A Randomised Phase II Trial to Examine Feasibility of Standardised, Early Palliative (STEP) Care for Patients with Advanced Cancer and their Families

• Register: ANZCTR
• Last refreshed on: 15 July 2019
• Main ID: ACTRN12617000534381
• Date of registration: 12/04/2017
• Prospective Registration: No
• Primary sponsor: Prof Jennifer Philip
• Public title: A Randomised Phase II Trial to Examine Feasibility of Standardised, Early Palliative (STEP) Care for Patients with Advanced Cancer and their Families
• Scientific title: A Randomised Phase II Trial to Examine Feasibility of Standardised, Early Palliative (STEP) Care for Patients with Advanced Cancer and their Families
• Date of first enrolment: 04/04/2017
• Target sample size: 120
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12617000534381.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Prof Jennifer Philip

• Name: Prof Jennifer Philip

Key inclusion & exclusion criteria

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




Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Breast

Cancer - Brain

Breast Cancer;Prostate Cancer;High-grade glioma;
Breast Cancer
Prostate Cancer
High-grade glioma

Cancer - Prostate

Intervention(s)

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.

Primary Outcome(s)

Feasibility: at least 60% of enrolled participants progressing to study completion [T3: 12 weeks after baseline]

Feasibility: study enrolment of 120 patients across study sites in 24 months[Study Close: 24 months]

Secondary Outcome(s)

Patients: overall survival[Date of death]

Carer experiences of care (Qualitative interview)[T5: 12 weeks after patient death]

Carer Mood (stress, anxiety, depression) (DASS-21)[T3: 12 weeks after baseline]

Carer Preparedness to care (PCS)[T3 (12 weeks after baseline)]

Patient performance status (AKPS)[T3: (12 weeks after baseline)]

Patients: quality-adjusted survival (QLU-C10U)[quality of life measures (QLU-C10U) and survival at T4 (24 weeks post baseline)]

Incremental cost effectiveness (data linkage to MBS/PBS records)[Study close]

Patient Quality of life at the end of life (QUAL-E)
[T3: 12 weeks after baseline]

Carer Satisfaction with Care (FAMCARE-2)[T5: 12 weeks after patient death]

Patient Health-related quality of life/ symptom impact (QLQ-C30)[T3: 12 weeks after baseline]

Quality of end of life care in the last month of life (Medical record review)
- Chemotherapy use
- >1 ED visit
- >1 acute hospital admission
- Total length of stay > 14 days
- Intensive care admission
- Place of death
[Following death]

Carer Quality of life (CQOL-C)[T3: 12 weeks after baseline]

Patient Mood (stress, anxiety, depression) (DASS-21)[T3: 12 weeks after baseline]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Victorian Cancer Agency

Ethics review

Status: Approved
Approval date:
Contact:

St Vincent's Human Research Ethics Committee