Clinical trial NCT01983956: A Structured Early Palliative Care Intervention for Patients With Advanced Cancer - a Randomized Controlled Trial With a Nested Qualitative Study (SENS Trial)
Official title: A Structured Early Palliative Care Intervention for Patients With Advanced Cancer - a Randomized Controlled Trial With a Nested Qualitative Study (SENS Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Cancer
Keywords: early palliative care
patient empowerment
cancer
assessment
end of life
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
name: Swiss National Science Foundation
First posted: 2013-11-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is assumed that an early palliative care structured by SENS (a systematic, problem-based assessment system) in addition to standard oncology care compared with standard oncology care alone relieves distress in patients with advanced cancer at the end of life.

The primary objective of the trial is to determine the effectiveness of early palliative care intervention, structured by SENS (a systematic, problem-based assessment system) in addition to standard oncology care, compared with standard oncology care alone to relieve distress a) in patients with advanced cancer until death, and b) in caregivers. The secondary objectives are to determine whether the introduction of SENS improves quality of life, prolongs overall survival, ameliorates distress of caregivers, reduces health care costs and medical resource utilization (less aggressive treatment in the last weeks of life).

Detailed description: Background

Intervention (performed by specialist palliative care teams): The structured approach intervention is based on NCCN Practice Guidelines for Palliative Care, part of Gold Standard Framework (GSF) and the WHO definition of Palliative Care. It supports the assessment of areas and complexity of concerns from the patient perspective, determining priorities and structures the support needed. SENS stands for: Symptom-management, instruction for self administration of medication etc. End of life decision-making: explicit definition of own goals and priorities; Network organization including anticipatory planning of emergency situations

Support of the carers: implementation of support systems for the caring family members

The standardized intervention (based on prepared educational tool kit including a patient prompt sheet) is performed by a palliative care physician and nurse collaboratively after randomization and consent. The intervention is undertaken only once (after baseline questionnaire and before first follow-up questionnaire). There is a total of 4 questionnaires in the first 6 months. In addition, patients will receive usual oncology care throughout the study period (see below).

Usual Oncology care (performed by oncological out- and inpatient clinics): Usual care incorporates a routine assessment according to national protocols, which assesses overall symptoms and current complaints from other domains. Participants assigned to usual care may meet with the palliative care service on request according to established practice but without following the SENS approach (subgroup analysis will be performed).

Main eligibility criteria

Patients \>/= 18 years of age who signed informed consent with understanding of the study procedures and the investigational nature of the study with one of the following cancer types:

* Diagnosed within the last 16 weeks
* Metastatic or locally advanced, not amenable to curative treatment, non- small cell lung cancer (NSCLC), or
* Metastatic or locally advanced, not amenable to curative treatment, colorectal cancer, or
* Metastatic or locally advanced, not amenable to curative treatment, prostate cancer, or
* Metastatic or locally advanced, not amenable to curative treatment, breast cancer with visceral and/or brain metastasis, or
* Metastatic or locally advanced, not amenable to curative treatment, bladder/ urothelium cancer, or
* Metastatic or locally advanced, not amenable to curative treatment, pancreatic cancer
* Diagnosis is histologically confirmed
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2

Exclusion criteria

* Presence of delirium or dementia or other reason for lack of ability to give informed consent
* Inability to communicate adequately in German
* Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the study and to formulate his/her own wishes correspondingly
* Patients already receiving care from an inpatient palliative care service

Outcomes Primary outcomes

* Distress over six month as measured with the National Comprehensive Cancer Network (NCCN) Distress thermometer Secondary outcomes
* Quality of life as measured by Functional Assessment of Cancer Therapy - General (FACT-G)
* Palliative Outcome Scale (POS)
* Overall survival
* Location of death
* Health care utilization

Objective

The primary objective of the trial is to determine the effectiveness of early palliative care structured by SENS (a systematic, problem-based assessment system) in addition to standard oncology care compared with standard oncology care alone to relieve distress in patients with advanced cancer at the end of life.

The secondary objectives are to determine whether the introduction of SENS improves quality of life and prolongs overall survival in these patients, reduces health care costs and medical resource utilization.

The primary objective of the nested qualitative study is to identify characteristics and reasons for the added value as well as failure of a compulsory problem-based assessment system (SENS) in advanced cancer patients.

Methods

Design Multicenter, two-arm, parallel-group, randomized-controlled trial with a nested qualitative study (content analysis)

Experimental arm:

Palliative care with a structured approach (SENS model) based on the bio-psycho-social-spiritual model of care. The approach supports the assessment of areas and complexity of concerns from the patient perspective, determines the priority and structures the support needed. The intervention is performed by palliative care physicians and nurses collaboratively.

Control arm: Patients in the usual care group will receive routine oncology care throughout the study.

Eligibility criteria: Inclusion Criteria:

* Diagnosed within the last 16 weeks
* Metastatic or locally advanced, not amenable to curative treatment, non- small cell lung cancer (NSCLC), or
* Metastatic or locally advanced, not amenable to curative treatment, colorectal cancer, or
* Metastatic or locally advanced, not amenable to curative treatment, prostate cancer, or
* Metastatic or locally advanced, not amenable to curative treatment, breast cancer with visceral and/or brain metastasis, or
* Metastatic or locally advanced, not amenable to curative treatment, bladder/ urothelium cancer, or
* Metastatic or locally advanced, not amenable to curative treatment, pancreatic cancer
* Diagnosis is histologically confirmed
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
* At least 18 years of age at the time of enrolment
* Signed informed consent with understanding of the study procedures and the investigational nature of the study

Exclusion Criteria

* Presence of delirium or dementia or other reason for lack of ability to give informed consent
* Inability to communicate adequately in German
* Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the study and to formulate his/her own wishes correspondingly
* Patients already receiving care from an inpatient palliative care service

Primary outcomes:
measure: Distress over six month as measured with the National Comprehensive Cancer Network (NCCN) Distress thermometer
timeFrame: Six months
Secondary outcomes:
measure: Quality of life as measured by Functional Assessment of Cancer Therapy - General (FACT-G)
timeFrame: Six months
measure: Palliative Outcome Scale (POS)
timeFrame: Six months
measure: Overall survival
timeFrame: four years
measure: Location of death
timeFrame: Six months
measure: Health care utilization
timeFrame: Six months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dep. of Haematology, Oncology, Infectiolog, Laboratory Medicine and Spital-pharmacy (DOLS); University Center for Palliative Care, Bern University Hospital, 3010 Bern
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern, Medizinische Onkologie, Schwerpunktabteilung Palliative Care
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen, Palliativzentrum
Study officials:
affiliation: University Hospital Berne; University Center for Palliative Care
name: Steffen Eychmüller, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
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