Clinical trial · Interventional
A Structured Early Palliative Care Intervention for Patients With Advanced Cancer - a Randomized Controlled Trial With a Nested Qualitative Study (SENS Trial)
NCT01983956CI-TRIAL-00038249SENSunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SENS model | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- 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.
- interventionNames
- Behavioral: SENS model
- type
- NO_INTERVENTION
- label
- Control arm
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (9)
- BACKGROUNDAbstracts 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
- BACKGROUNDTemel 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
- BACKGROUNDTemel 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
- BACKGROUNDZhang 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
- BACKGROUNDZmorski 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
- BACKGROUNDHawkes 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
- DERIVEDMaessen 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.