Patient-needs-based multi-professional delivery of Palliative Interventions by oncologists’ and oncology nurses: a randomized Phase II trial

Automatically Closed · 2018 until 2018

Clinical Studies
Multicentric, KSSG as main centre
Automatically Closed
Start Date
End Date
Brief description/objective

Background: Evidence is emerging that early specialist palliative care (SPC) is effective in several defined clinical settings and that it consists of a variety of definable palliative interventions (PCI). PCI encompass pharmacological, procedural, educational, coordinative and counselling interventions. Prior research has suggested that SPC encompasses seven “key”-PCI: addressing illness understanding, symptom management, support in decision making, network planning, family support, end-of-life preparation, and addressing spiritual issues. The applicability and relevance of each PCI is supported by scientific and clinical evidence. Oncology professionals, namely oncologists (ONC) and oncology nurses (ON), also deliver, supported by curricula and guidelines, to a variable but largely unknown degree PCI as part of routine care (basic PC). In clinical practice, patient unmet needs for PCI are a reality, as recently documented in the Cantonal Hospital of St.Gallen applying the patient-centred NEKPI (Needs for Key PCI) tool, where high unmet needs for PCI were associated with depression, suggesting clinical relevance. To respond to unmet patient needs for PCI in routine oncology, clinical practice tools are needed to raise both ONC and ON awareness for patient needs and to support delivery of modular PCI by both ONC and ON applying their core competencies. Aim: To explore patterns of patient-need based delivery of PCI by ONC and ON, its safety, and preliminary effectiveness in routine oncology for patients with advanced, incurable cancer. Hypothesis: The patient-need-based delivery of modular PCI by ONC and ON will result in a 5 point decrease in overall IPOS (Integrated Palliative Outcome) score after 12 weeks and is safe defined as <5% severe adverse events judged by ONC and ON. Design: Prospective randomized controlled phase II trial. Setting: Patients with advanced, incurable cancer treated by outpatient anticancer treatments. Methods: Patients with advanced, incurable cancer who have by ONC predefined limited anticancer treatment options are eligible and screened from oncology outpatient clinics. After informed consent patients are randomized to intervention or control by using sealed envelopes. The intervention consists of a Needs-for-PCI Monitoring Patient Booklet, instructed how to complete and reinforced 3-weekly by a study nurse. The Booklet has to signed by both ONC and ON at each outpatient visit, who may deliver needs-tailored PCI by using the suitable of 14 pragmatic PCI checklists. The control group will after 12 weeks offered to get the intervention. Study-related investigations are planned approx. 3-weekly at routine clinic visits until week 12: - All patients will be assessed for IPOS, NEKPI and recall of delivered PCI by ONC or ON - Nursing and medical documentation are reviewed for documentation of delivered PCI - Oncology professionals are surveyed for adverse events related to NEKPI or delivered PCI - The trial preparation phase includes consensual finalisation of the 14 PCI checklists and teaching of all oncology professionals using standard institutional educational sources. Planned analysis & sample size Primary endpoint is IPOS sum score at week 12, for 80% power with p<0.05 (dependent t-test). 76 patients are required, adding 20% attrition rate, 91 patients are recruited. Secondary endpoints are a) safety observations in the intervention arm, b) perceived unmet needs (gap of need for and recalled delivery of PCI by NEKPI) in intervention and control group, c) number and type of and involved professional(s) in delivered PCI in both groups. Exploratory endpoints are a) ON specific PCI-related patient advise on patient self-management and on reasons when to contact ONC or ON, b) association of perceived unmet need by NEKPI and actually delivered PCI and c) clinical triggers leading to delivery of PCI. Relevance of project
The study will provide understanding a) of the importance of components of the intervention to achieve outcomes (IPOS, unmet needs), b) how collaboration of ONC and ON including specialist palliative care occurs in delivering PCI, c) clinical data on routine delivery of PCI by ONC and ON in the control group, and d) experiences of nurses on PCI-specific patient empowerment for self-management. The refined intervention may lead to a phase III trial.