Life Style, Risk Reduction, Surgery, Urological Cancer
Conditions
Keywords
Postoperative complications, Prehabilitation, Surgical risk reduction, Smoking, Alcohol drinking, Physical activity, Malnutrition, Obesity, Patient preferences, Randomised controlled trial
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPrehabilitation
Patients screened positive for minimun 1 SNAP factor will be offered enrollment in the study and have an individualized plan for the prehabilitation intervention.
Sponsors
Rigshospitalet, Denmark
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will not know if patients were allocated to intervention or control group
Intervention model description
Randomised Controlled Trials, Implementation feasibilty trial, Interviews nested
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients \> 18 years scheduled for cystectomy due to bladder cancer * Referral to neoadjuvant chemotherapy * Screened positive for minimum 1 SNAP factor * Signed informed consent
Exclusion criteria
* Pregnancy and breastfeeding * Allergy to pharmaceutical support (Nicotine Replacement Therapy, Disulfiram) * Contraindications to exercise.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with risk reduction at surgery | End of intervention/ 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with any postoperative complication | 30 days | Scored by the Comprehensive Complication Index, a linear scale ranging from 0 (no complication) to 100 (death) |
| Number of successful tobacco quitters | 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months | 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) |
| Number of successful alcohol quitters | 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months | Successful quitting alcohol: Study I+II |
| Number of patients being physical active at least 30 min per day | 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months | Minutes physical active measured by an accelerometer (longer time is better) : Study I+II |
| Health related quality of life (HRQoL) | 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months | Mean difference of HRQoL between groups measured with EQ5D (5 level quality of life score (level 1 =no problems, level 2-5 =problems) |
| Number of patients not at risk of obesity | 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months | BMI (Body Mass Index)\<30. Lower is better : Study I+II |
| Number of patients with improved frailty level | 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months | Measured by Lammers definition: Lower is better: Study I+II+III |
| Number of patients with any reduction in lifestyle | 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months | Measured by yes/no. Study I+II+III |
| Number of patients not at risk of malnutrition | 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months | NRS2002 (Nutritional Risk Screening 2002) score\>2. Lower is better: Study I+II |
Countries
Denmark
Contacts
Primary ContactHanne Tønnesen, Professor MD
Backup ContactSusanne V Lauridsen, PhD
Outcome results
None listed