Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445140
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-05-22
Brief Title:
Dynamics of Motivational Factors for Physical Activity and Nutrition in Oncogeriatrics
Sponsor:
Institut du Cancer de Montpellier - Val dAurelle
Organization:
Institut du Cancer de Montpellier - Val dAurelle
Study Overview
Official Title:
Dynamics of Motivational Factors for Physical Activity and Nutrition in Oncogeriatrics
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MONAGE
Brief Summary:
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
1 to identify clustersgroups in patients on the basis of daily motivational factors focusing on PA and nutrition
2 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
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
1 to identify clustersgroups in patients on the basis of daily motivational factors focusing on PA and nutrition
2 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
Detailed Description:
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 patients 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 67 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 mortalityReduced muscle mass is associated with over-toxicity to chemotherapies with a direct impact on survivalReduced 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
These recommendations apply to both primary age-related mass loss and secondary disease-related mass loss
Although an intervention combining nutritional monitoring and regular PA practice is recognized as effective in maintaining muscle status and preventing undernutrition it is difficult to achieve high adherence and lasting behavioural changes to move the elderly towards a more active lifestyle and to change their eating habits
The theory of planned behavior a theoretical approach that facilitates behavior change towards an active lifestyle associated with adapted nutritional behaviors
Identifying the motivational factors associated with PA and nutrition in this population could help facilitate the adoption and sustainability of these behaviours
The literature indicates that using a theoretical approach to identify motivational factors associated with PA and nutrition is important to facilitate behavior change and hope for higher adherence A meta-analysis has shown that no theory is superior to another in terms of effectiveness for modifying PA and that interventions are more effective when based on a single theory rather than a combination of theories In this respect the theory of planned behavior TCP is commonly used in the study of behavior change particularly for an aging population Figure 1 This theory assumes that the adoption of a behavior stems from the formation of intentions in the individual These intentions are facilitated by attitudes subjective norms particularly in the caregiver and self-perceived behavioral control
Attitudes represent the benefits perceived by the individual in performing the behavior ie benefits related to the usefulness of the behavior and those related to the pleasure of performing it
Subjective norms correspond to the individuals social influence represented by what those around him think of the behavior he wants to undertake
Perceived behavioral control refers to the perceived ease or difficulty of performing the behavior and thus to the individuals belief that he or she possesses the necessary resources to perform the behavior Moreover this variable is assumed to be directly related to behavior
However TCP has been criticized for its variable prediction of behavioral intentions Indeed the designs used are based on a limited number of measures failing to take into account the temporal fluctuation of perceptions and intra-individual variability In response to these methodological limitations Maher and colleagues investigated the use of repeated-measures methods to assess the relationship between intentions and behavior In particular the study revealed that intentions can vary according to the time of day reflecting the dynamics of motivational variables As a result repeated-measures methods are effective for measuring TCP variables as they identify the contexts most conducive to putting intentions into action
In this respect the Ecological Momentary Assessment EMA method enables repeated sampling of behaviors and psychological variables in real time which could take into account the temporal fluctuation of perceptions
This data collection method is suitable for measuring TCP variables and could improve their predictive level It is feasible with high compliance above 80 in the elderly
Behavior change techniques an effective individualized intervention to optimize the adoption and sustainability of health behaviors
In oncology and geriatrics intervention research indicates that an increase in TCP variables is accompanied by a significant increase in PA levels Interventions based on behavior change techniques BCT alone or in combination have been shown to be effective in promoting PA and nutritionhave validated a taxonomy that lists 16 groups of CBTs 1 goal and planning 2 behavioral monitoring and feedback 3 social support 4 knowledge modification 5 behavioral consequences 6 behavioral comparison 7 associations 8 repetition and substitution 9 comparison of outcomes 10 behavior-related rewards and threats 11 regulation 12 antecedents 13 identity 14 anticipating consequences 15 self-conviction 16 imageryhidden learning
In a context where the scientific literature does not allow for the reproducibility of protocols which are often insufficiently described this taxonomy standardizes the language used in intervention studies and contributes to their readability and dissemination within the scientific community
By improving the observability and feasibility of the components of an intervention it becomes possible to develop effective individualized interventions that take into account the singularity of the individual and his or her situation With the aim of developing an optimal behavior-change intervention for elderly cancer patients further research is needed into understanding the mechanisms of action and the effect of CBTs on PA and nutrition behaviors To this end N-of-1 designs facilitate the development of individualized interventions taking into account intra-individual variability and the fluctuation of measured variables 27 In particular these N-of-1 designs have been recommended by the authors in recent research perspectives on CBT and PA behaviors and nutrition
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 67 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 mortalityReduced muscle mass is associated with over-toxicity to chemotherapies with a direct impact on survivalReduced 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
These recommendations apply to both primary age-related mass loss and secondary disease-related mass loss
Although an intervention combining nutritional monitoring and regular PA practice is recognized as effective in maintaining muscle status and preventing undernutrition it is difficult to achieve high adherence and lasting behavioural changes to move the elderly towards a more active lifestyle and to change their eating habits
The theory of planned behavior a theoretical approach that facilitates behavior change towards an active lifestyle associated with adapted nutritional behaviors
Identifying the motivational factors associated with PA and nutrition in this population could help facilitate the adoption and sustainability of these behaviours
The literature indicates that using a theoretical approach to identify motivational factors associated with PA and nutrition is important to facilitate behavior change and hope for higher adherence A meta-analysis has shown that no theory is superior to another in terms of effectiveness for modifying PA and that interventions are more effective when based on a single theory rather than a combination of theories In this respect the theory of planned behavior TCP is commonly used in the study of behavior change particularly for an aging population Figure 1 This theory assumes that the adoption of a behavior stems from the formation of intentions in the individual These intentions are facilitated by attitudes subjective norms particularly in the caregiver and self-perceived behavioral control
Attitudes represent the benefits perceived by the individual in performing the behavior ie benefits related to the usefulness of the behavior and those related to the pleasure of performing it
Subjective norms correspond to the individuals social influence represented by what those around him think of the behavior he wants to undertake
Perceived behavioral control refers to the perceived ease or difficulty of performing the behavior and thus to the individuals belief that he or she possesses the necessary resources to perform the behavior Moreover this variable is assumed to be directly related to behavior
However TCP has been criticized for its variable prediction of behavioral intentions Indeed the designs used are based on a limited number of measures failing to take into account the temporal fluctuation of perceptions and intra-individual variability In response to these methodological limitations Maher and colleagues investigated the use of repeated-measures methods to assess the relationship between intentions and behavior In particular the study revealed that intentions can vary according to the time of day reflecting the dynamics of motivational variables As a result repeated-measures methods are effective for measuring TCP variables as they identify the contexts most conducive to putting intentions into action
In this respect the Ecological Momentary Assessment EMA method enables repeated sampling of behaviors and psychological variables in real time which could take into account the temporal fluctuation of perceptions
This data collection method is suitable for measuring TCP variables and could improve their predictive level It is feasible with high compliance above 80 in the elderly
Behavior change techniques an effective individualized intervention to optimize the adoption and sustainability of health behaviors
In oncology and geriatrics intervention research indicates that an increase in TCP variables is accompanied by a significant increase in PA levels Interventions based on behavior change techniques BCT alone or in combination have been shown to be effective in promoting PA and nutritionhave validated a taxonomy that lists 16 groups of CBTs 1 goal and planning 2 behavioral monitoring and feedback 3 social support 4 knowledge modification 5 behavioral consequences 6 behavioral comparison 7 associations 8 repetition and substitution 9 comparison of outcomes 10 behavior-related rewards and threats 11 regulation 12 antecedents 13 identity 14 anticipating consequences 15 self-conviction 16 imageryhidden learning
In a context where the scientific literature does not allow for the reproducibility of protocols which are often insufficiently described this taxonomy standardizes the language used in intervention studies and contributes to their readability and dissemination within the scientific community
By improving the observability and feasibility of the components of an intervention it becomes possible to develop effective individualized interventions that take into account the singularity of the individual and his or her situation With the aim of developing an optimal behavior-change intervention for elderly cancer patients further research is needed into understanding the mechanisms of action and the effect of CBTs on PA and nutrition behaviors To this end N-of-1 designs facilitate the development of individualized interventions taking into account intra-individual variability and the fluctuation of measured variables 27 In particular these N-of-1 designs have been recommended by the authors in recent research perspectives on CBT and PA behaviors and nutrition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None