 5/6 participants), one individual session with the CNS, and two telephone sessions with the CNS (Table 2.) This was followed by four months of at-home self-management. The group sessions were provided within a community leisure facility; face-to-face individual sessions were conducted at a clinical centre. Information booklets were provided in all the group sessions and set homework was discussed at the following group session. Outcome measures were completed at three time points: two weeks prior to the intervention at randomisation (baseline), 3 months and 6 months.
Table 2
Self-Management after Radiation Therapy (SMaRT) intervention and assessment time points
Timeline
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Session
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Content
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Week 0 and − 1 Baseline Assessment (T1)
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Week 1:
90 minutes
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Group session
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Introduction to the programme.
Short motivational peer support film
Exploration of experiences and emotional impact of prostate cancer
Demonstration and group practice of PFME
Information provision
Promotion of daily home exercise (homework)
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Week 2:
40 minutes
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Individual face-to-face session
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One-to-one discussion
Individual problem assessment and goal setting
Review of 7-day bladder diary
Guidance and information around other pelvic late effects (bowel and sexual issues)
Addressing personal and relationship issues
Physical assessment and personal training for PFME
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Week 3:
60 minutes
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Group session
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Group discussion of problem solving and progress
Reinforcement and practice of PFME techniques Introduction of bladder-retraining techniques
Information of managing lower urinary tract medications
Information on sexual dysfunction, bowel problems and ADT
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Week 5:
60 minutes
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Group session
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Sharing experiences and tips
Reinforcement and group practice of PFME
Bladder retraining
Evaluating progress and reviewing goals
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Week 6:
20 minutes
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Individual telephone review
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Reviewing personal goals, motivation and exploration of personal issues.
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Week 7:
60 minutes
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Group session
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Longer-term planning and goals
Reinforcement and group practice of PFME
Discussion on how to maintain PFME
Management techniques for long term symptoms
Open discussion and feedback
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Week 8 Interim Assessments (T2)
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Weeks 10
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Telephone follow-up
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Reviewing personal goals, motivation and exploration of personal symptoms and follow-up plan for the individual.
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Week 25 Final Assessments (T3)
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Abbreviations: PFME Pelvic Floor Muscle Exercises |
The primary outcome was the sum score of urinary symptoms measured by the IPSS at 6 months. Secondary outcomes were: IPSS at 3 months and urinary symptoms measured by the International Continence Society Male Short Form questionnaire (ICSmaleSF); symptom-related quality-of-life measured by the European Organisation for Research and Treatment of Cancer Quality-of-Life scale (EORTC QLQ-PR25), emotional distress measured by the EORTC Quality-of-Life Questionnaire (EORTC QLQ-30); self-efficacy measured by the Self-Efficacy for Symptom Control Inventory (SESCI) at 3 and 6 months.
IPSS self-report questionnaire was used as the primary outcome measure as it is a commonly used clinical assessment tool to measure the degree of LUTs and impact on quality of life with seven questions relating to voiding including: emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. A score of 7 or less is mildly symptomatic, 8–19 is moderately symptomatic and scores from 20–35 indicate severe symptoms (29).
ICSmaleSF a more detailed urinary symptom assessment tool was used to explore urinary functioning and included two distinct LUTs components, voiding (ICSmaleVS) and incontinence (ICSmaleIS). A simple additive score was calculated by adding the 5 items in ICSmaleVC and 6 for ICSmaleIS. The Cronbach’s alpha coefficient for this tool were high at 0.76 for voiding and 0.78 for incontinence symptoms against other measures (30). Both IPSS and ICSmaleSF are generic LUTs measures and not cancer specific, therefore we included more specific prostate cancer measures.
EORTC QLQ-PR 25 is designed for use amongst men with localised and metastatic prostate cancer. Includes subscale assessing urinary symptoms, bowel symptoms, treatment-related symptoms and sexual functioning. Cronbach’s alpha for urinary and sexual scales 0.70–0.86, for other scales < 0.70 (31).
EORTC QLQ-C30 for assessing the quality-of-life of cancer patients which is a reliable and valid measure of quality-of-life of cancer patients in multicultural clinical research settings. Contains five functional scales, global quality-of-life scale and general symptom scales. Cronbach’s alpha across scales 0.52–0.89. This tool is used extensively in clinical research studies worldwide and in our feasibility study (25).
SESCI questionnaire measures three dimensions: i) confidence to perform daily activities; ii) confidence to cope with urinary symptoms; and iii) confidence to manage (change) urinary symptoms. Cronbach’s alpha for total scale 0.97 Cronbach’s alpha for each subscale 0.94 (32).
Sample size calculations and statistical methods
Based on our feasibility study data, a two-sided significance level of 5%, and 85% power, a sample size of 21 evaluable participants per arm was considered sufficient to detect a mean difference of change in IPSS score of 4 points between intervention and control, considered clinically significant. The calculation assumed a standard deviation for change from baseline in IPSS scores of 4.2. To account for possible attrition (withdrawal/loss-to-follow-up) of up to 30%, randomisation was planned to include a minimum of 60 participants.
The primary statistical analysis was undertaken using regression methods (analysis of variance, ANCOVA) to estimate the difference in IPSS scores between groups (intervention vs control) at six months from randomisation together with a two-sided 95% confidence interval, adjusting for baseline IPSS scores and type of radiotherapy which was included as covariate. Where 95% confidence intervals (CIs) do not span zero, the results would be regarded as significant.
For secondary outcomes, the differences between the two groups (intervention vs control) were analysed using regression estimates and 95% CIs obtained through the ANCOVA approach outlined above at both the three and six-months follow-up points.
The analysis was performed as a complete case analysis. To retain the validity of the randomisation, analyses were undertaken according to the intention-to-treat principle and included all consented and randomised patients for whom outcomes were available.