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An integrated multicomponent care model for men affected by prostate cancer: A feasibility study of TrueNTH Australia

Abstract Objective To evaluate the feasibility of implementing an integrated multicomponent survivorship care model for men affected by prostate cancer. Methods Using a single arm prospective cohort study design, men with prostate cancer were recruited from two regional public hospitals in Australia for a 6‐months program that provided information and decision support, exercise and nutrition management, specialised clinical support, and practical support through localised and central care coordination. Carers of the men were also invited to the program. Data were collected from multiple sources to evaluate: (1) recruitment capability and participant characteristics; (2) appropriateness and feasibility of delivering the specific intervention components using an electronic care management tool; and (3) suitability of data collection procedures and proposed outcome measures. Results Of the 105 eligible men, 51 (consent rate 49%) participated in the program. Of the 31 carers nominated by the men, 13 consented (consent rate 42%). All carers and 50 (98%) men completed the program. Most (92%) men were newly diagnosed with localised prostate cancer. All men attended initial screening and assessment for supportive care needs; a total of 838 episodes of contact/consultation were made by the intervention team either in person (9%) or remotely (91%). The intervention was implemented as proposed with no adverse events. The proposed outcome measures and evaluation procedures were found to be appropriate. Conclusions Our results support the feasibility of implementing this integrated multicomponent care model for men affected by prostate cancer.


| INTRODUCTION
Approximately 20,000 men are diagnosed with prostate cancer each year in Australia and 95% of them live at least 5 years after diagnosis. 1 The prostate cancer survivorship starts at the time of initial diagnosis and treatment and remains the rest of life, 2 in which men face various challenges associated with complex treatment decisions, treatmentrelated side effects, psychological distress and the prospect of recurrence or progression of disease. Urinary incontinence and erectile dysfunction are the most common treatment-related side effects following radical prostatectomy that negatively impact quality of life.
Other common treatment-related side effects include bowel urgency from radiation therapy, and deterioration in body composition, physical function, cardiometabolic toxicity and loss of libido and physical feminisation from androgen deprivation therapy. [3][4][5][6] Additionally, men can experience acceleration of comorbid conditions associated with their cancer treatment, such as osteopenia and osteoporosis, cardiovascular disease, diabetes and obesity. 6 The complexity of these disease-and treatment-related effects mean that many men with prostate cancer are at risk of or experience unmet supportive care needs. Carers of these men report unmet needs in relation to information and health care services, 7 with some studies reporting that carers can experience greater distress than the men. 8,9 To promote comprehensive follow-up care and improve quality life of men with prostate cancer, the American Cancer Society (ACS) and American Society of Clinical Oncology (ASCO) Prostate Cancer Survivorship Care Guidelines 10,11 identify five key domains for action: health promotion, surveillance, physical side effects, psychosocial management, and care coordination. A number of studies have conducted interventions to address these key areas of care. Exercise and psychosocial interventions have been shown to improve men's health promotion and psychosocial outcomes and reduce physical side effects. [12][13][14] Supported self-management interventions have been shown to be comparable to traditional follow-up care 15 and enhance sexual and urinary function. 16 Nutrition interventions, 17 with or without aerobic exercise, are efficacious in reducing body mass in overweight and obese men with prostate cancer. Studies of family/ couple-based interventions also report benefits for carers, such as improved information and psychosocial support, better coping and adjustment to the disease. 14,18 While evidence for prostate cancer survivorship care interventions has grown over the last decade, most studies to date have focused on one area of care, with single intervention approaches that report only on the short-term effects. These studies often fail to recognise that many men and their carers have multiple supportive care needs that can exist over extended periods of time. 2 It is noteworthy to mention that the design and implementation for long-term comprehensive survivorship interventions are sometimes restrained due to issues such as short funding periods and privately insured health care systems.
Recent literature highlights the need to develop comprehensive models of survivorship care that recognise the multiple co-existing and changing requirements that men with prostate cancer experience, and the many service providers that need to be engaged to prevent and manage these needs over time. 2

| Setting and sample
Based on the capacity and readiness to implement the intervention, two regional public health services from Queensland and New South Wales were selected to participate. Men were eligible if they: (1) were diagnosed with localised prostate cancer within the last 3 months or diagnosed with advanced prostate cancer at least 12 months prior to the recruitment period; (2) were able and willing to participate in the intervention and complete patient reported outcome assessments; and (3) nominated a general practitioner (GP) who agreed to use an online care management tool. Men were excluded from the study if they: (1) were too unwell (as determined by their treating specialists); or (2) had physical, psychological or cognitive difficulties that would prevent them from participating in the intervention or completing self-report outcome measures. The treating specialist (e.g., urologist, radiation or medical oncologist) introduced the study to the potential participants when they attended clinic appointments at the site. Men who expressed interest were referred to an on-site research nurse (who operated independently from nurses delivering the intervention) for further study information and written consent. Upon consenting, men were asked to nominate a GP who was subsequently sent written information about the study. Verbal consent to participate was obtained from the GP via a follow-up telephone conversation with the research nurse.
All consented men were asked to nominate one partner/carer, who was also invited to participate. Partners/carers were required to be: (1) aged 18 years or older; (2) competent to give informed consent; and (3) able to complete questionnaires. Participation of the partner/carer was not a requirement for the man to participate in the study.

| Intervention
The TrueNTH intervention was a multi-component integrated model Partners/carers were encouraged to attend the session with the man F I G U R E 1 Components of the TrueNTH program and care pathway for men with prostate cancer and were provided with support as appropriate, which included the provision of relevant information.
The outcome of the initial assessment was communicated to the man's treating specialist/team and GP via email or postal mail. This information was used as the basis for development of a care plan and referral to appropriate specialist support services according to the man's health needs and preferences, preference of treating specialist/team and the availability of local resources. The local care coordinator liaised with the man's GP to facilitate additional assessments for risks or comorbidities. Based on the assessment, the GP liaised with the treating team to facilitate the management of any identified risk factors and conditions. All men were referred to an accredited exercise physiologist and an accredited practising dietitian either locally or through a centralised service to receive an evidence-based exercise prescription and individualised dietetic services, respectively. They were provided with information about local peer support programs and were referred to relevant support services to address their needs relating to transport, accommodation, finance, legal, employment and respite services for carers, as required.
The above services were offered to all men regardless their stage of prostate cancer and treatment received. The needs for specific prostate cancer related services (as shown in Figure 1) varied by men's stage of disease and treatment received and thereby the specialised services were by referral at any point during the intervention according to needs. These services were delivered locally where available or remotely by a central specialist service engaged for the purposes of this project. Not all men needed all specialised services.
To ensure the intervention fidelity, a detailed intervention manual was provided to the care coordinators. All staff involved in the intervention delivery attended an orientation and skill development program, ongoing education and training as required, and regular team meetings. An online care management tool (cdmNet 1 ) was used to manage and support care planning, delivery, and review of the services by the intervention team. Men were provided with this tool at the initial consultation, which enabled them to access the individualised care plan and undertake ongoing self-monitoring of their symptoms and needs on a 3 monthly basis or when new symptoms emerged. An alert was sent to the local care coordinator and GP when assessments were completed. If the man did not want to use cdmNet to communicate with the care team or access information, hard copies of information and the care plan were provided with telephone support.

| Recruitment capability and resulting participant characteristics
The primary outcome for this study was feasibility measured by the number of eligible patients in the targeted population, number of consents, reasons for declining participation, and retention rate. These measures were documented by the research nurse responsible for recruitment using structured forms.

| Appropriateness and feasibility of delivering intervention components
Information on intervention delivery and attendance were captured by cdmNet. After each initial consultation, the local care coordinators also completed a log to record the extent to which they delivered intervention activities and the length of the session. Seven sessions were audio-recorded with permission from the participants to enable assessment of the fidelity of the intervention delivery to protocol.

| Suitability of data collection procedures and proposed outcome measures
Surveys were conducted with participants at enrolment (T 0 ), and at 3 months (T 1 ) and 6 months (T 2 ) after enrolment. A range of validated questionnaires (Appendix S1) was used to measure patient-reported health outcomes, including prostate cancer-specific quality of life (EPIC-26), 22 psychological well-being (GHQ-12), 23,24 experience of care (PPE-15), 25 supportive care needs (SCNS-SF34), 26 and decisional conflict 27 /regret. 28 The proposed economic outcome measures, including three health-related quality of life measures (i.e., EQ-5D-5L, 29 AQoL-8D 30 and FACT-P 31 ), self-reported health service usage and cost data were also collected via the survey. The T 0 survey was completed by participants at the clinic on the day of the initial consultation and follow-up questionnaires were posted to the participants with pre-paid return envelopes. The research nurse would aid participants if required. Participants were informed that their responses were confidential and not supplied to their care providers.

| Data analysis
All quantitative analyses were performed using SPSS for Windows

| Recruitment capability and participant characteristics
During the recruitment period between 2015 and 2016 (one site recruited for 6 months and another site recruited for 12 months), a total of 183 men with prostate cancer were referred to the study (see Figure 2). Of the 105 eligible men, 51 consented (consent rate 49%); of the 31 nominated carers, 13 consented (consent rate 42%).
Baseline demographic characteristics of participants are presented in Table 1. Most men (n = 47, 92%) were newly diagnosed with localised prostate cancer at enrolment; among them 70% (n = 33) received surgery, 13% (n = 6) received radiotherapy, 6% (n = 3) received multiple treatments, and 11% (n = 5) were undergoing active surveillance during the study. Of the four men with advanced prostate cancer, three were undergoing hormone treatment and one had completed surgery at enrolment.

| Local care coordinator interventions
All men attended the initial consultation with the local care coordinators at enrolment. The themes identified from these sessions are presented in Table 2. The extent to which various components of the intervention were addressed in these sessions is reported in Appendix S2. During the session, information and education com-   IPTAAS is a subsidy program which provides financial assistance to help with travel and accommodation costs for people who need to travel long distances to access specialist medical services not available locally.

| Number and delivery mode of intervention components
c Medicare data are health related statistics administered by the Australian government which provide information on general practitioner, specialist, diagnostic test and prescription pharmaceutical use.

Themes Examples
Screening and assessment � Assessment of prostate cancer specific symptoms, distress and nutrition screening using the tools as per protocol. � Assessment of prostate cancer stage, treatments received or treatment intention, medication, and comorbidities.

| Data collection procedures and outcome measures
All The recruitment resulted in a sample of men who were of a similar age range to men affected by prostate cancer in Australia. 1 Most men were from a regional area and one third of them had to travel long distances (eligible for government subsidy) for treatment and specialist appointments. Around 40% took time off work to participate in the face-to-face services. Therefore, interventions that are delivered remotely via telephone or digital health were appropriate and acceptable for the current sample. We suggest that while some men were reluctant to participate in the study due to concerns about use of technology, most intervention activities (91%) were carried out remotely via telephone or digital health.
In terms of the data collection procedures and outcome mea- -1551 of the EQ-5D-5L and the AQoL-8D is that generic health utility scores can be generated for comparative economic evaluation purposes (i.e., both instruments are multi-attribute utility instruments (MAUIs) usable in a variety of settings). 32 The AQoL-8D has more sensitivity to change than the EQ-5D-5L but is considerably longer. Both have been extensively used in trials to describe the self-rated health, but the EQ-5D-5L has had greater application in prostate cancer patients. 33 As a result, the EQ-5D-5L would be recommended for a larger study as the preferred economic instru-

| Clinical implications
Overall, the uptake of intervention components was high, and the intervention was implemented as proposed. This included uptake of the referral to remotely provided nutrition and exercise management services, and other support following treatment completion. Smaller numbers of referrals were made to specialised services including sexual counselling, continence, and psychological services. These lower referral rates could reflect that such referrals were seen to be necessary only for severe cases or reflect reluctance on the part of local care coordinators to share care with others. It might also reflect reluctance on the part of patients to accept help for these concerns.
A previous study 34  written by care coordinators. It was also challenging to monitor and obtain data on the services provided by the local service providers outside of the public health system. The barriers to using the tool for these health professionals need to be explored as effective communication within the patients' care team and care coordination across service providers and settings are key to the successful management of patient care.

| Study limitations
This study was designed to assess the feasibility and acceptability, but not the effectiveness of the intervention. Nonetheless, some

| CONCLUSIONS
In this study we have demonstrated the feasibility of implementing an integrated multicomponent care model for men affected by prostate cancer. Future studies need to focus on how to engage with men and their partners/carers to ensure similar interventions take into account their concerns and to reduce burden. Consideration of health literacy and tailoring of the intervention to personal circumstances are integral to success of long-term interventions such as TrueNTH. Additional strategies to encourage the involvement of GPs, if they are to take on a more active role in follow up care, are needed.
Clear protocols that guide when referrals should be made to specialist support services will be required to ensure appropriate use of these services.