None listed
Conditions
Brief summary
The purpose of this study is to test the implementation of a care model involving hospital-based medical teams (medical, surgical and radiation oncologists) and GPs for post-treatment follow-up care for early breast cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, and have breast cancer. Study details Participants in this study will be assigned into two groups. One group will receive standard follow-up (hospital-led) 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 hospital cancer specialists for up to 5 years. As part of the study all participants will answer a series of questionnaires every 6 months for 12 months. It is hoped this research will demonstrate the and effectiveness and cost-effectiveness of the new model of care which could influence future breast cancer follow-up care.
Interventions
Six sites across Australia will gain access to IBIS-Survivorship model of care to be rolled out every 4 months. 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. If the site has been randomised to commence the intervention then participants will receive the IBIS-Survivorship model of care: 1 x 30-60 minute face-to-face or telehealth Specialist Cancer Nurse consult with the participant 8+/-2 weeks post-treatment 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 it's components will be monitored using a nurse-led clinic checklist. 1 x 20-30 minute video/telephone case-conference between the Specialist Cancer 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 post-treatment shared-care follow-up appointment schedule. Adherence to the GP case conference and it's components will be monitored using a GP case conference checklist. Up to 11 (depending on how far post-diagnosis 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. 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, 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 Specialist Cancer 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-diagnosis for review, physical examination, and imaging (i.e., annual mammogram). 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
Study design
Eligibility
Inclusion criteria
- Early breast cancer as defined as stage I-III (inclusive of ductal carcinoma in situ (DCIS) and locally advanced breast cancer but no distant metastases) who are: - within ten weeks of completion of adjuvant treatment for early stage breast cancer at a participating site; OR within ten weeks post-surgery if not scheduled for further adjuvant therapy; - Can identify a regular GP; - Ambulatory with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; and - Able to read and understand English. Recurrent or secondary primary breast cancer, comorbidities, other prior cancer diagnoses or Trastuzumab (or biosimilars), neoadjuvant and/or ongoing endocrine therapies are NOT exclusion criteria
Exclusion criteria
- have metastatic (distant) breast cancer; or - the presence of severe mental, cognitive or physical conditions that would limit the patient’s ability to participate at the discretion of treating clinicians