Pilot Study
Conditions
Brief summary
Prehabilitation programmes have the potential to reduce post-operative complications following abdominal cancer surgery by improving pre-operative fitness levels. Home-based prehabilitation programmes may be more cost effective than hospital-based programmes, but have issues with low compliance. The aims of our study are to assess whether mobile technologies such as smart watches and smartphone applications improve compliance with home-based prehabilitation programmes and to assess the effects of prehabilitation on pre-operative fitness levels in patients due to undergo major abdominal cancer surgery.
Detailed description
30 patients due to undergo major abdominal cancer surgery at The Christie NHS Foundation Trust will be enrolled to a pilot randomised controlled trial. They will randomised to either a home-based trimodal prehabilitation programme, delivered by the use of FitBit Smart Watches and Smartphone applications, or a control group who will receive a FitBit for physical activity monitoring only, for a period of 2-6 weeks prior to surgery. The prehabilitation programme will include exercise, nutritional, and psychological components. Study outcomes will include 6MWT (6-minute walk test), HADS (hospital anxiety and depression score), steps per day, length of stay post-operatively, and post-operative complications.
Interventions
OTHERMonitoring using a FitBit
Each participant will receive a Fitbit. The Prehabilitaiton Group will receive a Fitbit Charge 2 and they will be able to review their progress on this and be required to increase their exercise activity and input information and data about the exercise they have completed each day during their participation in the study. The Control group will receive a Fitbit Flex and will not be required to review any of their activity or input any data and will be encouraged to continue with their daily activity rates i.e. not to change.
Sponsors
The Christie NHS Foundation Trust
Shira Baram
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
There is no masking. Both the investigator and participant will be aware of which arm they have been randomised to.
Intervention model description
Participants will be randomised sequentially i.e. 1:1 to receive either the Prehabilitation Programme or not
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* be aged 18 years or over * be able to consent to participate in the prehabilitation programme * be undergoing major abdominal cancer surgery (including, but not limited to, cytoreductive surgery with hyperthermic intraperitoneal chemotherapy) * have at least 2 weeks to their operation date * be able to understand written and spoken English
Exclusion criteria
* patients have any health conditions which will prevent them from safely taking part in a home-based exercise programme. For example, but not limited to, patients who have recently (within the past 3 months) had a myocardial infarction or a stroke or patients who have end-stage renal disease but are not on dialysis. We will use the Safety Reference Guide to support exercise services in people with cancer in The Lancet published paper Exercise as part of routine cancer care(5) to aid the screening of patients suitability. * they have any bone metastasis * are already active users of a FitBit device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative data collected via a Fitbit | Each participant will be monitored for a period of 2-6 weeks pre surgery | Data will be collected to determine the number of participants whose physical activity increased and by how much during the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative data collected by questionnaire | Each participant will be monitored for a period of 2-6 weeks pre surgery | Qualitative data will be collected from participants to identify their experience of the study |
| Quantitative data associated with participants weight at the start and end of the research intervention | Each participant will be monitored for a period of 2-6 weeks pre surgery | Participants weight will be measured in kilograms at the start of their participation and then prior to surgery to determine if they were able to either maintain their weight or gain weight |
Countries
United Kingdom
Contacts
Primary ContactShira Baram
Outcome results
None listed