STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation Including Smoking, Nutrition, Alcohol and Physical Activity for Risk Reduction in Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of patients with risk reduction at surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will not know if patients were allocated to intervention or control group
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years scheduled for cystectomy due to bladder cancer
- •Referral to neoadjuvant chemotherapy
- •Screened positive for minimum 1 SNAP factor
- •Signed informed consent
排除标准
- •Pregnancy and breastfeeding
- •Allergy to pharmaceutical support (Nicotine Replacement Therapy, Disulfiram)
- •Contraindications to exercise.
研究组 & 干预措施
Treatment as usual
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.
Prehabilitation
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.
干预措施: Prehabilitation (Behavioral)
结局指标
主要结局
Number of patients with risk reduction at surgery
时间窗: 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)
次要结局
- Number of successful tobacco quitters(6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months)
- Health related quality of life (HRQoL)(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(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(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(6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months)
- Number of patients with improved frailty level(6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months)
- Number of patients with any postoperative complication(30 days)
- 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)
- Number of successful alcohol quitters(6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months)
研究者
Hanne Tonnesen
Professor
Bispebjerg Hospital