Curative treatment for upper gastrointestinal (UGI) cancers is associated with numerous
side-effects including sarcopenia and nutritional compromise, increasing morbidity,
compromising functional capacity and decreasing health-related quality of life (HR-QOL) in
survivorship. As survival improves in UGI cancer, there is increasing focus on optimizing
survivorship, however research examining rehabilitation programs in this newly-emergent
complex clinical cohort is lacking.
The investigators recently designed, implemented, and evaluated the Rehabilitation Strategies
following Oesophagogastric Cancer (RESTORE) program, a novel multidisciplinary rehabilitation
program tailored for oesophagogastric cancer survivorship. The feasibility and preliminary
efficacy of the RESTORE program was established and there is now recognized need to further
examine program efficacy in a definitive trial.
Using a convergent parallel mixed-methods design, RESTORE II, implemented as a 2-armed
randomized controlled trial, will examine if multidisciplinary rehabilitation can improve
functional capacity and HRQOL in UGI cancer survivors. RESTORE II will prescribe a 12-week
program of supervised aerobic and resistance training, self-directed unsupervised exercise,
individualized dietetic counselling and multidisciplinary education for patients who are >3
months following oesophagectomy, gastrectomy, pancreaticoduodenectomy, or major liver
resection. A sample of 60 participants per arm will be recruited to establish a mean increase
in functional capacity (cardio-respiratory fitness) of 3.5 ml/kg/min with 90% power, 5%
significance and 20% drop-out.
Quantitative assessments including cardiopulmonary fitness and functional exercise capacity
will be completed at baseline, post-intervention and 3-months post-intervention (Objective
1). HR-QOL will be quantitatively assessed pre and post-intervention, at 3-months
post-intervention and 1 year post-enrollment (Objective 2). Impact on physical, mental and
social well-being will be qualitatively examined during focus groups immediately
post-intervention and 3-months post-intervention (Objective 3). The implementation costs of
RESTORE II will be analysed in consideration of clinician salaries, overheads and equipment
costs (Objective 4). Bio-samples will be collected pre and post-intervention and 3-months
post-intervention, establishing the first National UGI Cancer Survivorship Biobank (Objective
5). A patient centered approach to enhancing trial recruitment in this complex cohort will
also be evaluated (Objective 6).
Following this evaluation, the RESTORE II program will provide a unique model of
multidisciplinary rehabilitation in nutritionally complex UGI cancer survivors.