Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-06 @ 1:43 PM
Study NCT ID:
NCT01983956
Status:
UNKNOWN
Last Update Posted:
2019-04-19
First Post:
2013-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Structured Early Palliative Care Intervention for Patients With Advanced Cancer - a Randomized Controlled Trial With a Nested Qualitative Study (SENS Trial)
Sponsor:
Insel Gruppe AG, University Hospital Bern
Organization:
Study Overview
Official Title:
A Structured Early Palliative Care Intervention for Patients With Advanced Cancer - a Randomized Controlled Trial With a Nested Qualitative Study (SENS Trial)
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SENS
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).
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: