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

NCT ID: NCT05310045

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 126 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-04
• Study Completion Date: 2024-07-15

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• First-degree relative and partner/spouse of a patient treated at the Centre Léon Bérard;
• At increased risk of cancer
• Aged between 18 and 75 years;
• No diagnosis of genetic predisposition to cancer and no personal or informal history suggesting genetic predisposition;
• Able to complete a questionnaire in French, alone or with the help of a relative (persons with visual, mute, motor, hearing or intellectual disabilities will be included as long as they are able to complete a questionnaire alone or with the help of a relative);
• Being informed and not opposed to the study ;
• Having completed the entire tracking questionnaire and wishing to be contacted.

Exclusion Criteria

• Related or unrelated relative not considered as an informal caregiver for the patient;
• Minor informal caregiver;
• Informal caregiver with a history of cancer;
• Patient under care at the Institute of Hematology and Pediatric Oncology;
• Individuals of legal age protected by law.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Béatrice FERVERS

Role: PRINCIPAL_INVESTIGATOR

Centre Léon Bérard (CLB)

Locations

Centre Leon Berard

Lyon, , France

Countries

France

Other Identifiers

PREV-AIDANT

Identifier Type: -

Identifier Source: org_study_id