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Implementing a nurse-coordinated, integrated, shared-care model involving specialists and general practitioners in breast cancer post-treatment follow-up: a Phase II randomised controlled trial

ImplEMenting a nurse-coordinated, INtegrated, shared-care model involving specialists and general practitioners in breast cancer post-treatmENT follow-up: a Phase II randomised controlled trial (The EMINENT Trial)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001594112
Acronym
EMINENT
Enrollment
63
Registered
2019-11-19
Start date
2019-12-03
Completion date
2021-04-23
Last updated
2025-10-13

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

Conditions

None listed

Brief summary

The purpose of this study is to test the feasibility of a care model involving specialists and GPs for early breast cancer post-treatment follow-up. Who is it for? You may be eligible for this study if you are aged 18 or older, and have recently completed treatment for breast cancer. Study details Participants in this study will be randomised by chance (like flipping a coin) into two groups. One group will receive standard follow-up (specialist lead) care and information from Cancer Council Australia. The other group will undergo the share-care model. This involves a series of 20 to 60 minute appointments with specialist nurses, GPs and cancer specialists for up to 5 years. As part of the study all participants will answer a series of questionnaires every 3 months for 12 months. It is hoped this research will demonstrate the feasibility and usefulness of the new model of care which could influence future post-treatment cancer care.

Interventions

At completion of treatment [i.e., end of surgery, or adjuvant chemotherapy/ radiation therapy (whichever was delivered last)], patients will be enrolled in the study. Group 1 (The shared-care group): 1 x 20 minute Cancer Pharmacy consultation for medication reconciliation and education prior to specialist nurse consult (only patients who completed chemotherapy, radiotherapy or those who will receive aromatase inhibitor). 1 x 30-60 minute Specialist Nurse consult with patient 8+/-2 weeks post-tr

At completion of treatment [i.e., end of surgery, or adjuvant chemotherapy/ radiation therapy (whichever was delivered last)], patients will be enrolled in the study. Group 1 (The shared-care group): 1 x 20 minute Cancer Pharmacy consultation for medication reconciliation and education prior to specialist nurse consult (only patients who completed chemotherapy, radiotherapy or those who will receive aromatase inhibitor). 1 x 30-60 minute Specialist Nurse consult with patient 8+/-2 weeks post-treatment to: 1) provide survivorship patient education; 2) treatment summary; 3) co-develop a Survivorship Care Plan (SCP) including SMART goals (using motivational interviewing and self-efficacy techniques); and 4) follow-up appointment schedule. A completed draft treatment summary and SCP will be provided to the patient and the GP. A 'booster' nurse consult will be offered to patient where there delays greater than 3 months in GP involvement (up to 18 months) to update the SCP, where necessary. 1 x 20-30 minute case-conference between specialist nurse and GP within 4 weeks of nurse consultation to discuss intervention follow-up schedule, the draft SCP with the GP and negotiate GP role in facilitating SCP goals. 11 x alternating 6-monthly patient appointments with cancer specialist or GP for 5 years. At 5 years the patient will be discharged to the care of the GP. More specifically, 5 x GP appointments at <12 (initial), 18, 30, 42 and 54 months post-diagnosis for review of SCP, general health, and screening/management of comorbidities, psychosocial health cancer treatment toxicities, cancer-related symptoms; chronic disease management planning and allied health referrals. The GP will have direct telephone access to the specialist nurse in case of concerns or escalation for acute care review. 6 x cancer specialist appointments at 12, 18, 24, 36, 48 and 60 months post-diagnosis for review, physical examination and imaging (i.e., annual mammogram) at 12, 18, 24, 36, 48 and 60 months post-diagnosis. - A log of all consultations will be kept by treating nurse

Sponsors

Professor Raymond Chan
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

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

Inclusion criteria

Patients who - are treated at the Princess Alexandra Hospital - following criteria will be considered for inclusion in the study: - are from 4 weeks pre-completion up to 18 months after completion of adjuvant treatment for early stage breast cancer patients (including Ductal Carcinoma In-Situ (DCIS) and locally advanced) at the Princess Alexandra Hospital; OR within 4 weeks to 18 months post-surgery if they are not scheduled for any further adjuvant therapy - have received a diagnosis of curable early breast cancer (i.e. no distant metastases); - are able to speak and read English; - are at least 18 years of age; - are ambulatory patient at the time of recruitment; - have an Eastern Cooperative Oncology Group performance status 0 or 1; - are able to nominate a GP or GP clinic to be involved in their follow-up; and - have access to a telephone.

Exclusion criteria

- the presence of severe mental, cognitive or physical conditions that would limit the patient’s ability to participate. - breast cancer recurrence - presence of distant metastases

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 25, 2026