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Evaluating the impact of a nurse-led clinic model of care on the symptom management of women prescribed adjuvant endocrine therapy for early breast cancer

Evaluating the impact of a nurse-led clinic model of care on the symptom management of women prescribed adjuvant endocrine therapy for early breast cancer: a quasi-experimental pilot study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000573358
Enrollment
40
Registered
2026-05-07
Start date
2026-06-01
Completion date
2026-09-21
Last updated
2026-05-11

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

Conditions

None listed

Brief summary

This study aims to evaluate whether a nurse-led clinic using electronic symptom monitoring can improve support for women starting adjuvant endocrine therapy after early breast cancer treatment. Who is it for? This study is for women aged 18 years or older diagnosed with primary early-stage hormone receptor–positive breast cancer, prescribed and consenting to commence adjuvant endocrine therapy (AET) and able to read and understand English. Study details Participants will complete regular online symptom assessments during the first 12 weeks of treatment which will be reviewed by cancer care nurse specialists. All participants will be included in the study if they meet the eligibility criteria and consent. There are no tests required for the study however depending on specialist nurse review of reported symptoms and side effects participants may be referred for tests as part of their disease management. It is hoped this nurse-led clinic using electronic symptom monitoring can improve symptom management and treatment adherence while reducing the need for routine oncology follow-up visits.

Interventions

The intervention in this study is a new nurse-led clinic (NLC) model of care designed to proactively monitor and manage symptoms for patients commencing adjuvant endocrine therapy (AET) for early, hormone receptor-positive breast cancer. This model replaces the current standard practice in Illawarra Shoalhaven Local Health District (ISLHD), where patients typically wait 6–8 weeks for a routine medical oncology follow-up appointment without formal interval monitoring. The NLC intervention consis

The intervention in this study is a new nurse-led clinic (NLC) model of care designed to proactively monitor and manage symptoms for patients commencing adjuvant endocrine therapy (AET) for early, hormone receptor-positive breast cancer. This model replaces the current standard practice in Illawarra Shoalhaven Local Health District (ISLHD), where patients typically wait 6–8 weeks for a routine medical oncology follow-up appointment without formal interval monitoring. The NLC intervention consists of the following components and processes: • Electronic Symptom Monitoring: Patients complete electronic patient-reported outcome (ePRO) symptom assessments at baseline (defined as prior to commencement of AET), and at 2, 4, 8, and 12 weeks following treatment initiation. The ePRO tool incorporates validated measures, including the Functional Assessment of Cancer Therapy – Endocrine Subscale (FACT-ES) and the Australasian Menopause Society Symptom Score Card, and is administered via a secure online platform. • Proactive Nurse Review: A breast cancer care nurse reviews each ePRO submission within 72 hours of completion. • Targeted Clinical Support: Clinical support is delivered primarily via telephone or email, with face-to-face consultation arranged if clinically indicated. Following each ePRO review, patients may receive nurse-initiated contact where symptoms warrant intervention. The frequency and duration of contact are individualised based on patient need, typically ranging from brief (5–10 minute) telephone consultations to longer discussions (up to approximately 30 minutes) when more complex symptom management is required. Contact generally occurs at each assessment timepoint where symptoms are identified, rather than at fixed intervals. Support strategies provided by the nurse may include: Education and advice: Patients may receive a combination of written and digital resources, including patient information sheets, website links, and webinars/podcasts. These materials are not developed specifically for this study but are sourced from established organisations such as Breast Cancer Network Australia and the Australasian Menopause Society, as well as standard clinical education resources used within ISLHD. Symptom management guidance: Tailored advice is provided based on reported symptoms (e.g., management of menopausal symptoms, musculoskeletal pain, or sexual dysfunction). Facilitation of referrals: The nurse may coordinate referrals to internal ISLHD services (e.g., Menopause Service, psychology, lymphoedema physiotherapy) by initiating referral processes, liaising with relevant departments, and assisting with appointment coordination where required. Referrals to external services (e.g., general practitioners for chronic disease management plans) may also be recommended, with guidance provided to the patient on how to access these services. Escalation of care: Where symptoms fall outside the nurse’s scope of practice or are clinically concerning, the nurse may facilitate earlier review by a medical oncologist. • Adherence to the intervention is monitored through: Completion rates of scheduled ePRO assessments recorded within REDCap. Documentation of nurse review and patient contact within the platform. Nurse-completed activity time logs capturing all intervention-related activities (e.g., review time, patient contact, referrals).

Sponsors

Illawarra Shoalhaven Local Health District
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

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

Inclusion criteria

Participants will be recruited into three cohorts: breast cancer care nurses, a prospective patient intervention cohort, and a retrospective historical control cohort. Prospective patient cohort (intervention group): Aged 18 years or older. Diagnosed with primary early-stage hormone receptor–positive breast cancer. Prescribed and consenting to commence AET. Able to read and understand English. Provide written informed consent to participate. Retrospective patient cohort (historical control cohort): Aged 18 years or older. Diagnosed with primary early-stage hormone receptor–positive breast cancer. Commenced AET within the 12 months preceding study commencement. Have complete medical records sufficient to determine treatment adherence and healthcare utilisation during the first 12 weeks of therapy. Nurse cohort: Registered breast cancer care nurse employed within Illawarra Shoalhaven Local Health District (ISLHD). Currently involved in monitoring patients with early hormone receptor–positive breast cancer.

Exclusion criteria

Prospective patient cohort (intervention group): Hormone receptor–negative breast cancer. Advanced or metastatic breast cancer. Prescribed combined treatment with adjuvant endocrine therapy and a CDK4/6 inhibitor. Retrospective patient cohort (historical control group): Hormone receptor–negative breast cancer. Advanced or metastatic breast cancer. Prescribed combined treatment with adjuvant endocrine therapy and a CDK4/6 inhibitor. Previously completed AET electronic patient-reported outcome (ePRO) assessments as part of quality improvement testing. Medical records lacking sufficient information to determine adherence or healthcare utilisation outcomes. Nurse cohort: Breast care nurses exclusively managing patients with advanced or metastatic breast cancer.

Outcome results

None listed

Source: ANZCTR · Data processed: May 16, 2026