Skip to main content
OpenTrials
Completed

NCT Number: NCT05310045

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Leon Berard

Lyon, 69373, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Personalised primary prevention intervention

Behavioral

Personalised primary prevention intervention

  • 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
  • Implementation: personalised primary prevention program
  • Carried out by the informal caregiver
  • Supervised by the coordinating nurse
  • 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.

Primary outcomes

  1. Acceptability of the 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.

  2. Feasibility of the intervention

    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.

Secondary outcomes

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

    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.

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

    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.

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

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

    Experience will be analysed using individual semi-structured interviews.

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

    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.

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

    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.

  6. Short-term impact of the personalised primary prevention intervention: Intention/behaviour change

    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.

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study 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

Acronym: PREV-AIDANT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 4, 2022
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.