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

NCT01983956 | Unknown DMC

• 3 other identifiers: 102/132401406740_145088/1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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).

Conditions

Advanced Cancer

Keywords

early palliative care; patient empowerment; cancer; assessment; end of life

Outcome Measures

Primary Outcomes (1)

• Distress over six month as measured with the National Comprehensive Cancer Network (NCCN) Distress thermometer

  Six months

Secondary Outcomes (5)

• 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

  Six months

Study Arms (2)

Experimental arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

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.

Interventions

SENS model BEHAVIORAL

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.

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator
• Swiss National Science Foundation: collaborator

Study Sites (3)

Dep. of Haematology, Oncology, Infectiolog, Laboratory Medicine and Spital-pharmacy (DOLS); University Center for Palliative Care, Bern University Hospital, 3010 Bern

Bern, 3010, Switzerland

Location

Kantonsspital Luzern, Medizinische Onkologie, Schwerpunktabteilung Palliative Care

Lucerne, 6000 Luzern 16, Switzerland

Location

Kantonsspital St. Gallen, Palliativzentrum

Sankt Gallen, 9000, Switzerland

Location

Related Publications (9)

• Abstracts of the ninth annual meeting of the Japanese Society of Biorheology. Ehime, Japan, 13-15 June 1986. Biorheology. 1986;23(5):513-47. doi: 10.3233/bir-1986-23507. No abstract available.

  PMID: 3651574 BACKGROUND

• 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.

  PMID: 21555700 BACKGROUND

• 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.

  PMID: 20818875 BACKGROUND

• 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.

  PMID: 19273778 BACKGROUND

• 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. No abstract available. German.

  PMID: 2862687 BACKGROUND

• 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.

  PMID: 20067645 BACKGROUND

• Maessen M, Fliedner MC, Gahl B, Maier M, Aebersold DM, Zwahlen S, Eychmuller S. An economic evaluation of an early palliative care intervention among patients with advanced cancer. Swiss Med Wkly. 2024 Feb 16;154:3591. doi: 10.57187/s.3591.

  PMID: 38579309 DERIVED

• Eychmuller S, Zwahlen S, Fliedner MC, Juni P, Aebersold DM, Aujesky D, Fey MF, Maessen M, Trelle S. Single early palliative care intervention added to usual oncology care for patients with advanced cancer: A randomized controlled trial (SENS Trial). Palliat Med. 2021 Jun;35(6):1108-1117. doi: 10.1177/02692163211005340. Epub 2021 Apr 28.

  PMID: 33908288 DERIVED

• Fliedner M, Zambrano S, Schols JM, Bakitas M, Lohrmann C, Halfens RJ, Eychmuller S. An early palliative care intervention can be confronting but reassuring: A qualitative study on the experiences of patients with advanced cancer. Palliat Med. 2019 Jul;33(7):783-792. doi: 10.1177/0269216319847884. Epub 2019 May 9.

  PMID: 31068119 DERIVED

MeSH Terms

Conditions

Patient Participation; Neoplasms; Death

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Steffen Eychmüller, Prof. Dr. med.

  University Hospital Berne; University Center for Palliative Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 14, 2013
• Study Start: December 23, 2013
• Primary Completion: October 31, 2018
• Study Completion: April 25, 2020
• Last Updated: April 19, 2019

Record last verified: 2019-04

Locations

CH (3)