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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University Hospital Inselspital, Berne
Sponsor:
Collaborators:
University of Bern
Swiss National Science Foundation
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01983956
First received: November 5, 2013
Last updated: September 1, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention
Advanced Cancer
Behavioral: SENS model

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: A Structured Early Palliative Care Intervention for Patients With Advanced Cancer - a Randomized Controlled Trial With a Nested Qualitative Study (SENS Trial)

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Distress over six month as measured with the National Comprehensive Cancer Network (NCCN) Distress thermometer [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life as measured by Functional Assessment of Cancer Therapy - General (FACT-G) [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Palliative Outcome Scale (POS) [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: four years ] [ Designated as safety issue: No ]
  • Location of death [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Health care utilization [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Measured using the questionnaire of Stanford Patient Education Research Centre.


Estimated Enrollment: 150
Study Start Date: December 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-small cell lung cancer (NSCLC) of any stage, or
  • Metastatic and locally advanced colorectal cancer not suitable for surgery (tumour-board decision), or
  • Metastatic prostate cancer, refractory to androgen blockage, or
  • Advanced breast cancer with visceral and/or brain metastasis
  • 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
  • Pregnant or nursing women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01983956

Contacts
Contact: Sibylle J Christen, MSc 0041 31 632 73 85 sibylle.christen@insel.ch

Locations
Switzerland
Dep. of Haematology, Oncology, Infectiolog, Laboratory Medicine and Spital-pharmacy (DOLS); University Center for Palliative Care, Bern University Hospital, 3010 Bern Recruiting
Bern, Switzerland, 3010
Contact: Steffen Eychmueller, Dr    031 632 51 07    steffen.eychmueller@insel.ch   
Contact: Sibylle J Christen, MSc    031 632 73 85    sibylle.christen@insel.ch   
Principal Investigator: Steffen Eychmueller, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Swiss National Science Foundation
Investigators
Principal Investigator: Steffen Eychmüller, MD University Hospital Berne; University Center for Palliative Care
  More Information

Publications:
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01983956     History of Changes
Other Study ID Numbers: 102/13, 2401, 406740_145088/1
Study First Received: November 5, 2013
Last Updated: September 1, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
early palliative care
patient empowerment
cancer
assessment
end of life

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014