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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Advanced Cancer

Intervention / Treatment
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* Behavioral: SENS model


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>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<br>* 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.<br>|
| No Intervention: Control arm<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distress over six month as measured with the National Comprehensive Cancer Network (NCCN) Distress thermometer |  | 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) |  | Six months | 
| Palliative Outcome Scale (POS) |  | Six months | 
| Overall survival |  | four years | 
| Location of death |  | Six months | 
| Health care utilization | Measured using the questionnaire of Stanford Patient Education Research Centre. | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early palliative care, patient empowerment, cancer, assessment, end of life