NCT05310045

Personalised Primary Prevention Intervention for Vulnerable Informal Caregivers at Increased Risk of Cancer

Prevention of Modifiable Cancer Risks in Informal Caregivers of Cancer Patients: Implementation and Evaluation of a Personalised Intervention for Vulnerable Informal Caregivers at Increased Risk of Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 126 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Today, 40% of cancers are linked to modifiable risk factors and could thus be preventable. Primary prevention, which allows individuals to be informed and aware of health recommendations and possible actions before the onset of a cancer, is thus a major public health issue. Around 11 million of French citizens are informal caregivers, i.e. people who regularly and frequently provide a non-professional help to do all or part of daily life activities for a dependent person with a disability, disease, or due to age. In cancer, there are around 5 million of informal caregivers in France. Studies have shown that informal caregivers of cancer patients are not only at risk for stress, anxiety, poor health, diminished quality of life, but also that they adopt so-called "risk behaviours" (e.g., increased smoking or alcohol consumption, unbalanced eating habits rich in fat, sugar and ultra-processed foods, sedentary lifestyle, etc.). These behaviours may develop or worsen co-morbidities and/or promote cancer development, outside hereditary context. Moreover, for certain types of cancer, related and unrelated family caregivers have a higher risk of developing cancer because they share the same lifestyle including the same risk factors. However, compared to general population, informal caregivers of cancer patients, have an increased risk perception and motivation to change a so-called unhealthy lifestyle. In this context, our goal is to test the feasibility and acceptability of a personalised primary prevention intervention designed to informal caregivers of cancer patients at increased risk of cancer. The intervention will be first designed to first-degree relatives and partners/spouses of a patient treated at Léon Bérard Center. Developed in the Léon Bérard comprehensive cancer centre in close relation with outpatient care and based on an informal caregiver's tracking questionnaire, the intervention will be composed of two consultations with a physician trained in primary prevention and information and referral to health prevention structures. As primary objectives, acceptability will be assessed based on informal caregivers' satisfaction and feasibility based on their participation rates. As secondary objectives, informal caregivers' knowledge and risk perception will be assessed based on questionnaires and intention to change or change behaviour will be noted and analysed through individual semi-structured interviews.

Conditions

• Informal Caregivers
• Healthy Volunteers
• Family
• Spouses

Interventions

Type	Name	Description
BEHAVIORAL	Personalised primary prevention intervention	Personalised primary prevention intervention 1. Consultation 1 * Assess caregiver's situation regarding their cancer risk factors * Explain the causal links between risk factors and cancer * Inform about national recommendations to prevent and limit cancer risk * Clarify informal caregiver situation with respect to national screening programs * Define a personalised primary prevention program 2. Implementation: personalised primary prevention program * Carried out by the informal caregiver * Supervised by the coordinating nurse 3. Consultation 2 * Assess prevention actions realised by informal caregiver in relation to actions defined in the personalised primary prevention program * Identify barriers and facilitators to their implementation whether actions or no actions have been done. * Adapt the personalised primary prevention program to informal caregiver needs.

Timeline

• Start date: 2022-04-04
• Primary completion: 2024-07-15
• Completion: 2024-07-15
• First posted: 2022-04-04
• Last updated: 2025-04-03

Locations

1 site across 1 country: France