Getting the MOST out of follow-up: a randomized controlled trial comparing 3 monthly nurse led follow-up via telehealth, including monitoring CA125 and patient reported outcomes using the MOST (Measure of Ovarian Symptoms and Treatment concerns) with routine clinic based or telehealth follow-up, after completion of first line chemotherapy in patients with epithelial ovarian cancer.

BACKGROUND: Physical symptoms, anxiety, depression, fear of recurrence, sexual dysfunction, and social withdrawal are common in women after treatment for ovarian cancer. Most patients would like and need help dealing with these symptoms. The traditional model of follow-up care is unstructured and largely focused on diagnosing recurrent disease, and most oncologists lack skills to identify and manage psychosocial issues. No high quality prospective clinical trials have been conducted to determine the optimal follow-up regimen or the cost effectiveness of ovarian cancer surveillance strategies. PRIMARY OBJECTIVES: To assess emotional wellbeing, acceptability, safety, and cost effectiveness of nurse led follow-up via telehealth for women with ovarian cancer following completion of primary treatment. STUDY HYPOTHESIS: We hypothesize that compared with routine clinic based follow-up, nurse led follow-up via telehealth, including serum CA125 monitoring and completion of a patient reported outcome instrument, the Measure of Ovarian Symptoms and Treatment concerns-Surveillance (MOST-S26), will improve emotional wellbeing in women with ovarian cancer; be feasible, safe, acceptable, and not delay the time to diagnosis of recurrent disease; will result in greater patient satisfaction; will identify more patients with psychological distress, lead to better care, and improved psychological outcomes; and be cost-effective. TRIAL DESIGN: Phase II multicenter randomized trial comparing 3 monthly nurse led telehealth consultations that include serum CA125 monitoring and completion of the MOST-S26, with routine clinic based follow-up. The allocation ratio will be 1:1. MAJOR INCLUSION/EXCLUSION CRITERIA: Eligible patients will be women with high grade epithelial ovarian cancer who have normalized serum CA125 (to <35 kU/L) at completion of first line chemotherapy. PRIMARY ENDPOINTS: Emotional wellbeing at 12 months. SAMPLE SIZE: 150 patients. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: July 2023. Results expected in 2025, 24 months after the last participant is enrolled. TRIAL REGISTRATION: ACTRN12620000332921.

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

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.

Evaluating a multicomponent survivorship programme for men with prostate cancer in Australia: a single cohort study.

OBJECTIVE: To evaluate the implementation of a multicomponent survivorship programme for men with prostate cancer and their carers. DESIGN: A single cohort study, guided by the RE-AIM framework. SETTING: Multiple health services in Australia. PARTICIPANTS: Men with prostate cancer and their carers, and health professionals. INTERVENTION: A 12-month telehealth programme that provided centralised and coordinated decision and information support, exercise and nutrition management, specialised clinical support and practical support to men and their carers. DATA COLLECTION: Multiple sources of data including participant-reported health outcomes and experience of care, qualitative interviews, records of the programme were collected at different time points. RESULTS: Reach: Of 394 eligible men at various stages of survivorship, 142 consented (36% consent rate) and 136 (96%) completed the programme. Adoption: All men participated in general care coordination and more than half participated in exercise and/or nutrition management interventions. Participation in the specialised support component (ie, psychosocial and sexual health support, continence management) was low despite the high level of need reported by men. Effectiveness: Overall, the men reported improvements in their experience of care. Implementation: Factors such as addressing service gaps, provision of specialised services, care coordination, adoption of needs-based and telehealth-based approaches were identified as enablers to the successful implementation of the programme. Issues such as insufficient integration with existing services, lack of resources and high caseload of the intervention team, men's reluctance to discuss needs and lack of confidence with technology were barriers in implementing the programme. CONCLUSION: Survivorship interventions are relevant to men regardless of the stage of their disease and treatments undertaken. It is possible to provide access to a comprehensive model of survivorship care to promote the health and quality of life for men with prostate cancer. TRIAL REGISTRATION NUMBER: This study was registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12617000174381).

TAKING ACTION TO IMPROVE OUTCOMES FOR MEN LIVING WITH AND BEYOND PROSTATE CANCER.

In Australia prostate cancer is the most commonly diagnosed cancer in men, with around 20,000 diagnosed each year (AIHW 2013, 2014). The many who survive it often battle with significant side-effects from treatment such as incontinence, loss of sexual function, fatigue and psychology issues.