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

Not Applicable

Recruiting

• Conditions: Breast Cancer; Prostate Cancer; High-grade glioma; Cancer - Breast; Cancer - Prostate; Cancer - Brain

• Registration Number: ACTRN12617000534381
• Lead Sponsor: Prof Jennifer Philip

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-12
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility: study enrolment of 120 patients across study sites in 24 months[Study Close: 24 months];Feasibility: at least 60% of enrolled participants progressing to study completion [T3: 12 weeks after baseline]