Informal CaregiversPREV-AIDANTNCT05310045
Personalised Primary Prevention Intervention for Vulnerable Informal Caregivers at Increased Risk of Cancer
An observational study of Informal Caregivers and Healthy Volunteers, run by Centre Leon Berard at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Informal Caregivers, Healthy Volunteers, Family
- What is being tested?
- Personalised primary prevention intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2022to 15 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: First-degree relative and partner/spouse of a patient treated at the Centre Léon Bérard, at increased risk of cancer
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Personalised primary prevention intervention
- Keywords
- primary prevention, informal caregivers, cancer risk, personalised intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised primary prevention interventionBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the intervention
Acceptability will be assessed based on informal caregivers' satisfaction.
Measured: 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.
Measured: 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
Informal caregivers are identified with a tracking questionnaire. The percentage of informal caregivers who responded to the tracking questionnaire will be measured.
Measured: At the pre-inclusion
Adherence of informal caregivers to the different stages of the study: attendance to consultations
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.
Measured: 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
Experience will be analysed using individual semi-structured interviews.
Measured: After the 2nd consultation (4 to 6 months after inclusion)
Short-term impact of the personalised primary prevention intervention: knowledge
Knowledge will be measured by informal caregiver's through a knowledge score based on a questionnaire.
Measured: 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
Cancer risk perception will be measured by informal caregiver's through a cancer risk perception score, based on a questionnaire.
Measured: 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: Intention/behaviour change
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.
Measured: During the second consultation (4 to 6 months after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start4 Apr 2022
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Informal CaregiversStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Béatrice FERVERS, Principal investigator, Centre Léon Bérard (CLB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310045
- Sponsor's protocol ID
- PREV-AIDANT
- Acronym
- PREV-AIDANT
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2022
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not planning to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05310045
- Acronym / sponsor ID
- PREV-AIDANT / PREV-AIDANT
- Conditions
- Informal Caregivers, Healthy Volunteers, Family, Spouses
- Keywords
- primary prevention, informal caregivers, cancer risk, personalised intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- First-degree relative and partner/spouse of a patient treated at the Centre Léon Bérard, at increased risk of cancer
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalised primary prevention interventionPersonalised 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. | Behavioural | – |
Primary outcome
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.
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.
6 secondary outcomes
Adherence of informal caregivers to the different stages of the study: filling in the questionnaire
Time frame: At the pre-inclusion
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)
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)
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)
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)
Short-term impact of the personalised primary prevention intervention: Intention/behaviour change
Time frame: During the second consultation (4 to 6 months after inclusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No. We are not planning to share IPD
Related trials for Informal Caregivers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Béatrice FERVERS principal investigator
Centre Léon Bérard (CLB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Informal Caregivers and Healthy Volunteers, run by Centre Leon Berard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the intervention (time frame: At the end of the personalised primary prevention intervention (4 to 6 months after inclusion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.