Evidence map›Paper›PMID 32404096›Full record

ArticleBMC cancer2020

Rehabilitation strategies following oesophagogastric and Hepatopancreaticobiliary cancer (ReStOre II): a protocol for a randomized controlled trial.

Linda O'Neill, Emer Guinan, Suzanne Doyle, Deirdre Connolly, Jacintha O'Sullivan, Annemarie Bennett, Grainne Sheill, Ricardo Segurado, Peter Knapp, Ciaran Fairman and 5 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03958019 (Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing 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.

NCT03958019 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (RESTORE II) - A Randomised Controlled Trial

TypeinterventionalSponsorUniversity of Dublin, Trinity CollegeRan2022 to 2024Enrolled120ConditionsOesophageal Cancer, Gastric Cancer, Liver Cancer, Pancreatic CancerArmsRESTORE II Program
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Feasibility of a comprehensive supervised exercise program during and after treatment of head and neck cancer: a mixed-methods study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Trial
  5. Physical activity and exercise in liver cancer.Liver research (Beijing, China) · 2024
    Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. 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

15 authors.

Linda O'NeillDiscipline of Physiotherapy, School of Medicine, Trinity College, the University of Dublin, Dublin, Ireland. oneilll8@tcd.ie.ORCID http://orcid.org/0000-0002-0109-9650
Emer GuinanSchool of Medicine, Trinity College, the University of Dublin, Dublin, Ireland.
Suzanne DoyleSchool of Biological and Health Sciences, Technological University Dublin, Dublin, Ireland.
Deirdre ConnollyDiscipline of Occupational Therapy, School of Medicine, Trinity College, the University of Dublin, Dublin, Ireland.
Jacintha O'SullivanDepartment of Surgery, Trinity Translational Medicine Institute, Trinity College, the University of Dublin and St. James's Hospital, Dublin, Ireland.
Annemarie BennettDepartment of Clinical Medicine, Trinity College, the University of Dublin, Dublin, Ireland.
Grainne SheillDiscipline of Physiotherapy, School of Medicine, Trinity College, the University of Dublin, Dublin, Ireland.
Ricardo SeguradoCentre for Support and Training in Analysis and Research, and School of Public Health, Physiotherapy and Sports Sciences, University College Dublin, Dublin, Ireland.
Peter KnappDepartment of Health Sciences and the Hull York Medical School, University of York, York, UK.
Ciaran FairmanExercise Medicine Research Institute, School of Medical and Health Sciences, Edith Cowan University, Joondalup, Australia.
Charles NormandCentre for Health Policy and Management, Trinity College, the University of Dublin, Dublin, Ireland.
Justin GeogheganDepartment of Surgery, St Vincent's University Hospital, Dublin, Ireland.
Kevin ConlonDepartment of Surgery, St Vincent's University Hospital, Dublin, Ireland.
John V ReynoldsDepartment of Surgery, Trinity Translational Medicine Institute, Trinity College, the University of Dublin and St. James's Hospital, Dublin, Ireland.
Juliette HusseyDiscipline of Physiotherapy, School of Medicine, Trinity College, the University of Dublin, Dublin, Ireland.

Funding

Health Research Board HRB-DIFA-2018-009Wellcome Trust
6 · The paper itself

Abstract

backgroundCurative treatment for upper gastrointestinal (UGI) and hepatopancreaticobiliary (HPB) cancers, involves complex surgical resection often in combination with neoadjuvant/adjuvant chemo/chemoradiotherapy. With advancing survival rates, there is an emergent cohort of UGI and HPB cancer survivors with physical and nutritional deficits, resultant from both the cancer and its treatments. Therefore, rehabilitation to counteract these impairments is required to maximise health related quality of life (HRQOL) in survivorship. The initial feasibility of a multidisciplinary rehabilitation programme for UGI survivors was established in the Rehabilitation Strategies following Oesophago-gastric Cancer (ReStOre) feasibility study and pilot randomised controlled trial (RCT). ReStOre II will now further investigate the efficacy of that programme as it applies to a wider cohort of UGI and HPB cancer survivors, namely survivors of cancer of the oesophagus, stomach, pancreas, and liver.

methodsThe ReStOre II RCT will compare a 12-week multidisciplinary rehabilitation programme of supervised and self-managed exercise, dietary counselling, and education to standard survivorship care in a cohort of UGI and HPB cancer survivors who are > 3-months post-oesophagectomy/ gastrectomy/ pancreaticoduodenectomy, or major liver resection. One hundred twenty participants (60 per study arm) will be recruited to establish a mean increase in the primary outcome (cardiorespiratory fitness) of 3.5 ml/min/kg with 90% power, 5% significance allowing for 20% drop out. Study outcomes of physical function, body composition, nutritional status, HRQOL, and fatigue will be measured at baseline (T0), post-intervention (T1), and 3-months follow-up (T2). At 1-year follow-up (T3), HRQOL alone will be measured. The impact of ReStOre II on well-being will be examined qualitatively with focus groups/interviews (T1, T2). Bio-samples will be collected from T0-T2 to establish a national UGI and HPB cancer survivorship biobank. The cost effectiveness of ReStOre II will also be analysed. DISCUSSION: This RCT will investigate the efficacy of a 12-week multidisciplinary rehabilitation programme for survivors of UGI and HPB cancer compared to standard survivorship care. If effective, ReStOre II will provide an exemplar model of rehabilitation for UGI and HPB cancer survivors.

trial registrationThe study is registered with ClinicalTrials.gov, registration number: NCT03958019, date registered: 21/05/2019.

Indexed as

Bile Duct NeoplasmsEsophageal NeoplasmsEsophagectomyEsophagogastric JunctionHumansLiver NeoplasmsPancreatic NeoplasmsPrognosisRandomized Controlled Trials as TopicResearch DesignStomach NeoplasmsDietExerciseHepatobiliary cancerLiver cancerMultidisciplinary rehabilitationOesophagogastric cancerPancreatic cancer

Identifiers

PMID32404096
PMCPMC7222585

What OpenQuestion holds

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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.