A pilot randomised controlled trial of personalised care after treatment for prostate cancer (TOPCAT-P): nurse-led holistic-needs assessment and individualised psychoeducational intervention: study protocol

Abstract

IntroductionProstate cancer is common and the incidence is increasing, but more men are living longer after diagnosis, and die with their disease rather than of it. Nonetheless, specific and substantial physical, sexual, emotional and mental health problems often lead to a poor quality of life. Urology services increasingly struggle to cope with the demands of follow-up care, and primary care is likely to play the central role in long-term follow-up. The present phase II trial will evaluate the feasibility and acceptability of a nurse-led, person-centred psychoeducational intervention, delivered in community or primary care settings.Methods and analysisProstate cancer survivors diagnosed in the past 9–48 months and currently biochemically stable will be identified from hospital records by their treating clinician. Eligible men would have either completed radical treatment, or would be followed up with prostate specific antigen monitoring and symptom reporting. We will recruit 120 patients who will be randomised to receive either an augmented form of usual care, or an additional nurse-led intervention for a period of 36 weeks. Following the health policy in Wales, the intervention is offered by a key worker, is promoting prudent healthcare and is using a holistic needs assessment. Outcome measures will assess physical symptoms, psychological well-being, confidence in managing own health and quality of life. Healthcare service use will be measured over 36 weeks. Feedback interviews with patients and clinicians will further inform the acceptability of the intervention. Recruitment, attrition, questionnaire completion rates and outcome measures variability will be assessed, and results will inform the design of a future phase III trial and accompanying economic evaluation.Ethics and disseminationEthics approval was granted by Bangor University and North Wales REC (13/WA/0291). Results will be reported in peer-reviewed publications, at scientific conferences, and directly through national cancer and primary care networks.Trial registration numberISRCTN 34516019.

A pilot randomised controlled trial of a multimodal supportive care (ThriverCare) intervention for managing unmet supportive care needs in men with metastatic prostate cancer on hormonal treatment and their partner/caregivers

“…A number of studies have examined the clinical utility of PRO holistic needs assessment (Bonevski et al, 2000). To the best of our knowledge, this is the first pilot RCT to demonstrate an improvement in supportive care experience for men affected by metastatic prostate cancer through the use of PRO HNA's in clinical practice, elsewhere studies are currently on-going (Snowden et al, 2015;Stanciu et al, 2015). As a strengthen to our study, we implemented the Prostate Cancer Model of Consultation as part of the HNA process (Paterson and Nabi, 2016) which enabled precise standardization of evidence-based self-management interventions tailored to the individual area of need.…”

“…Arguably, the completion of HNAs questionnaires in clinical practice alone, are of no benefit or can worsen unmet supportive care needs experience, if the clinician does not discuss the unmet needs information documented in the consultation, or if the clinician does not have access to precise evidence-based self-management interventions to support or advice the patient appropriately. A methodological limitation of studies elsewhere (Snowden et al, 2015;Stanciu et al, 2015) is that they do not clearly evidence the standardization of the intervention content following the completion of the HNA. Inevitably, this will create the opportunity for bias because healthcare professionals vary in experience, knowledge and expertise in their ability to develop shared self-management plans to address unmet physical, emotional, spiritual, environmental, social, sexual, financial and cultural needs.…”

Trial of personalised care after treatment-Prostate cancer: A randomised feasibility trial of a nurse-led psycho-educational intervention

“…The study excluded men awaiting curative treatment or monitored until proof of progression (active surveillance), in the terminal stage of their disease, who lacked capacity, or with cognitive, visual or neurological impairments that would impede completing the trial (as assessed by the referring clinician). Ninety‐five participants were recruited by blinded selection and individually randomised to Intervention ( N = 48) or Control ( N = 47) groups, on a 1:1 basis and balanced for age quartiles (see Stanciu et al, ; Supporting Information Appendix ). Participant allocation was revealed to patients and researchers after recruitment.…”

“…Patients in the Intervention group received the above, followed by an initial appointment with the Research Nurse for a holistic needs assessment, and as many tailored follow‐up appointments as appropriate (by agreement with the Research Nurse). Further details about the training undertaken by the nurse, the rationale and the description of the intervention have already been published (Stanciu et al, ).…”

“…Provisions were made to record all adverse events and serious adverse events and to follow them up for the duration of the study or until resolution. Data management strategy is reported elsewhere (Stanciu et al, ).…”