STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation for Risk Reduction in Cancer Surgery

Study Overview
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Brief Summary
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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
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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 (38 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 (20 patients). The intervention groups receive minimum five educational sessions tailored to individual needs over six weeks perioperatively. The control groups receive standard care.

Official Title
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STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation Including Smoking, Nutrition, Alcohol and Physical Activity for Risk Reduction in Cancer Surgery

Conditions
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Risk Reduction, Urological Cancer, Surgery, Life Style

Intervention / Treatment
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* Behavioral: Prehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised Controlled Trials, Implementation feasibilty trial, Interviews nested
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation<br>Intervention: Patients allocated to the intervention group receive weekly counselling sessions in 6 weeks as an integrated prehabilitation program tailored to meet the individual patient's need for risk reduction at surgery. It is introduced via the surgical 'Engage in the process of change'. The smoking and alcohol cessation intervention follows the Gold Standard Programme and patients in the intervention group are introduced to a standardized exercise training programme taking individualized needs into account. Nutritional support is also individualized. | Behavioral: Prehabilitation<br>* Patients screened positive for minimun 1 SNAP factor will be offered enrollment in the study and have an individualized plan for the prehabilitation intervention.<br>* Other names: smoking cessation, alcohol cessation, physical activity, nutritional support for malnutrition and obesity;|
| No Intervention: Treatment as usual<br>Treatment as ususal covers shorter interventions, e.g. advice, brief counselling, and handing out the national folders on smoking and alcohol and surgery. Patients are ensured that they are free to access support to lifestyle changes in the community. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number 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) | End of intervention/ at surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Smoking, Postoperative complications, Prehabilitation, Surgical risk reduction, Alcohol drinking, Physical activity, Malnutrition, Patient preferences, Randomised controlled trial