Advanced CancerSENSNCT01983956
A Structured Early Palliative Care Intervention for Patients With Advanced Cancer - a Randomized Controlled Trial With a Nested Qualitative Study (SENS Trial)
A study testing SENS model in people with Advanced Cancer, run by Insel Gruppe AG, University Hospital Bern at 3 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- SENS model
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 23 Dec 2013to 25 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Dep. of Haematology, Oncology, Infectiolog, Laboratory Medicine and Spital-pharmacy (DOLS); University Center for Palliative Care, Bern University Hospital, 3010 Bern
Bern, 3010
Kantonsspital Luzern, Medizinische Onkologie, Schwerpunktabteilung Palliative Care
Lucerne, 6000 Luzern 16
Kantonsspital St. Gallen, Palliativzentrum
Sankt Gallen, 9000
About this study
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).
Read the detailed 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.
- Conditions
- Advanced Cancer
- Being tested
- SENS model
- Keywords
- early palliative care, patient empowerment, cancer, assessment, end of life
- Medical subject headings
- Patient Participation, Neoplasms, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENS modelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress over six month as measured with the National Comprehensive Cancer Network (NCCN) Distress thermometer
Measured: Six months
Secondary outcomes (5)
Quality of life as measured by Functional Assessment of Cancer Therapy - General (FACT-G)
Measured: Six months
Palliative Outcome Scale (POS)
Measured: Six months
Overall survival
Measured: four years
Location of death
Measured: Six months
Health care utilization
Measured using the questionnaire of Stanford Patient Education Research Centre.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study start23 Dec 2013
- Primary completion31 Oct 2018
- Study completion25 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern, Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Steffen Eychmüller, Prof. Dr. med., Principal investigator, University Hospital Berne; University Center for Palliative Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983956
- Sponsor's protocol ID
- 102/13
- Other IDs
- 2401, 406740_145088/1
- Acronym
- SENS
- Status last verified
- Apr 2019
- First submitted
- 5 Nov 2013
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 3651574Temel 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.
PubMed 21555700Temel 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.
PubMed 20818875Zhang 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.
PubMed 19273778Zmorski 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.
PubMed 2862687Hawkes 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.
PubMed 20067645Maessen 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.
PubMed 38579309Eychmuller 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.
PubMed 33908288Fliedner 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.
PubMed 31068119
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Structured Early Palliative Care Intervention for Patients With Advanced Cancer - a Randomized Controlled Trial With a Nested Qualitative Study (SENS Trial)
- ClinicalTrials.gov ID
- NCT01983956
- Acronym / sponsor ID
- SENS / 102/13
- Conditions
- Advanced Cancer
- Keywords
- early palliative care, patient empowerment, cancer, assessment, end of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern, Swiss National Science Foundation
- Study start
- 23 Dec 2013 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 25 Apr 2020 (estimated)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Behavioral: SENS modelThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SENS modelPalliative 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. | Behavioural | Experimental arm |
Primary outcome
Distress over six month as measured with the National Comprehensive Cancer Network (NCCN) Distress thermometer
Time frame: Six months
5 secondary outcomes
Quality of life as measured by Functional Assessment of Cancer Therapy - General (FACT-G)
Time frame: Six months
Palliative Outcome Scale (POS)
Time frame: Six months
Overall survival
Time frame: four years
Location of death
Time frame: Six months
Health care utilization
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Background: PubMed 3651574Abstracts 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.
- Background: PubMed 21555700Temel 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.
- Background: PubMed 20818875Temel 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.
- Background: PubMed 19273778Zhang 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.
- Background: PubMed 2862687Zmorski 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.
- Background: PubMed 20067645Hawkes 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.
- Derived from this study: PubMed 38579309Maessen 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.
- Derived from this study: PubMed 33908288Eychmuller 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.
- Derived from this study: PubMed 31068119Fliedner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffen Eychmüller, Prof. Dr. med. principal investigator
University Hospital Berne; University Center for Palliative Care
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SENS model in people with Advanced Cancer, run by Insel Gruppe AG, University Hospital Bern at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distress over six month as measured with the National Comprehensive Cancer Network (NCCN) Distress thermometer (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01983956, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.