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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation | Experimental | 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. |
|
| Treatment as usual | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation | Behavioral | Patients screened positive for minimun 1 SNAP factor will be offered enrollment in the study and have an individualized plan for the prehabilitation intervention. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanne Tønnesen, Professor MD | Contact | +4538163840 | hanne.tonnesen@regionh.dk | |
| Susanne V Lauridsen, PhD | Contact | +4535451704 | susanne.vahr.lauridsen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Hanne Tonnesen, Professor MD | WHOCC, The Parker Institute, Bispebjerg-Frederiksberg Hospital, RegH, Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept Urology 2112, Copenhagen University Hospital, Rigshospitalet | Recruiting | Copenhagen | Region H | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35449008 | Derived | Tonnesen H, Lydom LN, Joensen UN, Egerod I, Pappot H, Lauridsen SV. STRONG for Surgery & Strong for Life - against all odds: intensive prehabilitation including smoking, nutrition, alcohol and physical activity for risk reduction in cancer surgery - a protocol for an RCT with nested interview study (STRONG-Cancer). Trials. 2022 Apr 21;23(1):333. doi: 10.1186/s13063-022-06272-2. |
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| ID | Term |
|---|---|
| D040242 | Risk Reduction Behavior |
| D014571 | Urologic Neoplasms |
| D011183 | Postoperative Complications |
| D012907 | Smoking |
| D000428 | Alcohol Drinking |
| D009043 | Motor Activity |
| D044342 | Malnutrition |
| D009765 | Obesity |
| D057240 | Patient Preference |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| D000431 | Ethanol |
| D015444 | Exercise |
| D018529 | Nutritional Support |
| D050154 | Adiposity |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Randomised Controlled Trials, Implementation feasibilty trial, Interviews nested
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Outcome assessors will not know if patients were allocated to intervention or control group
|
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
| 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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014570 | Urologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004327 | Drinking Behavior |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D017060 | Patient Satisfaction |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D009043 |
| Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D044623 | Nutrition Therapy |
| D050218 | Body Fat Distribution |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D001823 | Body Composition |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D008660 | Metabolism |
| D010829 | Physiological Phenomena |