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The Wessex Fit-4-Cancer Surgery Trial (WesFit): a protocol for a factorial-design, pragmatic randomised-controlled trial investigating the effects of a multi-modal prehabilitation programme in patients undergoing elective major intra–cavity cancer surgery

2021· preprint· en· W3200439806 on OpenAlexaff
Malcolm West, Andrew Bates, Chloe Grimmett, Cait Allen, Richard Green, Lesley Hawkins, Helen Moyses, Samantha Leggett, Denny Levett, Sally Rickard, Judit Varkonyi-Sepp, Fran Williams, Stephen A. Wootton, Matthew Hayes, Micheal P W Grocott, Sandy Jack

Bibliographic record

VenueF1000Research · 2021
Typepreprint
Languageen
FieldMedicine
TopicCardiac, Anesthesia and Surgical Outcomes
Canadian institutionsMcGill University
FundersUniversity Hospital Southampton NHS Foundation Trust
KeywordsMedicinePrehabilitationPhysical therapyRandomized controlled trialQuality of life (healthcare)Depression (economics)Aerobic exerciseClinical endpointSurgeryNursing

Abstract

fetched live from OpenAlex

<ns4:p> <ns4:bold>Background:</ns4:bold> Surgical resection remains the primary curative treatment for intra-cavity cancer. Low physical fitness and psychological factors such as depression are predictive of post–operative morbidity, mortality and length of hospital stay. Prolonged post-operative morbidity is associated with persistently elevated risk of premature death. We aim to investigate whether a structured, responsive exercise training programme, a psychological support programme or combined exercise and psychological support, delivered between treatment decision and major intra-cavity surgery for cancer, can reduce length of hospital stay, compared with standard care. </ns4:p> <ns4:p> <ns4:bold>Methods:</ns4:bold> WesFit is a pragmatic <ns4:bold>,</ns4:bold> 2x2 factorial-design, multi-centre, randomised-controlled trial, with planned recruitment of N=1560. Participants will be randomised to one of four groups. Group 1 (control) will receive usual pre-operative care, Group 2 (exercise) patients will undergo 2/3 aerobic, high-intensity interval training sessions per week supervised by personal trainers. Group 3 (psychological support) patients are offered 1 session per week at a local cancer support centre. Group 4 will receive both exercise and psychological support. All patients undergo baseline and pre-operative cardiopulmonary exercise testing, complete self-report questionnaires and will be followed up at 30 days, 12 weeks and 12 months post-operatively. Primary outcome is post-operative length-of-stay. Secondary outcomes include disability-adjusted survival at 1-year postoperatively, post-operative morbidity, and health-related quality of life. Exploratory investigations include objectively measured changes in physical fitness assessed by cardiopulmonary exercise test, disease-free and overall mortality at 1-year postoperatively, longer-term physical activity behaviour change, pre-operative radiological tumour regression, pathological tumour regression, pre and post-operative body composition analysis, health economics analysis and nutritional characterisation and its relationship to post-operative outcome. </ns4:p> <ns4:p> <ns4:bold>Conclusions:</ns4:bold> The WesFit trial will be the first randomised controlled study investigating whether an exercise training programme +/- psychological intervention results in improvements in clinical and patient reported outcomes in patients undergoing major inter-cavity resection of cancer. </ns4:p> <ns4:p> <ns4:bold>ClinicalTrials.gov registration:</ns4:bold> NCT03509428 (26/04/2018) </ns4:p>

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Direct model labels (unvalidated)

Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.

Model armCategoriesStudy designConfidence
gemmano category
Domain: not available · Genre: Protocol
About the Canadian research system: no · About a Canadian topic: no
Not applicablelow
gptno category
Domain: not available · Genre: Protocol
About the Canadian research system: no · About a Canadian topic: no
Randomized triallow
models splitAgreement compares identical category sets and study designs across arms.

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.016
metaresearch head score (Gemma)0.135
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Meta-epidemiology (narrow)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Protocol · Consensus signal: none
Teacher disagreement score0.312
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0160.135
Meta-epidemiology (narrow)0.0010.000
Meta-epidemiology (broad)0.0040.002
Bibliometrics0.0000.001
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0010.002
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.081
GPT teacher head0.401
Teacher spread0.320 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Labeled directly by 2 models reading the full record.

The models applied no category: nothing in the taxonomy fit this work.

The models disagree on parts of this classification; every voice is preserved in the section at the end of the page.

Study designNot applicable · Randomized trial
Domainnot available
GenreProtocol

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations20
Published2021
Admission routes1
Has abstractyes

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