Effectiveness of a Personalized 6-month Programme on Frailty in Older Patients Treated for Bladder or Kidney Cancer - FRAGECO - Multicenter, Controlled, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Patient frailty
研究概览
简要总结
Bladder and kidney cancers are commonly diagnosed in older adults. Surgery remains the primary treatment modality for patients with kidney or bladder cancer. In older patients, common co-morbidities include fatigue, physical deconditioning characterized by reduced cardiorespiratory fitness and progressing sarcopenia, pain- whether disease- related or treatment-induced- and undernutrition. These factors increased the risk of post-operative complications and exacerbate patient frailty.
The investigators propose a personalized 6-month program both pre- and post-surgery, including adapted physical activity sessions, therapeutic education workshops, and systematic referral to the department's DAPAP program.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bladder or kidney cancer
- •Surgical treatment
- •No severe cognitive impairment preventing understanding of the protocol
- •Affiliated or entitled to a social security scheme
- •Having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study
排除标准
- •Surgery already done
- •Significant co-morbidities that contraindicate physical activity: associated cardiac pathologies, respiratory pathologies, disabling joint pathologies, etc.
- •Deprived of liberty or under guardianship
- •Benefiting from a prehabilitation prescription with a private physiotherapist.
研究组 & 干预措施
Control group
The control group will consist of patients with bladder or kidney cancer receiving standard care, which includes a comprehensive assessment by an oncogeriatrician followed by surgery approximately 4 weeks later. Postoperatively, patients will be transferred to a rehabilitation center (SSR) for recovery, in line with standard clinical practice.
As part of the study protocol, control group patients will undergo additional follow-up assessments alongside their usual care. These follow-ups-conducted at baseline, and at 1, 2, 3 months, and at the final endpoint-will mirror those of the intervention group. They will include patients- completed questionnaires and physical assessments conducted by an adapted physical activity teacher.
Interventional group
The interventional group will consist of bladder and kidney cancer patients who will follow a personalized 6-month care pathway in addition to standard care. This pathway includes:
- 2 adapted physical activity (APA) sessions per week for 4 weeks prior to surgery
- 2 APA sessions/ week for 4 weeks following surgery
- Therapeutic education workshops tailored to individual needs, covering topics as physical activity, nutrition, treatments, fatigue, and relaxation
- Referral to the department's DAPAP for a 12-week "bridge program", consisting of one APA session per week.
The study will be conducted in the oncogeriatrics departments of Saint-Etienne University Hospital and Loire Private Hospital.
干预措施: APA (Procedure)
Interventional group
The interventional group will consist of bladder and kidney cancer patients who will follow a personalized 6-month care pathway in addition to standard care. This pathway includes:
- 2 adapted physical activity (APA) sessions per week for 4 weeks prior to surgery
- 2 APA sessions/ week for 4 weeks following surgery
- Therapeutic education workshops tailored to individual needs, covering topics as physical activity, nutrition, treatments, fatigue, and relaxation
- Referral to the department's DAPAP for a 12-week "bridge program", consisting of one APA session per week.
The study will be conducted in the oncogeriatrics departments of Saint-Etienne University Hospital and Loire Private Hospital.
干预措施: Therapeutic education workshops (Behavioral)
Interventional group
The interventional group will consist of bladder and kidney cancer patients who will follow a personalized 6-month care pathway in addition to standard care. This pathway includes:
- 2 adapted physical activity (APA) sessions per week for 4 weeks prior to surgery
- 2 APA sessions/ week for 4 weeks following surgery
- Therapeutic education workshops tailored to individual needs, covering topics as physical activity, nutrition, treatments, fatigue, and relaxation
- Referral to the department's DAPAP for a 12-week "bridge program", consisting of one APA session per week.
The study will be conducted in the oncogeriatrics departments of Saint-Etienne University Hospital and Loire Private Hospital.
干预措施: DAPAP (Procedure)
结局指标
主要结局
Patient frailty
时间窗: Day : 1 and Month : 6
Frailty will be measured using the walking distance (in metres) achieved during the 6-minute walk test (6MWT) 6 months after the patient's inclusion.
次要结局
- Healthy quality of life(Months : 1, 2, 3 and 6)
- Depression(Months : 1, 2, 3 and 6)
- Balance(Months : 1, 2, 3 and 6)
- Cumulative Illness Rating Scale for Geriatrics (CIRS-G)(Months : 1, 2, 3 and 6)
- level of sedentary lifestyle(Months : 1, 2, 3 and 6)
- Fried's frailty phenotype (FP)(Months : 1, 2, 3 and 6)
- level of physical activity(Months : 1, 2, 3 and 6)
- Nutritional status(Months : 1, 2, 3 and 6)
- Fatigue(Months : 1, 2, 3 and 6)
- Memory(Months : 1, 2, 3 and 6)
- Muscular strength(Months : 1, 2, 3 and 6)