A pilot study to assess the feasibility of an integrated survivorship intervention to improve patient and service level outcomes for men with prostate cancer. ‘The True NTH Pilot Study’

1. Care Coordination A locally based care coordinator and the central care coordination service will work collaboratively to implement the coordination interventions, including screening and assessment, navigation and ongoing monitoring. Men who meet the inclusion criteria will be identified by the treating team, who will refer the man to the True NTH coordinator as early as possible in the care pathway. Following referral to the True NTH service by the treating team, the local care coordinator will undertake a comprehensive screening and assessment process in a structured face to face consultation. This initial screening and assessment is communicated to the treating team and provides the basis for development of a care plan and referral to other relevant True NTH services. All men will then be provided with a technology supported platform which enables them to undertake ongoing self-monitoring of symptoms and needs on a 3 monthly basis, or when new symptoms emerge. An alert will be sent to the True NTH care coordinator and general practitioner when assessments are completed. On the basis of these assessments, navigation to the following services will occur: a)Central Coordination Service; b)Practical support; c)Lifestyle Plan; and d) Peer group. Not all men will need to access all of the True NTH intervention components. The man will only be referred to the components needed, as identified during screening and assessment, and agreed by the treating specialist/team. 2. Information Provision and Decision Support At the time of recruitment, the care coordinator will make available to the man and their carer the appropriate education and decision support material relevant to their stage of disease and treatment. The education package will include evidence based patient education booklets according to need. The local care coordinator will provide a one-to-one instructional session with the patient and carer, tailoring information to patient and carer needs. The local care coordinator will also provide self management messages to reinforce key messages for preventing and responding to physical or psychological symptoms, drawing on evidence based information included in the information and education packages. The local care coordinator will introduce men with localised prostate cancer to an online decision support aid - the Personal Patient Profile - Prostate (P3P) Decision Support Aid1, which will be modified to suit the Australian context (language/text, definitions, statistics, videos and weblinks). The treating team will access the information gained from the patient’s use of the decision support aid to facilitate discussion regarding treatment choices. 3. Practical Support The local care coordinator and central True NTH services will refer the man to relevant support services to address practical needs relating to transport, accommodation, finance and advance care planning. These referrals will be based on assessment of needs and preferences. Local service registries will be developed to support referral, with reference to True NTH Specialist Services where local services are unavailable to meet the man’s needs. 4. Peer Support The local care coordinator and central coordination service will provide information to the man and his carer about a range of peer support programs. The list of local services will be developed following the initial mapping of local peer support initiatives and advice from Prostate Cancer Foundation Australia and Cancer Council contacts. 5. Lifestyle Plan 1) Exercise An appropriately prescribed, evidence-based exercise prescription developed by researchers at Edith Cowan University (ECU) will be provided to men regardless of their stage of disease, past, current or future treatments, financial capacity or geographic location. The program will be delivered through multiple modes, depending on available resources, including: a)Face-to-face consultations with an accredited exercise physiologist (AEP); b)Telephone or online teleconference with an AEP; c)Online delivery via a web site with customisation to the individual’s requirements and contraindications; d)DVD exercise programs with generic prescriptions for men at different stages of disease and treatment; e)Paper based exercise programs with generic prescriptions for men at different stages of disease and treatment. For an exercise clinic staffed by AEPs, laboratory standard tests will be applied. The AEP will provide initial face to face assessment, develop a tailored exercise prescription and support the man remotely as required over time to maintain adherence to the program, adjusting as needed. Where no EP is available, telehealth assessment and ongoing support will be provided, drawing on the support of other allied health, medical and nursing professionals where appropriate. The exercise assessment and prescription will be provided from Edith Cowan University (ECU). The exercise prescriptions will be tailored to the individual to address the specific issues causing greatest concern or to prepare them for future treatments such as surgery, or to address post-treatment issues. That is, the exercise physiologist will deliver a structured program relevant to the man’s disease stage. The program will include the following components: a)The man undergoing a curative treatment option prostatectomy or radiation oncology will undertake a 6-8 week exercise program in readiness for treatment incorporating a pelvic floor exercise program; b)All other men will have an exercise program tailored for them individually by an exercise physiologist following the Exercise and Sports Science Australia (ESAA) guideline for cancer; c)Men with advanced prostate cancer will have a specialised exercise program focused on impact exercise for those receiving ADT or with bone metastasis. Regular monitoring of the man will ensure safety as well as providing motivation to continue to adhere to the exercise prescription. To facilitate this, the latest technology for biometric monitoring will be used to track key fitness and health measures. This will be coordinated through ECU using their online data collection systems. 2) Nutrition True NTH will provide access to services of a dietician either locally or through central coordination services, depending on the capacity of the local health service and preferences of the man. The man will undergo an initial nutrition screening using the Malnutrition Screening Tool and calculating body mass index (BMI). In addition to the initial screening for malnutrition and excess weight at referral to the True NTH local care coordinator, additional screening points will include: a)At completion of curative treatment or those on active surveillance; b)At diagnosis of advanced prostate cancer and then at 3 monthly intervals. If identified to be at risk at any screening point, men are referred to an Accredited Practicing Dietitian (APD) for a comprehensive nutritional assessment. This referral will be to a local APD where available, or to a central care coordinator who will facilitate referral to an APD if no local service is available. 6. Specialised Support Services The local care coordinator will work with the local treating teams to match services to the needs and preferences of the man and their carer at entry to the True NTH program and at any point during the study intervention phase. The navigation will involve referral to the following specialist services where required: 1)Psychological services The local care coordinator will undertake the initial screening using the ‘distress thermometer’ and identify factors associated with any distress. Men with mild or moderate anxiety and/or depression will be referred to an online self management program. The self-management program focuses on developing skills to manage distress and is delivered by Mindspot. For men with moderate or high level needs at referral or at any follow up assessment, referral will be made to: a)Psychological support services within the treating service where available; b)Remote psychological support services coordinated by the central coordination service, and delivered by staff from Peter MacCallum Cancer Centre. 2)Sexual health At referral to the local care coordinator, all men will receive standard information and education relating to sexual health issues. Assessment and ongoing monitoring will identify men with sexual health needs who require additional services. These men will be referred to a local sexual health counsellor where available or referred to a specialist service from the centralised True NTH service where local services are not available. 3)Continence services At referral to the local care coordinator, all men will receive standard information and education relating to continence issues. Assessment and ongoing monitoring will identify men with continence needs who require additional services. These men will be referred to local continence advisors where available and/or referred to the Continence Foundation Australia (CFA) if such services are not available. CFA will liaise with the treating specialist team to contribute to a continence plan through advice and expertise. 7. Advance Prostate Cancer Comorbidities management On enrolment to the study, the local care coordinator will liaise with the patient’s GP to facilitate the following assessments: a)For men with localised prostate cancer an assessment for comorbidities, using RACGP Guidelines; b)For men with advanced prostate cancer, a specific set of tests and measures for osteoporosis, cardiovascular disease, obesity and diabetes. Based on this assessment the GP will be provided with care plan guidelines to facilitate management of any identified risks and conditions. The lifestyle component of the True NTH intervention will also support the man to minimise risk of ADT adverse effects as well as those from other treatments for men with advanced prostate cancer. While each component of the intervention is available for all men, the intervention and each of its components are tailored to the patient’s stage of disease and their health related needs. Delivery of specialised support services will depend on resource availabililty, access, treating specialist /team preference and preference of the man. The service model incorporates centralised coordination and referral to specilist services where required, as it is acknowledged that all services may not be available at a local region. The total duration of the intervention is 6 months.