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NCT01983956: SENS
A Structured Early Palliative Care Intervention for Patients With Advanced Cancer - a Randomized Controlled Trial With a Nested Qualitative Study (SENS Trial)
NA trial testing SENS model in Advanced Cancer in 150 participants. Status unknown.
31 October 2018
Quick facts
| Lead sponsor | Insel Gruppe AG, University Hospital Bern |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 150 |
| Start date | 23 December 2013 |
| Primary completion | 31 October 2018 |
| Estimated completion | 25 April 2020 |
| Sites | 3 locations across Switzerland |
Drugs / interventions tested
- SENS model
Conditions studied
- Advanced Cancer — all drugs for Advanced Cancer →
Sponsor
Insel Gruppe AG, University Hospital Bern
Who can join
18 and older, any sex, with Advanced Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Early palliative care for adults with advanced cancer.
Haun MW, Estel S, Rücker G, Friederich HC, et al · · 2017 · cited 369× · PMID 28603881 · DOI 10.1002/14651858.cd011129.pub2 -
The effectiveness and cost-effectiveness of hospital-based specialist palliative care for adults with advanced illness and their caregivers.
Bajwah S, Oluyase AO, Yi D, Gao W, et al · · 2020 · cited 133× · PMID 32996586 · DOI 10.1002/14651858.cd012780.pub2 -
An early palliative care intervention can be confronting but reassuring: A qualitative study on the experiences of patients with advanced cancer.
Fliedner M, Zambrano S, Schols JM, Bakitas M, et al · · 2019 · cited 31× · PMID 31068119 · DOI 10.1177/0269216319847884 -
Single early palliative care intervention added to usual oncology care for patients with advanced cancer: A randomized controlled trial (SENS Trial).
Eychmüller S, Zwahlen S, Fliedner MC, Jüni P, et al · · 2021 · cited 22× · PMID 33908288 · DOI 10.1177/02692163211005340 -
Development and Use of the 'SENS'-Structure to Proactively Identify Care Needs in Early Palliative Care-An Innovative Approach.
Fliedner MC, Mitchell G, Bueche D, Mettler M, et al · · 2019 · cited 6× · PMID 30791565 · DOI 10.3390/healthcare7010032 -
An economic evaluation of an early palliative care intervention among patients with advanced cancer.
Maessen M, Fliedner MC, Gahl B, Maier M, et al · · 2024 · PMID 38579309 · DOI 10.57187/s.3591
Verify or expand the search:
- PubMed search for NCT01983956
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01983956 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Insel Gruppe AG, University Hospital Bern
- Last refreshed: 19 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01983956.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing