Centre Leon Berard
Lyon, 69373, France
NCT Number: NCT05310045
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.
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Notify Me18 year–75 year
All sexes
Observational
Lyon, 69373, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Personalised primary prevention intervention
Time frame: At the end of the personalised primary prevention intervention (4 to 6 months after inclusion)
Acceptability will be assessed based on informal caregivers' satisfaction.
Time frame: At the end of the personalised primary prevention intervention (4 to 6 months after inclusion)
Feasibility will be assessed based on informal caregivers' participation rates.
Time frame: At the pre-inclusion
Informal caregivers are identified with a tracking questionnaire. The percentage of informal caregivers who responded to the tracking questionnaire will be measured.
Time frame: At the end of the 1st (2 to 6 weeks after inclusion) and the 2nd consultation (4 to 6 months after inclusion)
The personalised primary prevention intervention is composed of 2 consultations. The percentage of informal caregivers who participated to the 1st and 2nd consultation will be measured.
Time frame: After the 2nd consultation (4 to 6 months after inclusion)
Experience will be analysed using individual semi-structured interviews.
Time frame: Before the 1st (2 to 6 weeks after inclusion) and the 2nd consultation (4 to 6 months after inclusion)
Knowledge will be measured by informal caregiver's through a knowledge score based on a questionnaire.
Time frame: Before the 1st (2 to 6 weeks after inclusion) and the 2nd consultation (4 to 6 months after inclusion)
Cancer risk perception will be measured by informal caregiver's through a cancer risk perception score, based on a questionnaire.
Time frame: During the second consultation (4 to 6 months after inclusion)
Intention/behaviour change will be measured by the percentage of actions planned in the personalised primary prevention programme and actually carried out by the informal caregiver.
Centre Leon Berard
Other
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
Acronym: PREV-AIDANT
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