A Structured Early Palliative Care Intervention for Patients With Advanced Cancer - a Randomized Controlled Trial With a Nested Qualitative Study (SENS Trial) (SENS)

April 18, 2019 updated by: University Hospital Inselspital, Berne

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Dep. of Haematology, Oncology, Infectiolog, Laboratory Medicine and Spital-pharmacy (DOLS); University Center for Palliative Care, Bern University Hospital, 3010 Bern
      • Luzern, Switzerland, 6000 Luzern 16
        • Kantonsspital Luzern, Medizinische Onkologie, Schwerpunktabteilung Palliative Care
      • St. Gallen, Switzerland, 9000
        • Kantonsspital St. Gallen, Palliativzentrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental arm
The structured approach intervention with the SENS model is based on the bio-psycho-social-spiritual model of care and the WHO definitions of palliative care as well as the NCCN Practice Guidelines for Palliative Care. It 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. It is utilized as baseline assessment and afterwards integrated in each routine oncology care out-patient and in-patient visit. Depending on the goals it may be applied between routine visits. In addition, patients will receive usual oncology care throughout the study period.
Behavioral: SENS model
Palliative care with a structured approach (SENS model) based on the bio-psycho-social-spiritual model of care, the WHO definitions of palliative care as well as the National Comprehensive Cancer Networks (NCCN) Practice Guidelines for Palliative 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. It is utilized as baseline assessment and afterwards integrated in each routine oncology care out-patient and in-patient visit. Depending on the goals it may be applied between routine visits. In addition, patients will receive usual oncology care throughout the study period.
NO_INTERVENTION: Control arm
Patients in the usual care group will receive routine oncology care throughout the study. This incorporates a routine assessment according to the standard SAKK - protocol which assesses overall symptoms. Patients are not seen by nurses during a routine visit to the outpatient clinic unless they need a blood withdrawal or any intravenous or subcutaneous treatment. Only nursing staff of the palliative care unit is familiar with using the SENS-assessment instrument. Participants assigned to usual care may meet with the palliative care service on request according to established practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Distress over six month as measured with the National Comprehensive Cancer Network (NCCN) Distress thermometer
Time Frame: Six months
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life as measured by Functional Assessment of Cancer Therapy - General (FACT-G)
Time Frame: Six months
Six months
Palliative Outcome Scale (POS)
Time Frame: Six months
Six months
Overall survival
Time Frame: four years
four years
Location of death
Time Frame: Six months
Six months
Health care utilization
Time Frame: Six months
Measured using the questionnaire of Stanford Patient Education Research Centre.
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

Swiss National Science Foundation
University of Bern

Investigators

  • Principal Investigator: Steffen Eychmüller, Prof. Dr. med., University Hospital Berne; University Center for Palliative Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 23, 2013

Primary Completion (ACTUAL)

October 31, 2018

Study Completion (ANTICIPATED)

April 25, 2020

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 13, 2013

First Posted (ESTIMATE)

November 14, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 18, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102/13
  • 2401 (Direktion Lehre und Forschung, Inselspital (study number))
  • 406740_145088/1 (OTHER_GRANT: Schweizerischer Nationalfonds)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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