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

Abstract

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.

ReStOre@Home: Feasibility study of a virtually delivered 12-week multidisciplinary rehabilitation programme for survivors of upper gastrointestinal (UGI) cancer - study protocol

“…Hand grip strength (HGS) provides a measure of hand and forearm strength and is found to correlate well with overall muscle strength and physical function 27 . The 1-RM leg-press test will be performed as per the ReStOre II trial protocol 8 . Physical activity levels will be measured by the Godin Leisure-Time Exercise Questionnaire, a validated tool for determining physical activity levels in cancer survivors 28 .…”

“…The ReStOre@Home intervention will be delivered virtually through a video-conferencing platform and will follow a modified version of our established protocol for the ReStOre II RCT 8 , the feasibility of which has been previously determined 4,6 . The ReStOre@Home programme comprises of three elements: exercise training, individualised dietetic counselling, and multidisciplinary education.…”

ReStOre@Home: Feasibility study of a virtually delivered 12-week multidisciplinary rehabilitation programme for survivors of upper gastrointestinal (UGI) cancer - study protocol

“…The ReStOre@Home intervention will be delivered virtually through a video-conferencing platform and will follow a modified version of our established protocol for the ReStOre II RCT 8 , the feasibility of which has been previously determined 4 , 6 . The ReStOre@Home programme comprises of three elements: exercise training, individualised dietetic counselling, and multidisciplinary education.…”

“…The exercise component will consist of a 12-week programme of aerobic and resistance programme. Unsupervised aerobic exercise in the form of walking will be prescribed as per the F.I.T.T (Frequency, intensity, type and time) principles outlined in the ReStOre II protocol 8 , commencing at a low intensity (40–45% heart rate reserve (HRR)) and progressing to a moderate-vigorous intensity (65–85% HRR) 8 . During the ReStOre@Home Programme all walking sessions will be monitored by the participant’s Polar Heart Rate Monitor (Polar M200) which will be provided.…”

“…Thus the ReStOre RCT is the first evidence-based model of rehabilitation in UGI cancer survivorship. The ReStOre II (Rehabilitation Strategies following Oesophagogastric and Hepatopancreaticobiliary Cancer) RCT now plans to further examine the effectiveness of the ReStOre programme by RCT in a larger cohort of upper-gastrointestinal (UGI) cancer survivors 8 . However, due to the coronavirus disease 2019 (COVID-19) pandemic plans to commence recruitment to the ReStOre II RCT have been delayed until public health advice facilitates implementation of such activities.…”