Journal Article

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

O’Neill, Linda, Normand, Charles, Connolly, Deirdre, Guinan, Emer, O’Sullivan, Jacintha, Knapp, Peter, Bennett, Annemarie, Geoghegan, Justin, Hussey, Juliette, Segurado, Ricardo, Fairman, Ciaran, Sheill, Grainne, Conlon, Kevin, Reynolds, John V., Doyle, Suzanne

2020

Overview

Background Curative 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. Methods The 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 registration The study is registered with ClinicalTrials.gov , registration number: NCT03958019 , date registered: 21/05/2019

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Analysis / Bile Duct Neoplasms - rehabilitation / Bile Duct Neoplasms - surgery / Biomedical and Life Sciences / Biomedicine / Body composition / cancer burden and supportive therapy / Cancer Research / Cancer therapies / Cancer treatment / Care and treatment / Chemoradiotherapy / Chemotherapy / Esophageal cancer / Esophageal Neoplasms - rehabilitation / Esophageal Neoplasms - surgery / Esophagectomy / Esophagogastric Junction - surgery / Esophagus / Exercise / Exercise intensity / Feasibility studies / Gastrectomy / Gastric cancer / Health Promotion and Disease Prevention / Heart rate / Hepatobiliary cancer / Hospitals / Humans / Intervention / Liver / Liver cancer / Liver Neoplasms - rehabilitation / Liver Neoplasms - surgery / Medical research / Medicine/Public Health / Morbidity / Multidisciplinary rehabilitation / Nutritional status / Objectives / Oesophagogastric cancer / Oncology / Pancreas / Pancreatic cancer / Pancreatic Neoplasms - rehabilitation / Pancreatic Neoplasms - surgery / Pancreaticoduodenectomy / Participation / Physical fitness / Physiological aspects / Prognosis / Quality of life / Radiation therapy / Randomized Controlled Trials as Topic / Rehabilitation / Research Design / Stomach cancer / Stomach Neoplasms - rehabilitation / Stomach Neoplasms - surgery / Strength training / Study Protocol / Surgery / Surgical Oncology / Survival / Survivorship / Well being