Trial Title:
Dynamics of Motivational Factors for Physical Activity and Nutrition in Oncogeriatrics
NCT ID:
NCT06445140
Condition:
Cancer
Conditions: Keywords:
oncogeriatry
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Collecting the variables and Implementation of a behavioural intervention
Description:
The observational phase (during 15 days)
- Two measurements per day for motivational variables and physical activity and
nutrition
- Two measurements per day for nutrition
- Three measurements per day for fatigue
- Continuous PA measurement by accelerometer
The interventional phase :
Part A (during 7 days)
- measuring physical activity (PA)
- complete questionnaires and numerical scales :
- Motivational factors
- Self-evaluation of nutrition
- Self-assessment of fatigue
Part B: BEHAVIORAL INTERVENTION (10 weeks),the APA teacher will call a patient once a
week for follow-up.
Answer questionnaires and scales on the digital platform will be done :
- Motivational factors
- Self-evaluation of nutrition
- Self-assessment of fatigue
Part C : End of interventional phase(during 7 days)
- measuring physical activity
- complete questionnaires and numerical scales :
- Motivational factors
- Self-evaluation of nutrition
- Self-assessment of fatigue
Arm group label:
Observation phase and Intervention phase
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 clusters/groups 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 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.
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 showń that no theory is superior to
another in terms of effectivenesś 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, i.e. benefits related to the usefulness of the behavior and those related
to the pleasure of performing it.
- Subjective norms correspond to the individual's 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 individual's 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. identitý, 14.
anticipating consequences, 15. self-conviction, 16. imagery/hidden 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patient aged 70 or over
2. With cancer (solid tumors, all sites)
3. G8 ≤ 14
4. Inactive (patient not meeting recommended physical activity levels of 150 minutes
per week at moderate intensity)
5. Patient has given informed, written and express consent
6. Patient affiliated to a French social security scheme.
Exclusion Criteria:
1. Known presence of brain metastases
2. Inability to participate in digital platform assessments or physical tests
3. Inability to eat orally
4. Contraindication or inability to engage in physical activity
5. Patient unable to follow up regularly for psychological, family, numerical, social
or geographical reasons
6. Person deprived of liberty or under protective custody or guardianship.
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Du Cancer de Montpellier
Address:
City:
Montpellier
Country:
France
Status:
Recruiting
Contact:
Last name:
MOUSSION AURORE
Phone:
0467613102
Email:
aurore.moussion@icm.unicancer.fr
Investigator:
Last name:
GALLET SUCHET BLANDINE
Email:
Principal Investigator
Investigator:
Last name:
BRUSSEAU MATHIS
Email:
Sub-Investigator
Start date:
June 18, 2024
Completion date:
September 30, 2026
Lead sponsor:
Agency:
Institut du Cancer de Montpellier - Val d'Aurelle
Agency class:
Other
Source:
Institut du Cancer de Montpellier - Val d'Aurelle
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06445140
