Evidence map›Paper›PMID 28667207›Full record

Trial reportBMJ open2017

A cluster-randomised, controlled proof-of-concept study to explore the feasibility and effect of a patient-directed intervention on quality of life in patients with advanced soft tissue sarcoma.

Markus Schuler, Stephan Richter, Gerhard Ehninger, Martin Bornhäuser, Leopold Hentschel

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02204111 (Patient Directed Intervention Towards a Multidimensional Recommendation Guideline to Improve the Quality of Life for Patients With Soft Tissue Sarcoma Under Palliative Treatment With Trabectedin), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02204111 completednot on this map

Patient Directed Intervention Towards a Multidimensional Recommendation Guideline to Improve the Quality of Life for Patients With Soft Tissue Sarcoma Under Palliative Treatment With Trabectedin

TypeobservationalSponsorGWT-TUD GmbHRan2014 to 2017Enrolled77ConditionsSoft Tissue SarcomaArmsIntervention
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Markus SchulerDepartment of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.
Stephan RichterDepartment of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.
Gerhard EhningerDepartment of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.
Martin BornhäuserDepartment of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.
Leopold HentschelDepartment of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.
University Hospital Carl Gustav Carus · DEHelios Klinikum Emil von Behring · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEven with evolving and expanding therapeutical options for the treatment of advanced sarcomas over recent years, the balance between efficacy and toxicity still remains a major concern. Moreover, the symptom burden in patients with sarcoma remains high compared with other malignant diseases. It is, therefore, crucial to assess treatment effectiveness not only in terms of disease-related outcomes (eg, overall survival) but also from an individual and patient-centred perspective using the assessment of patient-reported outcomes (PROs). By focusing on PROs as a primary study endpoint, we aim to address key issues for patients with advanced soft tissue sarcoma (STS) undergoing palliative treatment. METHODS AND ANALYSIS: The protocol of the YonLife study describes a multicentre, cluster-randomised, controlled, open-label proof-of-concept study conducted in patients with advanced or metastatic STS treated with trabectedin in seven German hospitals. The primary objective of the study is to exploratively compare overall quality of life between the patients receiving a multidimensional intervention based on individual PROs and those receiving usual supportive treatment. This complex intervention consists of the (1) electronic assessment of PRO, (2) creation of a case vignette based on PRO and clinical data and (3) treatment suggestions based on the discussion of these vignettes in a regularly meeting expert panel. Additionally, the YonLife trial assesses the applicability of a tablet-based assessment of PROs. Patients' and physicians' acceptance and challenges concerning the implementation process will be evaluated. ETHICS AND DISSEMINATION: The YonLife trial has been approved by the Ethics Committee of the University Hospital Dresden as well as by the relevant institutions of each participating centre before patient enrolment. The findings will be reported via relevant peer-reviewed journals as well as through presentation at international conferences. TRIAL REGISTRATION NUMBER: NCT02204111, pre-results.

Indexed as

Palliative CarePatient Reported Outcome MeasuresQuality of LifeAdultAntineoplastic Agents, AlkylatingComputers, HandheldDioxolesFeasibility StudiesFemaleHumansMalePatient SatisfactionProof of Concept StudySarcomaSeverity of Illness IndexTetrahydroisoquinolinesAntineoplastic Agents, AlkylatingDioxolesTetrahydroisoquinolinesTrabectedinadult palliative carehealth informaticspatient reported outcomessarcoma

Identifiers

PMID28667207
PMCPMC5734294
OpenAlexW2736256526

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.