Despite knowledge about the effect of preventive measures in lifestyle, smoking,nutrition, alcohol and physical activity (SNAP), there is a lack of systematic assessment of the overall lifestyle of the patient before surgery and knowledge about how lifestyle interventions can be organized in connection with cancer surgery. The intention with prehabilitation is to optimize the individual's risk factors and personal burdens that can affect the clinical and patient reported outcomes after surgery. The aim of this study is to evaluate the efficacy of intensive SNAP interventions compared to treatment as usual (TAU) in ptt undergoing urological cancer surgery on surgical risk reduction.
The project contains three clinical intervention studies, in total including 100 urological cancer patients screened positive for at least 1 SNAP factor: I. Efficacy and preferences of intensive SNAP-Interventions among patients with at least one SNAP factor and undertaking neo-adjuvant chemotherapy before radical cystectomy. A randomised controlled trial with nested interviews (42 patients). II. Implementation and preferences of intensive SNAP-Interventions among patients with kidney cancer undergoing nephrectomy/partial nephrectomy. An implementation feasibility study including interviews (20 patients). III. Reach out and effect as well as preferences of perioperative intensive smoking cessation intervention via the municipality clinic compared to the surgical department among smokers with non-invasive bladder cancer treated with Trans-Urethral Resection of the Bladder (TUR-B). A randomised controlled trial with nested interviews (38 patients). The intervention groups receive minimum five educational sessions tailored to individual needs over six weeks perioperatively. The control groups receive standard care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Patients screened positive for minimun 1 SNAP factor will be offered enrollment in the study and have an individualized plan for the prehabilitation intervention.
Dept Urology 2112, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Region H, Denmark
RECRUITINGNumber of patients with risk reduction at surgery
Corresponding at least 1 step for 1 or more risky lifestyles (but only smoking in study III) on the ASA-score (American Society of Anaesthesiologists physical status classification from 1-5, lower is better)
Time frame: End of intervention/ at surgery
Health related quality of life (HRQoL)
Mean difference of HRQoL between groups measured with EQ5D (5 level quality of life score (level 1 =no problems, level 2-5 =problems)
Time frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Number of patients with any postoperative complication
Scored by the Comprehensive Complication Index, a linear scale ranging from 0 (no complication) to 100 (death)
Time frame: 30 days
Number of successful tobacco quitters
Successful quitting smoking: Study I+ II+ III * Successful quitting alcohol intake at 6 weeks and below risky limits at 6 months: Study I. * Physical activity at least 30 minutes per day: Study I. * Malnutrition: Not at risk of malnutrition: Study I. Obesity: 5% -10 % loss of body fat mass and below 1% gain of body fat mass at 6 months (without developing malnutrition)
Time frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Number of successful alcohol quitters
Successful quitting alcohol: Study I+II
Time frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Number of patients being physical active at least 30 min per day
Minutes physical active measured by an accelerometer (longer time is better) : Study I+II
Time frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Number of patients not at risk of malnutrition
NRS2002 (Nutritional Risk Screening 2002) score\>2. Lower is better: Study I+II
Time frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Number of patients not at risk of obesity
BMI (Body Mass Index)\<30. Lower is better : Study I+II
Time frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Number of patients with improved frailty level
Measured by Lammers definition: Lower is better: Study I+II+III
Time frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Number of patients with any reduction in lifestyle
Measured by yes/no. Study I+II+III
Time frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
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