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

Advanced Cancer Clinical Trial

— SENS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01983956
• Other study ID #: 102/13
• Secondary ID: 2401406740_14508
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 23, 2013
• Est. completion date: April 25, 2020

Study information

• Verified date: April 2019
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: April 25, 2020
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Swiss National Science Foundation, University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (6)

Abstracts of the ninth annual meeting of the Japanese Society of Biorheology. Ehime, Japan, 13-15 June 1986. Biorheology. 1986;23(5):513-47. — View Citation

Hawkes AL, Hughes KL, Hutchison SD, Chambers SK. Feasibility of brief psychological distress screening by a community-based telephone helpline for cancer patients and carers. BMC Cancer. 2010 Jan 12;10:14. doi: 10.1186/1471-2407-10-14. — View Citation

Temel JS, Greer JA, Admane S, Gallagher ER, Jackson VA, Lynch TJ, Lennes IT, Dahlin CM, Pirl WF. Longitudinal perceptions of prognosis and goals of therapy in patients with metastatic non-small-cell lung cancer: results of a randomized study of early palliative care. J Clin Oncol. 2011 Jun 10;29(17):2319-26. doi: 10.1200/JCO.2010.32.4459. Epub 2011 May 9. — View Citation

Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678. — View Citation

Zhang B, Wright AA, Huskamp HA, Nilsson ME, Maciejewski ML, Earle CC, Block SD, Maciejewski PK, Prigerson HG. Health care costs in the last week of life: associations with end-of-life conversations. Arch Intern Med. 2009 Mar 9;169(5):480-8. doi: 10.1001/archinternmed.2008.587. — View Citation

Zmorski T, Fischer-Cornelssen KA. [Clinical experiences with the new-generation anxiolytic agent cloxazolam--a double-blind study]. Schweiz Rundsch Med Prax. 1985 Jul 2;74(27):728-34. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distress over six month as measured with the National Comprehensive Cancer Network (NCCN) Distress thermometer		Six months
Secondary	Quality of life as measured by Functional Assessment of Cancer Therapy - General (FACT-G)		Six months
Secondary	Palliative Outcome Scale (POS)		Six months
Secondary	Overall survival		four years
Secondary	Location of death		Six months
Secondary	Health care utilization	Measured using the questionnaire of Stanford Patient Education Research Centre.	Six months