Clinical trial NCT05310045: Personalised Primary Prevention Intervention for Vulnerable Informal Caregivers at Increased Risk of Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Informal Caregivers
Healthy Volunteers
Family
Spouses
Keywords: primary prevention
informal caregivers
cancer risk
personalised intervention
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.


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.

Primary outcomes:
measure: Acceptability of the intervention
timeFrame: At the end of the personalised primary prevention intervention (4 to 6 months after inclusion)
measure: Feasibility of the intervention
timeFrame: At the end of the personalised primary prevention intervention (4 to 6 months after inclusion)
Secondary outcomes:
measure: Adherence of informal caregivers to the different stages of the study: filling in the questionnaire
timeFrame: At the pre-inclusion
measure: Adherence of informal caregivers to the different stages of the study: attendance to consultations
timeFrame: At the end of the 1st (2 to 6 weeks after inclusion) and the 2nd consultation (4 to 6 months after inclusion)
measure: Experience, of informal caregivers who have benefited from all the personalised primary prevention intervention
timeFrame: After the 2nd consultation (4 to 6 months after inclusion)
measure: Short-term impact of the personalised primary prevention intervention: knowledge
timeFrame: Before the 1st (2 to 6 weeks after inclusion) and the 2nd consultation (4 to 6 months after inclusion)
measure: Short-term impact of the personalised primary prevention intervention: cancer risk perception
timeFrame: Before the 1st (2 to 6 weeks after inclusion) and the 2nd consultation (4 to 6 months after inclusion)
measure: Short-term impact of the personalised primary prevention intervention: Intention/behaviour change
timeFrame: During the second consultation (4 to 6 months after inclusion)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Leon Berard
Study officials:
affiliation: Centre Léon Bérard (CLB)
name: Béatrice FERVERS
role: PRINCIPAL_INVESTIGATOR
References: