Evidence map›Paper›PMID 38441657›Full record

Trial reportInternational journal of colorectal disease2024

Developing a multivariable prediction model of global health-related quality of life in patients treated for rectal cancer: a prospective study in five countries.

John Andersson, Eva Angenete, Martin Gellerstedt, Eva Haglind

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in International journal of colorectal disease, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00297791 (A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.), 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
–field-weighted citation impact
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.

NCT00297791 phase3completednot on this map

A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.

TypeinterventionalSponsorNova Scotia Health AuthorityRan2004 to 2015Enrolled1,044ConditionsRectal CancerArmssurgery
3 · Its place in the literature

Who cites it

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

  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

4 authors.

John AnderssonDepartment of General and Orthopaedic Surgery, Alingsås Hospital, Alingsås, Sweden.ORCID http://orcid.org/0009-0005-1932-3189
Eva AngeneteDepartment of Surgery, SSORG - Scandinavian Surgical Outcomes Research Group, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.ORCID http://orcid.org/0000-0001-9966-4904
Martin GellerstedtSchool of Health Sciences, University of Skövde, Skövde, Sweden.ORCID http://orcid.org/0000-0002-0575-4309
Eva HaglindDepartment of Surgery, SSORG - Scandinavian Surgical Outcomes Research Group, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. eva.haglind@vgregion.se.ORCID http://orcid.org/0000-0002-1147-5605

Funding

Swedish Cancer Society CAN 2010/593CAN 2013/497; CAN 2016/362; Pj19 0303Swedish state under the agreement between the Swedish government and the county councils, the ALF-agreement ALFGBG-138751; ALFGBG-4307771; ALFGBG-718221; ALFGBG-965245
6 · The paper itself

Abstract

purposeRectal cancer and its treatment have a negative impact on health-related quality of life (HRQoL). If risk factors for sustained low HRQoL could be identified early, ideally before the start of treatment, individualised interventions could be identified and implemented to maintain or improve HRQoL. The study aimed to develop a multivariable prediction model for global HRQoL 12 months after rectal cancer treatment.

methodsWithin COLOR II, a randomised, multicentre, international trial of laparoscopic and open surgery for rectal cancer, a sub-study on HRQoL included 385 patients in 12 hospitals and five countries. The HRQoL study was optional for hospitals in the COLOR II trial. EORTC QLQ-C30 and EORTC QLQ-CR38 were analysed preoperatively and at 1 and 12 months postoperatively. In exploratory analyses, correlations between age, sex, fatigue, pain, ASA classification, complications, and symptoms after surgery to HRQoL were studied. Bivariate initial analyses were followed by multivariate regression models.

resultsPatient characteristics and clinical factors explained 4-10% of the variation in global HRQoL. The patient-reported outcomes from EORTC QLQ-C30 explained 55-65% of the variation in global HRQoL. The predominant predictors were fatigue and pain, which significantly impacted global HRQoL at all time points measured.

conclusionWe found that fatigue and pain were two significant factors associated with posttreatment global HRQoL in patients treated for rectal cancer T1-T3 Nx. Interventions to reduce fatigue and pain could enhance global HRQoL after rectal cancer treatment.

trial registrationThis trial is registered with ClinicalTrials.gov No. NCT00297791.

Indexed as

Quality of LifeRectal NeoplasmsFatigueHumansPainProspective StudiesColorectal cancerEORTC QLQFatiguePainQuality of lifeRisk factors

Identifiers

PMID38441657
PMCPMC10914847

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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.