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

NCT05310045 | Completed

• 1 other identifier: PREV-AIDANT
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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

Keywords

primary prevention; informal caregivers; cancer risk; personalised intervention

Outcome Measures

Primary Outcomes (2)

• Acceptability of the intervention

  Acceptability will be assessed based on informal caregivers' satisfaction.

  At the end of the personalised primary prevention intervention (4 to 6 months after inclusion)

• Feasibility of the intervention

  Feasibility will be assessed based on informal caregivers' participation rates.

  At the end of the personalised primary prevention intervention (4 to 6 months after inclusion)

Secondary Outcomes (6)

• Adherence of informal caregivers to the different stages of the study: filling in the questionnaire

  At the pre-inclusion

• Adherence of informal caregivers to the different stages of the study: attendance to consultations

  At the end of the 1st (2 to 6 weeks after inclusion) and the 2nd consultation (4 to 6 months after inclusion)

• Experience, of informal caregivers who have benefited from all the personalised primary prevention intervention

  After the 2nd consultation (4 to 6 months after inclusion)

• Short-term impact of the personalised primary prevention intervention: knowledge

  Before the 1st (2 to 6 weeks after inclusion) and the 2nd consultation (4 to 6 months after inclusion)

• Short-term impact of the personalised primary prevention intervention: cancer risk perception

  Before the 1st (2 to 6 weeks after inclusion) and the 2nd consultation (4 to 6 months after inclusion)

Interventions

Personalised primary prevention intervention BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

First-degree relative and partner/spouse of a patient treated at the Centre Léon Bérard, at increased risk of cancer

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Leon Berard

Lyon, 69373, France

Location

Study Officials

• Béatrice FERVERS

  Centre Léon Bérard (CLB)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 4, 2022
• Study Start: April 4, 2022
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)