Dynamics of Motivational Factors for Physical Activity and Nutrition in Oncogeriatrics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- For Interventionnal phase : Improving nutrition behaviors of elderly cancer patients
研究概览
简要总结
Oncogeriatric: a collaboration between oncologists and geriatricians which aims to ensure that all elderly cancer patients receive treatment adapted to their condition, thanks to a multidisciplinary and multi-professional approach.
This project aims to gain a better understanding of the motivational determinants of PA and nutrition in elderly cancer patients.
It has a dual objective:
- to identify clusters/groups in patients on the basis of daily motivational factors focusing on PA and nutrition
- on the basis of the results obtained in (1), to propose an interventional study based on the previously established clusters, in order to examine the effects of a behavioral intervention on patients' adherence to PA and nutrition, both agreed according to an individualized goal and defined in agreement with the patient and the multidisciplinary team, taking into account the recommendations.
详细描述
While cancer is the leading cause of death in people aged 75 to 85, and the second leading cause of death in people over 85 , there is little evidence in the elderly due to their under-representation in clinical trials. This under-representation increases the risk of under- or over-treatment in this population, making the elderly even more vulnerable to chemotherapy-related toxicities [3]. There is considerable heterogeneity in the population of patients over 70. Some advance in age with few comorbidities and maintained independence, while others combine several chronic pathologies and deficits . Treatments to combat these comorbidities are sometimes subject to drug interactions with anticancer therapies, which makes prescribing treatments all the more difficult in oncogeriatrics. The balance between quality of life and quantity of life is fundamental in drawing up a care plan [5]. Support for the elderly cancer patient must be comprehensive and individualized, incorporating the patient's opinion and a multidisciplinary approach to meet all identified needs .
Physical inactivity and undernutrition: risky behaviours leading to over-toxicity of treatments, worsening of co-morbidities and increased risk of mortality.
Ageing leads to physiological changes (hormonal, metabolic, etc.) and an increase in risk behaviours, including physical inactivity and undernutrition [6,7]. These are responsible for a loss of strength and muscle mass [8], exacerbated by cancer and its treatments [9], a phenomenon all the more marked in the elderly.
This progressive and generalized loss of muscle mass and strength is associated with a deterioration in physical capacity and high rates of hospitalization and mortality.Reduced muscle mass is associated with over-toxicity to chemotherapies, with a direct impact on survival.Reduced muscle strength is an important predictor of adverse events such as falls .Beyond muscle-related issues, these risk behaviors associated with aging also lead to the onset of other comorbidities and a higher risk of mortality .
In this context, nutritional monitoring and physical activity (PA) are two complementary and effective interventions for maintaining muscle status and preventing undernutrition during oncology treatment. More specifically, prevention and management of this loss of muscle mass and strength should be based on adequate energy and protein intake and multimodal PA (including muscle strengthening coupled with exercise conditioning) at moderate intensity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 70 or over
- •With cancer (solid tumors, all sites)
- •Inactive (patient not meeting recommended physical activity levels of 150 minutes per week at moderate intensity)
- •Patient has given informed, written and express consent
- •Patient affiliated to a French social security scheme.
排除标准
- •Known presence of brain metastases
- •Inability to participate in digital platform assessments or physical tests
- •Inability to eat orally
- •Contraindication or inability to engage in physical activity
- •Patient unable to follow up regularly for psychological, family, numerical, social or geographical reasons
- •Person deprived of liberty or under protective custody or guardianship.
研究组 & 干预措施
Observation phase and Intervention phase
This study is divided into two distinct parts (phase):
- A first observational part, already carried out, with the specific aim of assessing the relationship between motivation and behavior, for physical activity and nutrition.
The observational part enabled us to observe the relevant motivational levers for developing the second part of the study, the interventional part.
- The specific aim of the second, interventional part, in which we are inviting you to take part, is to improve physical activity and nutrition behaviours through the implementation of a behavioural intervention*.
干预措施: Collecting the variables and Implementation of a behavioural intervention (Behavioral)
结局指标
主要结局
For Interventionnal phase : Improving nutrition behaviors of elderly cancer patients
时间窗: from baseline at 12 weeks
Quality of nutrition questionnaire (Ingestas)
For observationnal phase : Identify relevant motivational levers in order to build a personalized and adapted behavioral intervention to improve physical activity and nutrition behaviors, via cluster analysis.
时间窗: from baseline at 15 days
Clusters (groups of patients) evaluated by the "silhouette coefficient" and seprated by behavior, on one hand concerning Physical Activity (PA) and on the other hand concerning nutrition.
For Interventionnal phase : Improving physical activity behaviors of elderly cancer patients
时间窗: from baseline at 12 weeks
Number of physical activities
次要结局
- Measure the population's adherence to a methodology using digital tools and data collection via EMA.(at 15 days and at 12 weeks)
- Study acceptance of participation in the study and reasons for refusal(at 15 days and at 12 weeks)
