Rectal cancer Cancer Malignant neoplasm of rectum
Conditions
Interventions
The patients randomized to the walking group will have a consultation with the Project Co-ordinator (PC) where the walking intervention, including the use of the pedometer, will be explained with step
Sponsors
NHS Greater Glasgow and Clyde (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Any patient over 18 years of age 2. Independently mobile 3. Has been diagnosed with rectal cancer 4. Planned first line of treatment is chemotherapy and radiotherapy followed by curative surgery (timing at discretion of surgeon, but expected between 10-12 weeks post-CRX)
Exclusion criteria
Exclusion criteria: 1. Chemotherapy and radiotherapy not first-line treatment 2. Patient has had previous malignancies 3. Significant co-morbidity where inclusion into this trial would put the patient?s health at risk 4. Patient has any mental, physical or psychological impairment that prevents them from giving signed informed consent 5. Patient is already achieving their recommended activity level per week where participation in a walking programme would mean he/she would be exercising at a lower level than normal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the feasibility of performing a walking intervention in patients with rectal cancer undergoing pre-operative chemo-radiotherapy. 2. How many patients can be recruited per month on average and what proportion of eligible patients are willing to be recruited? 3. Are patients willing to be randomised? 4. What is the initial retention and adherence levels that can be achieved for the programme in both interventional and control groups? 5. How many patients drop out of such a study and for what reasons? 6. Are patients able to carry out the intervention as planned and can it be successfully implemented? 7. How acceptable are the intervention, the delivery of, the duration of, the intensity of and the exit strategy to the participants? 8. What are the indicative cost implications of intervention delivery? To assess primary and secondary outcomes, Tests 1 and 2 will be performed at two time points: pre-chemo-radiotherapy and post-chemo-radiotherapy/pre-surgery (referred to as Test 1 and Test 2, respectively). These tests include: feasibility measurements; body mass index, hip and waist circumference; sit-to-stand test, 6-minute walking test; sedentary time, active time, average steps walked per day. Psychological and quality of life will also be assessed at Tests 1 and 2 by: Becks Depression Inventory (BDI-II), FACT-C, PANAS, EORTC-QLQ C30. Peri-operative outcomes will be recorded during the patient's in-hospital stay post-surgery and for up to 30 days after surgery (length of hospital stay, length of level 2 stay, complications, time to medical discharge, mortality). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Does pre-habilitation increase the number of steps walked per day? 2. Does pre-habilitation lead to improved recovery after surgery (in terms of time to step down from critical care; incidence of morbidity and time to discharge from hospital)? 3. Does pre-habilitation increase the average time spent per day in physical activity? 4. Does pre-habilitation decrease the average time spent per day in sedentary behaviour? 5. Does pre-habilitation lead to reduced fatigue and improved psychological and quality of life parameters? | — |
Countries
Scotland, United Kingdom
Outcome results
None listed