None listed
Conditions
Brief summary
The primary purpose of this trial is to evaluate the feasibility of implementing standardised early palliative (STEP) care for advanced breast, prostate and brain cancer patients. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with prostate cancer with metastases, breast cancer with at least one visceral metastasis or grade IV brain tumour/glioblastoma with recurrent disease or no cancer treatment prescribed, and their nominated carer. You must have been admitted to hospital for a stay lasting more than one day in the previous two weeks. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either standard care or to receive the STEP care intervention in addition to standard care. Participants allocated to the STEP care intervention will receive palliative care consultations (with their carer) at least once per month for three months. If the treating doctor/nurse determines that further palliative care would be beneficial then another three months of consultations may be provided. The palliative care is tailored to the needs of the person and their carer, but will include review and management of any symptoms of concern, referral for additional supports as required, review of informational needs, addressing illness understanding and discussion of prognosis, assistance with care planning, case conference with the person's GP. Researchers will monitor whether the implementation of this program, and whether recruitment into this trial are feasible, as well as asking all participants to complete a number of questionnaires to determine whether the STEP care intervention benefits patient and carer outcomes such quality of life, mood, and survival and reduces time spent in hospital. It is hoped that the results of this pilot trial will inform a future large scale trial to evaluate whether standardised early palliative care is beneficial for advanced cancer patients and their carers.
Interventions
Intervention: Usual oncology care + STEP Care - standardized early palliative care introduced at key transition points in the cancer illness trajectory. The specific transition points for each cancer are:
- Breast: any overnight/multiday inpatient hospital admission with at least one visceral metastasis
- Prostate cancer: any overnight/multiday inpatient hospital admission with any metastasis
- High-grade glioma: any hospital presentation (inpatient or outpatient) with recurrence of grade IV di
Intervention: Usual oncology care + STEP Care - standardized early palliative care introduced at key transition points in the cancer illness trajectory. The specific transition points for each cancer are: - Breast: any overnight/multiday inpatient hospital admission with at least one visceral metastasis - Prostate cancer: any overnight/multiday inpatient hospital admission with any metastasis - High-grade glioma: any hospital presentation (inpatient or outpatient) with recurrence of grade IV disease STEP Care involves palliative care consultation within 14 days of the transition point, with follow-up occurring at minimum monthly for 3 months +/- an additional 3 month bolster as needed (determined by the treating palliative care specialist in consultation with patient and their caregiver). STEP Care is delivered by specialist palliative care consultants, or certified nurse practitioners/ clinical nurse specialists. The care provided will be personalized based upon patient and caregiver need, including review of: symptoms, psychological distress, additional community supports required, informational needs, illness understanding, discussion of prognosis, preferences for care, advance care planning, GP case conference. STEP Care is provided face-to-face upfront, with follow-up either face-to-face or by telephone as needed. Caregivers are invited to participate in consultations. All STEP Care consultations are audio-recorded for auditing, and cross-checked against standardised documentation regarding the consultations completed by treating palliative care specialist.
Sponsors
Prof Jennifer Philip
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients: 1) Diagnosis of: a) Prostate cancer with any metastases b) Breast cancer with at least one visceral metastasis c) Grade IV brain tumour / GBM – recurrent disease or no cancer treatment prescribed 2) Within 2 weeks of multi-day admission 3) Able to provide informed consent/ comply with study procedures. Caregiver: 1) Nominated by eligible patient as a person involved in their care. 2) Able to provide informed consent/ comply with study procedures.
Exclusion criteria
Patients: - Outside 2 weeks of defined transition point - Previous palliative care referral - Needs imminent palliative care referral - Non-English speaking/ not able to complete study measures - Cognitive issues/ not able to complete informed consent Caregivers: - Non-English speaking/ not able to complete study measures
Outcome results
None listed