Dynamics of Motivational Factors for Physical Activity and Nutrition in Oncogeriatrics

NCT06445140 | Recruiting

• 1 other identifier: PROICM 2024-01 MON
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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. 1.to identify clusters/groups in patients on the basis of daily motivational factors focusing on PA and nutrition
2. 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.

Conditions

Cancer

Keywords

oncogeriatry

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  from baseline at 15 days

• For Interventionnal phase : Improving nutrition behaviors of elderly cancer patients

  Quality of nutrition questionnaire (Ingestas)

  from baseline at 12 weeks

• For Interventionnal phase : Improving physical activity behaviors of elderly cancer patients

  Number of physical activities

  from baseline at 12 weeks

Secondary Outcomes (2)

• 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

Study Arms (1)

Observation phase and Intervention phase

EXPERIMENTAL

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\*.

Behavioral: Collecting the variables and Implementation of a behavioural intervention

Interventions

Collecting the variables and Implementation of a behavioural intervention BEHAVIORAL

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

Observation phase and Intervention phase

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient aged 70 or over
• With cancer (solid tumors, all sites)
• G8 ≤ 14
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Institut Du Cancer de Montpellier

Montpellier, France

RECRUITING

Related Publications (1)

• Fabbro M, Lamy PJ, Touraine C, Floquet A, Ray-Coquard I, Mollevi C. HE4 and CA-125 kinetics to predict outcome in patients with recurrent epithelial ovarian carcinoma: the META4 clinical trial. Front Oncol. 2024 Jan 11;13:1308630. doi: 10.3389/fonc.2023.1308630. eCollection 2023.

  PMID: 38273857 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• GALLET SUCHET BLANDINE

  Institut du Cancer de Montpellier - Val d'Aurelle

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MOUSSION AURORE

CONTACT

0467613102; aurore.moussion@icm.unicancer.fr

GALLET SUCHET BLANDINE

CONTACT

+334 67 61 3055; Blandine.Gallet@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 6, 2024
• Study Start: June 18, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

FR (1)