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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) (SENS)

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ClinicalTrials.gov Identifier: NCT01983956
Recruitment Status : Unknown
Verified April 2019 by University Hospital Inselspital, Berne.
Recruitment status was:  Active, not recruiting
First Posted : November 14, 2013
Last Update Posted : April 19, 2019
Sponsor:
Collaborators:
University of Bern
Swiss National Science Foundation
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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).


Condition or disease Intervention/treatment Phase
Advanced Cancer Behavioral: SENS model Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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)
Actual Study Start Date : December 23, 2013
Actual Primary Completion Date : October 31, 2018
Estimated Study Completion Date : April 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Distress over six month as measured with the National Comprehensive Cancer Network (NCCN) Distress thermometer [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Quality of life as measured by Functional Assessment of Cancer Therapy - General (FACT-G) [ Time Frame: Six months ]
  2. Palliative Outcome Scale (POS) [ Time Frame: Six months ]
  3. Overall survival [ Time Frame: four years ]
  4. Location of death [ Time Frame: Six months ]
  5. Health care utilization [ Time Frame: Six months ]
    Measured using the questionnaire of Stanford Patient Education Research Centre.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983956


Locations
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Switzerland
Dep. of Haematology, Oncology, Infectiolog, Laboratory Medicine and Spital-pharmacy (DOLS); University Center for Palliative Care, Bern University Hospital, 3010 Bern
Bern, Switzerland, 3010
Kantonsspital Luzern, Medizinische Onkologie, Schwerpunktabteilung Palliative Care
Luzern, Switzerland, 6000 Luzern 16
Kantonsspital St. Gallen, Palliativzentrum
St. Gallen, Switzerland, 9000
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Swiss National Science Foundation
Investigators
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Principal Investigator: Steffen Eychmüller, Prof. Dr. med. University Hospital Berne; University Center for Palliative Care
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01983956    
Other Study ID Numbers: 102/13
2401 ( Other Identifier: Direktion Lehre und Forschung, Inselspital (study number) )
406740_145088/1 ( Other Grant/Funding Number: Schweizerischer Nationalfonds )
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Keywords provided by University Hospital Inselspital, Berne:
early palliative care
patient empowerment
cancer
assessment
end of life
Additional relevant MeSH terms:
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Neoplasms