To study the effectiveness of a blended intervention, focused on personal feedback and coaching regarding physical activity and protein intake, after hospital discharge in patients who have undergone elective GI or lung cancer surgery on the outcome…
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal therapeutic procedures
Synonym
Health condition
lever en galwegen therapeutische verrichtingen & luchtwegen therapeutische verrichtingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is postoperative recovery in physical functioning
measured with the CAT PROMIS-physical functioning item bank. The most important
secondary outcome is objectively measured level of physical activity (active
minutes per day).
Secondary outcome
To study the effectiveness of a blended intervention after discharge in
patients have undergone elective gastro-intestinal or lung cancer surgery on
the following outcome measures:
o Physical activity
o Protein intake
o Lean body mass
o Physical performance
o Patient specific activity limitations
o Pain
o Fatigue
o Self-efficacy
o Quality of life
o Global perceived effect
o Participation in social roles and activities
o CT-determined muscle mass
o Postoperative complications
o Unplanned hospital readmission within 30 days after discharge
o Adverse events
Background summary
Gastro-intestinal (GI) and lung cancer are among the most common types of
cancer, with an incidence of 23.373 and 14.424 in the Netherlands in 2019,
respectively. Surgery is often an essential curative treatment option for these
patients, however it has a major impact on daily functioning and quality of
life. Many patients experience an incomplete or delayed recovery of physical
functioning. Improving physical activity (PA) after surgery has the potential
to reduce complications and to promote better and faster functional recovery.
In addition to stimulating PA, it is also important to stimulate protein
intake, as previous studies have shown that many surgical patients were unable
to meet their protein needs, which may affect their functional recovery.
Study objective
To study the effectiveness of a blended intervention, focused on personal
feedback and coaching regarding physical activity and protein intake, after
hospital discharge in patients who have undergone elective GI or lung cancer
surgery on the outcome 'recovery of physical functioning' compared to usual
care.
Study design
Multicentre single-blind randomized controlled intervention study.
Intervention
The blended intervention consists of a smartphone application and corresponding
accelerometer in combination with coaching by a physiotherapist and dietician.
With the app, patients are able to self-monitor their daily protein intake and
PA level, have insight in personal goals on protein intake and receive
(real-time) feedback. The patients receive an ankle-worn PA monitor (PAM) and
corresponding application one week prior to surgery to get familiarized with
the application. After discharge, the patients continue the use for 3 months
and patients will be monitored and coached by a physiotherapist and dietician
during this period. The intervention will be tailored on the patients personal
needs and preferences based on a shared decision making process with the
patient. The patients will be coached by the physiotherapist and dietician
following the principles of Motivational Interviewing.
Study burden and risks
No changes in surgical or medical therapy will occur due to this trial. The
focus of the intervention is to improve physical activity and protein intake
after surgery, both of which are important elements within the usual
postoperative care. To stimulate patients to increase physical activity and
protein intake, the investigational software Atris (Recovery Triggers) will be
used, which is considered a medical device. Given the limited risk associated
with the use of Atris (Recovery Triggers) software and the potential benefits,
the risk of added harm is small. Based on current evidence, this study is
clinically relevant and is associated with a minimal risk. However, all
participating patients have an additional time burden of filling out
questionnaires at six time points and physical performance tests will be
measured 4 times.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
- Scheduled for GI- or lung surgery
- Age >= 18 years
- Surgery with curative intent
- Indication for postoperative hospital stay >= 2 nights
- Able to fill in online questionnaires in Dutch
- Able to give informed consent
Exclusion criteria
- Wedge excision lung
- Surgery with open/close procedure
- No access to a mobile device compatible for applications
- Mini-Mental State Examination (MMSE) <= 24
- Less than 5 days between inclusion and surgery
- Patients who are wheelchair dependent
- Already participating in a conflicting study (to be determined per
participating centre)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL78840.029.21 |
| OMON | NL-OMON24920 |