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A nurse-enabled, shared-care model between primary and acute care for prostate cancer survivors (the MOSES-Survivorship study)

A hybrid, implementation-effectiveness trial of a nurse-enabled, shared-care MOdel between primary and acute care for proStatE cancer Survivors (the MOSES-Survivorship study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001552875
Acronym
MOSES-Survivorship
Enrollment
75
Registered
2021-11-15
Start date
2023-05-04
Completion date
2027-12-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

[ Why Are We Doing This Research? ] The purpose of this study is to implement and test the effectiveness of a new care model that will be coordinated by specialist cancer nurses while also involving medical specialists (surgeons, oncologists, and general practitioners/GPs) for follow-up care of people with prostate cancer. [ Who Is It For? ] You may be eligible for this study if you are aged 18 or older and have prostate cancer. [ Study Details ] Participants in this study will be randomly allocated to one of two groups. Participants in one group will be receiving usual, specialist-led follow-up care and information from Cancer Council Australia for up to 5 years. The other group will undergo the nurse-coordinated care model. This involves a series of 30-to-60-minute appointments with specialist nurses, GPs, or hospital cancer specialists every 6 months, for up to 5 years. As part of the study all participants will answer a series of questionnaires at baseline, 6 months, and 12 months. It is hoped this research will demonstrate that the new model of care increases patient quality of life and health care experience and improve prostate cancer follow-up care.

Interventions

This intervention (entitled: MOSES-Survivorship) has been developed through a co-design process with end-users (men with prostate cancer, general practitioners, practice nurses, cancer specialists, and cancer nurses). MOSES-Survivorship strategically uses prostate cancer specialist nurses (PCSN's) - an existing workforce embedded in the health system - to implement a shared, follow-up care model between acute cancer care centres and general practices for people diagnosed with prostate cancer. PC

This intervention (entitled: MOSES-Survivorship) has been developed through a co-design process with end-users (men with prostate cancer, general practitioners, practice nurses, cancer specialists, and cancer nurses). MOSES-Survivorship strategically uses prostate cancer specialist nurses (PCSN's) - an existing workforce embedded in the health system - to implement a shared, follow-up care model between acute cancer care centres and general practices for people diagnosed with prostate cancer. PCSN's are trained and supported to (1) engage all stakeholders (patients, families, general practitioners, specialists, and allied health) to take an active role in cancer survivorship care in a shared, follow-up care model; (2) ensure timely information exchange and negotiation of shared-responsibilities through multidisciplinary case conferencing (Medical Benefits Schedule MBS - Item 750); and (3) ensure general practitioners and practice nurses have access to a survivorship care plan and a range of evidenced-based tools and resources. The intervention explicitly provides shared-care (interchanging specialist and general practice appointments during follow-up cancer care for men with prostate cancer) and enhanced care (overlaying general practice appointments with specialist appointments during follow-up care), depending on the clinical needs of the men with prostate cancer who are randomised to the intervention. During active surveillance (Group 1), at completion of curative intent treatment for localised prostate cancer defined as end of surgery or radiation therapy, whichever was delivered last (Group 2), or presenting with metastatic prostate cancer (Group 3), patients will be enrolled in the study, and randomised. For the intervention: 1 x 30-60 minute face-to-face or telehealth Prostate Cancer Specialist Nurse consult with the participant 8+/-2 weeks post-enrolment to: 1) provide treatment summary; 2) provide survivorship patient education including a written survivorship booklet on “Living Well After Cancer” published by Cancer Council Australia; 3) co-develop a draft Survivorship Care Plan (SCP) including SMART goals (using motivational interviewing and self-efficacy techniques); and 4) provide a draft post-treatment shared-care follow-up appointment schedule. A draft SCP (including the treatment summary) will be provided to the participant via email or post and their nominated GP via GP clinic preferred communication system. Adherence to the nurse-led clinic and its components will be monitored using a nurse-led clinic checklist. 1 x 20–30-minute video/telephone case-conference between the Prostate Cancer Specialist Nurse and GP (+/- GP practice nurse) within 4 weeks of Specialist Cancer Nurse consult to finalise the SCP and negotiate the GP’s role in facilitating SCP SMART goals as well as seek agreement on the shared-care follow-up appointment schedule. Adherence to the GP case conference and its components will be monitored using a GP case conference checklist. Up to 11 (depending on how far post-enrolment the patient is when they enter the study) alternating 6-monthly face to face or telehealth (as per clinician) patient appointments with cancer specialist or GP for 5 years will occur (for shared-care arrangements) or up to 11 additional 6-monthly face-to-face or telehealth (as per clinician) patient appointments with the GP in addition to the cancer specialist for 5 years will occur (for enhanced-care arrangements). At 5 years the patient will be discharged to the care of the GP. Appointment durations for the cancer specialist or the GP will vary depending on patient needs (approximately 10 to 30 minutes each). More specifically: 5 x GP appointments at <12- (initial), 18-, 30-, 42- and 54- months post-enrolment for review of SCP, general health, screening/management of comorbidities, psychosocial health cancer treatment toxicities, cancer-related symptoms, chronic disease management planning, allied health referrals and physical examinations (if required/agreed). The GP appointments duration will vary depending on participant need. Additional appointments with the GP can be scheduled if clinically indicated. The GP will have direct telephone access to the Prostate Cancer Specialist Nurse in case of concerns or escalation for acute care review. Adherence to the minimum GP appointment schedule will be monitored using MBS data. 6 x cancer specialist appointments at 12-, 18-, 24-, 36-, 48- and 60-months post-enrolment for review, physical examination, and imaging. The cancer specialist appointments duration will vary depending on participant need. Additional appointments with the cancer specialists can be scheduled if clinically indicated. Adherence to the minimum specialist appointment schedule will be monitored by checking medical records and hospital appointment scheduling data.

Sponsors

Professor Raymond Chan
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Men with confirmed adenocarcinoma of the prostate (i.e., men with prostate cancer), who have (a) localised prostate cancer and being monitored through active surveillance, (b) localised prostate cancer (low, intermediate, or high risk) and have completed their primary curative intent treatment (surgery or radiation therapy) within the past 3 years, or (c) have had a diagnosis of metastatic prostate cancer for at-least 3 months or more. Men must be 18 years of age or older; be able or willing to identify a usual GP or General Practice; be ambulatory with a Eastern Co-operative Oncology Group (ECOG) performance status of 0 to 2; have access to a telephone; and be-able to speak and read English.

Exclusion criteria

People will be excluded if they do not have prostate cancer; present with severe mental, cognitive or physical conditions or other circumstance that would limit the patient’s ability to participate at the discretion of treating clinicians; are judged to have <6 months of life expectancy at the discretion of the treating cancer specialist (urologist/oncologist); or who are unable to provide consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026