Grant title
Effect of a 12-week exercise training intervention on health related quality of life in patients after surgery for oesophageal cancer
Scientific abstract
Background
Oesophageal cancer (OC) has for some years been the fastest growing malignancy in the western world. Survival of OC has slowly improved over the past 10–15 years as a result of improved surgical techniques, peri-operative care, and chemo- and/or radiotherapy regimens. Five-year survival of patients, who undergo surgery with curative intent combined with prior chemoradiation is 47%. OC surgery is an extensive procedure with high risk of post-operative complications and persisting morbidity.
Patients after surgery are often fatigued and have a decreased health-related quality of life (HRQoL) and physical functioning in the short- and long-term. Therefore, interventions that potentially increase HRQoL are strongly needed. Exercise training interventions have been shown to effectively improve HRQoL in patients with various types of cancer. So far, comparable evidence for patients with OC is lacking.
Hypothesis and objectives
We propose to perform a multi-centre randomised controlled trial (RCT) investigating the effect of a 12-week exercise training intervention on OC patients’ HRQoL compared with a usual care control group.
Setting and methods
In this RCT, 150 patients after surgery for OC from five centres will be included. The exercise training intervention will start 4–8 weeks post-discharge (ie, approximately 6–10 weeks post-surgery) and consists of two-weekly endurance and resistance training sessions supervised by a physiotherapist in an outpatient or general physiotherapy practice close to the patients’ home. Patients will also be asked to be physically active for at least 30 minutes a day, every day a week according to the WCRF/AICR guidelines for cancer survivors.
Outcome measures will be assessed at baseline and 12-weeks post-baseline (ie, end of exercise intervention) and 24-weeks post-baseline. Patients will be followed for recurrence or death up to five years (two years within this project).
The primary outcome is HRQoL, assessed using the EORTC QLQ-C30. Secondary outcomes are physical fitness (assessed by a cardiopulmonary exercise test and muscle strength tests) and physical functioning, fatigue, anxiety and distress, body composition, sleep quality, disease recurrence and overall survival. Multi-level linear mixed models and generalised estimating equations adjusted for key prognostic factors will be used for statistical analyses.
Impact
To date, routine care of patients after OC surgery is mainly focused on the detection of recurrent or metastatic disease. Problems such as decreased HRQoL, fatigue and decreased fitness, which are frequently reported, are less well addressed and effective interventions are lacking.
The proposed study will obtain insight in whether exercise training positively affects HRQoL, recurrence and overall survival. If effective, results will be implemented in the aftercare and patients with OC will benefit by receiving evidence based rehabilitation care and through this HRQoL will presumably improve.
Plain language abstract
Background
Oesophageal cancer (OC) has for some years been the fastest growing malignancy in the western world. Survival of OC has somewhat improved over the past 10–15 years as a result of better surgical techniques, peri-operative care, and chemo- and/or radiotherapy regimens. OC surgery is, however, an extensive procedure and the risk of post-operative complications is high. Patients after surgery are often fatigued and have a decreased health-related quality of life (HRQoL) and physical functioning in the short- and long-term.
Therefore, interventions that potentially increase HRQoL are strongly needed. Exercise training interventions (eg endurance training on a bicycle or muscle strength training) have been shown to improve HRQoL in patients with various types of cancer. So far, the effect of exercise training for patients with OC has not been investigated yet.
Aims and objectives
We propose to perform a randomised controlled trial (RCT) investigating the effect of a 12-week exercise training intervention on OC patients’ HRQoL compared with a usual care control group.
How will it be done
In this RCT, 150 patients after surgery for OC from five hospitals in the Netherlands will be included and will be randomly assigned to either the exercise training or usual care, ie no exercise. The exercise training intervention will start 4–8 weeks after discharge from the hospital where surgery was performed.
The intervention consists of two weekly endurance and resistance exercise training sessions supervised by a physiotherapist in an outpatient or general physiotherapy practice close to the patients’ home. Patients will also be asked to be physically active for at least 30 minutes a day, every day a week according to the WCRF/AICR guidelines for cancer survivors.
Outcome measures will be assessed at baseline and 12 weeks post-baseline (ie, end of exercise intervention) and 24 weeks post-baseline. Patients will be followed for recurrence or death up to five years (two years within this project). The primary outcome is HRQoL, assessed using the EORTC QLQ-C30.
Secondary outcomes are physical fitness (assessed by a cardiopulmonary exercise test and muscle strength tests) and physical functioning, fatigue, anxiety and distress, body composition, sleep quality, disease recurrence and overall survival.
Potential impact
To date, routine care of patients after OC surgery is mainly focused on the detection of recurrent or metastatic disease. Problems such as decreased HRQoL, fatigue and decreased fitness, which are frequently reported, are less well addressed and effective interventions are lacking. The proposed study will obtain insight in whether exercise training positively affects HRQoL and recurrence, and overall survival.
If effective, results will be implemented in the aftercare and patients with OC will benefit by receiving evidence based rehabilitation care and through this HRQoL will presumably improve.
